Fosun Pharma and Henlius Entered into an Exclusive License Agreement for Serplulimab in the US

PRINCETON, N.J., Jan. 7, 2023 /PRNewswire/ — Fosun Pharma (600196.SH, 02196.HK) has recently entered into an exclusive license agreement with Shanghai Henlius Biotech, Inc. (2696.HK) for the commercialisation of Henlius independently developed anti-PD-1 monoclonal antibody (mAb) serplulimab in the United States (US). This marks an important milestone for Fosun Pharma’s development in the US.

Fosun Pharma will have the right to commercialise serplulimab upon approval in the US, and Henlius will retain responsibility for development, manufacturing, and supply. For many years, the two companies have worked closely on product commercialisation and other areas, developing consensus in terms of corporate vision and values, global development strategy, product operations, and management communication while focusing on patients’ and clinical needs. Through this collaboration, the two parties aim to intensively develop serplulimab, integrate superior resources, cooperate in securing approval, and promote its rapid launch in the United States to benefit more patients.

Mr. Wu Yifang, Chairman of Fosun Pharma, said, “We are very happy to make full use of Fosun Pharma’s accumulated innovation capabilities, internationalization advantages and commercialization capabilities over the years to promote the commercialization of an approved anti-PD-1 mAb serplulimab in the US market and help benefit more patients around the world. Fosun Pharma has always been patient-centered and clinical needs-oriented. We have been practicing internationalization strategies in the dimensions of innovative R&D, license introduction, production operation and commercialization, and continuously strengthening the construction of full capacity in global operations.”

Mr. Wenjie Zhang, Chairman and CEO of Henlius, said, “We are excited to partner with Fosun Pharma in the United States on serplulimab. The impressive clinical data of serplulimab was published in the top international medical journal and has gained international attention. As we move forward, we’ll seek approvals for additional indications in China, the US, and the European Union. In the US, Fosun Pharma has a fast-growing commercialisation team and a dedicated sales network. Together, we will, upon approval, accelerate the launch of this differentiated anti-PD-1 mAb in the US market and benefit more overseas patients with high-quality biological drugs.”

Joining Forces for a Global Blueprint

Founded in 1994, Fosun Pharma is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma strengthens its independent R&D and external cooperation and enriches its product pipelines, as well as promotes global networks. Thanks to its industry-leading two-way licensing capabilities and international advantages, Fosun Pharma helps maximize the value of innovative products of partners. In the international layout, Fosun Pharma focuses on building the U.S. operation center and conducts all-around capacity building in R&D, production, and sales in the local market. On the important partnership in the U.S. for serplulimab, and the potential impact on patients with lung cancer, Mr. Rong Yang, Senior Vice President of Fosun Pharma and CEO of Fosun Pharma USA Inc. said, “It is a very important step for us, an opportunity to be a part of the community, and serving patients with critical unmet needs, and making a difference every day.”

Fully leveraging the experience of biologics development and harnessing the power of innovation, Henlius has built a vertically integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle, including R&D, manufacturing and commercialisation, laying the solid foundation for a diversified and robust innovation pipeline. To date, 5 products have been successfully marketed in China, and 1 approved for marketing in overseas markets. The pipeline of products under development covers targets with great market potential, such as PD-1, HER2, EGFR, BRAF, etc. Synergising the innovation centres in China and the US and global product development teams, Henlius continues the momentum for a diversified innovation product pipeline and has conducted more than 20 clinical trials in China, the EU, the US, Australia, etc. with more than 70 clinical trial approvals worldwide. In terms of manufacturing capabilities, Henlius strictly follows the International Good Manufacturing Practice (GMP) standards for production and quality control. The products in the pipeline are produced by Henlius’s self-built manufacturing facilities, with rich production experience from clinical stages to commercialised products. Also, the manufacturing facilities have successfully passed the on-site inspection conducted by NMPA, the European Medicines Agency, the EU qualified person, and multiple international business partners, and are certified by China and EU GMP. Henlius’ strong R&D capabilities, international-standard quality management system, and production capacity enable Henlius to boost the global commercialisation of its products.

About HANSIZHUANG

HANSIZHUANG, as the product is known in China, (recombinant humanised anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first innovative monoclonal antibody developed by Henlius. Up to date, 2 indications are approved for marketing in China, 2 NDAs have been accepted by the NMPA, and more than 10 clinical trials are ongoing across the world.

HANSIZHUANG was launched in China in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours and squamous non-small cell lung cancer (sqNSCLC). Its synergy with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 12 clinical trials on immuno-oncology combination therapies in a wide variety of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer, etc., and covering the full range of first-line treatments of lung cancers. As of now, the company has enrolled more than 3,100 subjects in China, Turkey, Poland, Georgia and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The NDAs of the first-line treatment for squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC) have been accepted by the NMPA, which makes HANSIZHUANG potentially the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. Furthermore, HANSIZHUANG was recommended for the treatment of ES-SCLC in the 2022 CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer (SCLC), and the associated clinical trial became the first study published in JAMA on SCLC immunotherapy. Serplulimab was also granted orphan drug designations by the FDA and EC for the treatment of SCLC, and the first patient has been dosed in a bridging head-to-head trial in the United States to comparing HANSIZHUANG to standard of care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC.

About Fosun Pharma

Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group deep-rooted in China. Fosun Pharma directly operates businesses including pharmaceutical manufacturing, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business.

Fosun Pharma is patient-centered and clinical needs-oriented. The company enriches its innovative product pipeline through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma has formed technological platforms for innovative small molecule drugs, antibody drugs, and cell therapy with a focus on key disease areas including oncology and immunomodulation, metabolism and digestive system, as well ascentral nervous system. Fosun Pharma also vigorously explores cutting-edge technologies, such as RNA, gene therapy, ADC and PROTAC, to enhance its innovation capabilities.

Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma will uphold the development model of “innovation transformation, integrated operation, and steady growth”, with the mission of creating shareholder values through strengthening its independent R&D and external cooperation and enriching its product pipelines, as well as promoting the global networks and enhancing operational efficiency. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global medical and health market.

For more information, please visit our official website: www.fosunpharma.com.

About Fosun Pharma USA Inc.

Fosun Pharma USA Inc., a subsidiary of Fosun Pharma, was founded in 2017 and continually works to enhance our existing portfolio of specialty pharmaceutical injectables and to build our pipeline with both innovative and generic pharmaceutical drugs. With strategic manufacturing partnerships around the world, Fosun Pharma USA Inc. delivers high-quality products that comply with international standards.

For more information, please visit our official website: https://fosunpharmausa.com/

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 approved for marketing in overseas markets, 15 indications approved worldwide, and 4 New Drug Applications (NDAs) accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialisation. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name in Europe: Zercepac^®; trade names in Australia: Tuzucip^® and Trastucip^®, the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours and squamous non-small cell lung cancer (sqNSCLC). Its NDAs for the treatment of extensive-stage small cell lung cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC) are under review. What’s more, Henlius has conducted over 20 clinical studies for 15 products and 12 immuno-oncology combination therapies, expanding its presence in major markets as well as emerging markets.

SOURCE Fosun Pharma

 

Fosun Pharma and MAIA Pharmaceuticals Jointly Announce the Successful Commercialization of Only FDA Approved 20ml Sodium Phenylacetate and Sodium Benzoate (SPSB) Liquid Product

PRINCETON, N.J., Sept. 26, 2022 /PRNewswire/ — Shanghai Fosun Pharma (Group) Co., Ltd. (“Fosun Pharma”, stock code: 600196.SH; 02196.HK) today announced that the 20 ml, Sodium Phenylacetate and Sodium Benzoate (SPSB) liquid product, which is under an exclusive partnership between Fosun Pharma USA Inc. (“Fosun Pharma USA“), the US-based subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196. SH, 02196. HK) and MAIA Pharmaceuticals, Inc. (MAIA), a Princeton, NJ based specialty pharmaceutical company, has been recently launched. Fosun Pharma USA has the exclusive commercial rights of this product in the U.S. market.

Based upon market feedback, the usage of 50ml SPSB, as prescribed, predominantly in the pediatric setting, is subject to extensive product wastage which is a huge cost to the healthcare system. SBSP is available in 20 ml and 50 ml vial sizes. Currently, only MAIA has the FDA approval for the 20 ml vial size.

Rong Yang, Chief Executive Officer of Fosun Pharma USA Inc. and Senior Vice President of Fosun Pharma said, “We are excited that this product in partnership with MAIA has been recently launched which marks a milestone for Fosun Pharma’s business development in the US market.”

Jeremy L. Tatum, Chief Commercial Officer and General Manager of Generics, Fosun Pharma USA Inc. said, “By producing the only commercially available and FDA approved 20 ml SPSB product, MAIA and Fosun Pharma USA are addressing the need to reduce wastage and reduce unnecessary spending on critically needed products. We are ready to ship the Product. For Fosun Pharma USA, this is the first of many 505(b)(2) that will be launched over the next few years.”

About Fosun Pharma USA Inc.

Fosun Pharma USA Inc., a subsidiary of Fosun Pharma, was founded in 2017 and continually works to enhance our existing portfolio of specialty pharmaceutical injectables and to build our pipeline with both innovative and generic pharmaceutical drugs. With strategic manufacturing partnerships around the world, Fosun Pharma USA Inc. delivers high-quality products that comply with international standards.

For more information, please visit our official website: https://fosunpharmausa.com/

About Fosun Pharma

Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group deep-rooted in China. Fosun Pharma directly operates businesses including pharmaceutical manufacturing, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business.

Fosun Pharma is patient-centered and clinical needs-oriented. The company enriches its innovative product pipeline through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma has formed technological platforms for innovative small molecule drugs, antibody drugs, and cell therapy with a focus on key disease areas including oncology and immunomodulation, metabolism and digestive system, as well as central nervous system. Fosun Pharma also vigorously explores cutting-edge technologies, such as RNA, gene therapy, ADC and PROTAC, to enhance its innovation capabilities.

Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma will uphold the development model of “innovation transformation, integrated operation, and steady growth”, with the mission of creating shareholder values through strengthening its independent R&D and external cooperation and enriching its product pipelines, as well as promoting the global networks and enhancing operational efficiency. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global medical and health market.

For more information, please visit our official website: www.fosunpharma.com

About MAIA Pharmaceuticals, Inc.

MAIA Pharmaceuticals is a specialty pharmaceutical company that identifies, develops, manufactures and markets innovative and niche hospital products. It specializes in Injectables, Niche Generic, Diagnostics, Hormones, Oncology, Steroids, and Controlled/Sustained Release. MAIA Pharmaceuticals is headquartered in Princeton, NJ.

SOURCE Fosun Pharma

Fosun Pharma and VerImmune enter into an Exclusive License and Option Agreement  for
VerImmune’s Virus-inspired Particle (ViP) platform as Novel Immunotherapies in China

• Novel Anti-tumor Immune Redirection Virus-inspired Particle (AIR-ViP) cancer immunotherapies initially to be developed by VerImmune Inc.
• Fosun Pharma to lead clinical development and commercialization in the Chinese Mainland, Hong Kong and Macau Special Administration Region and Taiwan Region.
• For AIR-ViP product candidate, VERI-101, VerImmune is eligible for up to $125M in total upfront and milestone payments plus tiered royalties up to the low double digits on net sales in the specified territories.
• VerImmune is also eligible for additional milestone payments and tiered royalties subject to Fosun Pharma’s exercise of its option to select other AIR-ViP product candidates.

(May 23, 2022, Princeton, NJ) Fosun Pharma USA Inc., the US-based subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Stock Code: 600196.SH, 02196.HK) (collectively “Fosun Pharma”), and VerImmune Inc. (“VerImmune”), a privately-held biotechnology company developing a novel therapeutic Virus-Inspired Particle (ViP) modality that redirects the body’s pre-existing immunity against viral pathogens to attack cancer, announced today that the companies have entered into an Exclusive License and Option agreement effective May 18, 2022.

 

Under the terms of the agreement, VerImmune has granted Fosun Pharma an exclusive license to VerImmune’s lead AIR-ViP product candidate, VERI-101, with an option to license certain potential future AIR-ViP products arising from the development of VerImmune’s VERI-101 pipeline for the territory of Chinese Mainland, Hong Kong and Macau Special Administration Regions and Taiwan Region.  Fosun Pharma will be responsible for all clinical development and commercialization in these territories.

 

VerImmune is eligible to receive up to $125M in total upfront and milestone payments plus tiered royalties up to the low double digits on net sales of VERI-101 in specified territories. Subject to Fosun Pharma’s exercise of its option to select future AIR-ViP product candidates, VerImmune is eligible to receive additional milestone payments and royalties on net sales for each additional product candidate.

 

“The field of cancer immunotherapy is the frontier of current biomedical research, and it is also one of the key directions of Fosun Pharma’s strategic layout.” commented Wu Yifang, Chairman and CEO of Fosun Pharma. “We are pleased to partner with VerImmune to bring such a promising immunotherapy to China, and hope the cutting-edge biotherapeutic technologies and products can benefit more patients in China.”

 

“Cancer is a global unmet medical need and thus we are very excited to be working with the Fosun Pharma companies to bring our novel lead AIR-ViP immunotherapeutic products to China. Fosun Pharma has both the expertise and access to reach these fast-growing markets and we hope to benefit more Chinese patients and the region through our cooperation” said Joshua Wang, Ph.D., VerImmune Founder and CEO.

 

VerImmune’s core technology is an innovative Virus-inspired Particle (ViP) platform technology that can be used as a delivery system to attack cancer. Building upon this highly adaptable ViP platform, VerImmune has developed a First-in-Class novel therapeutic strategy called “Anti-tumor Immune Redirection” (AIR). This approach uses the ViP platform (now termed AIR-ViP) to redirect natural pre-existing immunity from past viral infections or childhood vaccinations to target cancer.

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About Fosun Pharma

Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group in China. Fosun Pharma directly operates businesses including pharmaceutical manufacturing, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business.

 

Fosun Pharma is patient-centered and clinical needs-oriented. The company enriches its innovative product pipeline through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma has formed technological platforms for innovative small molecule drugs, antibody drugs, and cell therapy with a focus on key disease areas including oncology and immunomodulation, metabolism and digestive system, and central nervous system. Fosun Pharma also vigorously explores cutting-edge technologies, such as RNA, oncolytic viruses, gene therapy and PROTAC, to enhance its innovation capabilities.

 

Guided by the 4IN strategy (Innovation, Internationalization, Integration, and Intelligentization), Fosun Pharma will uphold the development model of “innovation transformation, integrated operation, and steady growth”, with the mission of creating shareholder values as well as promoting the global networks through strengthening its innovative R&D and in-licensing ability and enriching its product pipelines. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global mainstream medical and health market.
For more information, please visit our official website: www.fosunpharma.com

Fosun Pharma USA Inc., a subsidiary of Fosun Pharma, was founded in 2017 and continually works to enhance our existing portfolio of specialty pharmaceutical injectables and to build our pipeline with both innovative and generic pharmaceutical drugs. With strategic manufacturing partnerships around the world, Fosun Pharma USA Inc. delivers high-quality products that comply with international standards.

About VerImmune
VerImmune is an early-stage biotechnology company developing a first-in-class cancer therapy known as Anti-tumor Immune Redirection (AIR). This strategy utilizes a proprietary wholly owned virus-inspired particle (ViP) platform that redirects pre-existing pathogenic or childhood vaccine immune memory towards tumors. This unique mechanism of action allows differentiation within the competitive Immuno-Oncology market. Importantly, it potentially changes the treatment paradigm for many patients who have untreatable cancers due to limited options or resistance.
For more information visit: http://www.verimmune.com

Fosun Pharma 2021 Annual Results Announcement Accelerating the Globalization Comprehensively
The Proportion of Revenue from Innovative Products Continues to Increase

Highlights:
· Revenue for the year ended December 31, 2021 was RMB39,005 million, representing an increase of 28.70% YOY;
· The proportion of revenue from new products as well as regions outside Mainland China and countries overseas continue to increase, continuously optimizing the revenue structure;
· In 2021, the revenue from new and sub-new products including COMIRNATY® (mRNA COVID-19 vaccine, also known as BNT162b2), Han Li Kang, Han Qu You and Su Ke Xin accounted for over 25% of the revenue in the pharmaceutical manufacturing segment;
· Revenue from regions outside Mainland China and countries overseas reached RMB13,599 million, accounting for 34.86% of the total revenue, marking a step forward on globalization.

(22 March 2022, Shanghai, China) 22 March 2022, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma” or “the Group”; Stock Code: 600196.SH, 02196.HK), a global innovation-driven pharmaceutical and healthcare industry group in China, announced its annual results for the year of 2021 (“the Reporting Period”), together with its 2021 Corporate Social Responsibility (CSR) report.

Under the guidance of the 4IN strategy (Innovation, Internationalization, Integration and Intelligentization), Fosun Pharma continues to adhere to the business philosophy of “Innovation for Good Health” by promoting innovation and transformation, accelerating globalization, strengthening the integrations of R&D, supply chain, manufacturing and commercialization to further improve business operation and operating efficiency and to realize steady financial growth.

Revenue for 2021 was RMB39,005 million, representing an increase of 28.70% YOY. Revenue from regions outside Mainland China and countries overseas accounts for 34.86% of the total revenue. The net profit attributable to shareholders of the listed company amounted to RMB4,735 million, representing an increase of 29.28% YOY. The net profit attributable to shareholders of the listed company after the one-off gain amounted to RMB3,277 million, representing an increase of 20.60% YOY. Net operating cash flow was RMB3,949 million, representing an increase of 53.07% YOY.

Continuously increasing R&D investment and promoting innovation and transformation
Innovative R&D is the core driver for sustainable growth of Fosun Pharma. The Group had built in-house R&D, co-development, in-licensing and incubation capabilities and had established platforms for small molecule innovative drugs, antibody drugs and cell therapy products, focusing on major therapeutic areas, including oncology, immunology, metabolism and digestive system, and central nervous system. Fosun Pharma also keeps close track of cutting-edge technologies, such as RNA, oncolytic virus, gene therapy and targeted protein degradation, to enhance its innovation ability. The development of innovative technologies and products is accelerated under the management of global R&D center.

Fosun Pharma strategically increases R&D investment. The annual R&D expenditure was RMB4,975 million, representing an increase of 24.28% YOY; R&D expense was RMB3,834 million, representing an increase of RMB1,039 million and 37.17% YOY.

The R&D expenditure of the pharmaceutical manufacturing segment was RMB4,486 million, representing an increase of 22.23% YOY, accounting for 15.52% of the revenue from the segment. Pharmaceutical R&D expense amounted to RMB3,359 million, representing an increase of RMB891 million and 36.10% YOY, accounting for 11.62% of the revenue from the segment.

By the end of 2021, the Group had over 2,800 R&D professionals (over 1,500 professionals with master’s degree or higher), representing approximately 7.85% of the total employees in the Group. By the end of 2021, the Group had over 240 pipeline projects, including innovative candidates, biosimilars, generic candidates and consistent evaluation of generic candidates.

After over a decade of continuous investment, innovative products including Han Li Kang (Rituximab Injection), Han Qu You (Trastuzumab Injection), Su Ke Xin (Avatrombopag Maleate Tablets) and COMIRNATY® (mRNA COVID-19 vaccine) have been approved and sold in large quantities in the past three years, accelerating the implementation of innovative R&D and driving sustainable growth of the Group. In 2021, the revenue from new and sub-new products accounted for more than 25% of revenue in the pharmaceutical manufacturing segment. The revenue structure is continuously optimized.

Sales from in-house developed product Han Li Kang (Rituximab Injection) reached RMB1,690 million, representing an increase of 125.33% YOY. Han Qu You (Trastuzumab Injection) and Su Ke Xin (Avatrombopag Maleate Tablets), both launched in 2H 2020, recorded revenue of RMB930 million and RMB426 million respectively in 2021. Gland Pharma’s revenue in 2021 increased by 29.48% YOY (according to Gland Pharma’s financial statements in local currency), benefited from the contribution from Micafungin, Enoxaparin Sodium Injection and new products launch.

COMIRNATY® (mRNA COVID-19 vaccine) jointly developed by Fosun Pharma and BioNTech, was included in the government vaccination programs in Hong Kong SAR and Macau SAR in March 2021 and supplied to the Taiwan region in September 2021. By the end of February 2022, over 20 million doses of BNT162b2 have been administrated in Hong Kong SAR, Macau SAR, and Taiwan region, helping to establish the local COVID-19 immune barrier.

In June 2021, Yi Kai Da (Axicabtagene Ciloleucel Injection) of Fosun Kite, a joint venture, became the first CAR-T cell therapy product approved for launch in China, offering the possibility of sustained remission for patients with lymphoma after two or more lines of systemic therapy. Since the launch of Yi Kai Da, Fosun Kite has been exploring diversified and innovative payment methods to increase product accessibility to benefit more patients. As of the end of February 2022, Yi Kai Da has been included in the urban inclusive supplementary medical insurance and over 40 commercial insurance in 23 provinces and cities, and the number of registered treatment centers has reached 75. In addition, around one hundred patients have entered into the treatment process.

Fosun Pharma has a strong innovative medicine pipeline. The New Drug Application (NDA) for the treatment of microsatellite instability-high (MSI-H) solid tumours has been accepted by the National Medical Products Administration (NMPA) with priority review. The NDA for locally advanced and metastatic squamous non-small cell lung cancer (sqNSCLC), has also been accepted by the NMPA. Han Bei Tai (bevacizumab biosimilar) and Yi Bao (human erythropoietin for injection) for the treatment chemotherapy-induced anemia in patients with non-myeloid malignancies were approved for launch in Mainland China.

Continuously strengthening the global operation capability and making further enhancement
For globalization, Fosun Pharma has formed a global operating system for R&D, manufacturing and commercialization, and continuously expands overseas markets. Revenue in regions outside the Chinese Mainland and overseas countries in 2021 was RMB13,599 million, accounting for 34.86% of the total revenue. Globalization capability is continuously strengthened. The second headquarters in the United States help to build a global business landscape with full coverage of R&D, manufacturing and commercialization.

By the end of 2021, Fosun Pharma’s overseas commercialization team with over 1,200 employees has built marketing platforms in the United States, Africa and Europe and has achieved direct sales of formulations to the U.S. market. The medical device segment, including Sisram Medical and Breas, has covered China, the United States, Europe and other major regions. The COVID-19 test kit by Fosun Diagnostics has been sold in over ten countries. In 2021, the first regional center for drug distribution in Africa, the Côte d’Ivoire distribution center, was officially put into service, winning a substantial sales breakthrough in South Sudan. Gland Pharma, a holding subsidiary in India, received approvals from the US FDA for 13 generic drugs in 2021.

Leveraging the current global manufacturing capability and world-class manufacturing facilities including Yao Pharma, Guilin Pharma and Wanbang Biopharm with International GMP certification, Fosun Pharma has accelerated the acquirement of international GMP certification of domestic production lines, laying a solid foundation for exporting domestic products. In January and March 2022, Fosun Pharmaceutical Industrial obtained the Medicines Patent Pool (MPP)’s license to produce and supply the generic version of Merck’s oral COVID-19 treatment Molnupiravir and Pfizer’s oral COVID-19 treatment Nirmatrelvir, as well as the co-packaged product of Nirmatrelvir and Ritonavir of Pfizer, to agreed low- and middle-income countries. The license includes both ingredients and the finished drug. Through this license, Fosun Pharma devoted itself further to fighting against the pandemic around the world.

As of January 2022, the total number of Fosun Pharma’s WHO-PQ-approved antimalarial series products has increased to 30, including 26 preparations and 4 API products, making Fosun Pharma the antimalarial drug manufacturer with the most certifications.

Accelerating the strategic upgrade and internal integration to drive specialization
In 2021, Fosun Pharma actively promoted the integration of systems and resources in R&D, supply chain, manufacturing and commercialization to enhance synergies and operational efficiency and promote solid financial growth. The Group’s core business, the pharmaceutical manufacturing segment, achieved revenue of RMB28,904 million; the medical devices and medical diagnosis segment achieved revenue of RMB5,938 million, and the healthcare services segment achieved revenue of RMB4,118 million in 2021.

During the Reporting Period, Fosun Pharma promoted the strategic integration of the manufacturing facilities by sorting out the advantageous production capacity within the pharmaceutical manufacturing segment, strengthening the supply chain management and accelerating the construction of competitive manufacturing facilities. In early 2022, the pharmaceutical manufacturing segment was upgraded and divided into Innovative Medicines Division, Established Medicines Manufacturing & Supply Division and Vaccines Division to clarify business boundaries with divisions and accelerate specialization.

During the Reporting Period, the medical devices and medical diagnosis segments continued to strengthen their independent operation capability. Through business integration, the medical devices segment has initially formed three major business divisions with medical aesthetics, respiratory care and professional medical care. Sisram, the core platform for medical aesthetics, actively expanded the original energy-based medical aesthetic equipment business and simultaneously developed aesthetic dentistry, injectables and personal care business units, to accelerate the construction of the medical aesthetic ecosystem.

During the Reporting Period, Fosun Pharma has completed its review of the medical diagnosis segment and has initially realized the integration of operation. To cope with the strategic layout of the medical diagnosis business, Fosun Pharma has completed the acquisition of Suzhou Abcarta to enrich its business lines in this area. Centered on six major therapeutic areas (tumor, infection, digestion and metabolism, reproduction, cardiovascular, and central nervous system), Fosun Pharma has formed a cross-methodological product portfolio as well as a matrix R&D thinking that expands to different disease fields under the same methodology.

Strictly observes CSR and pursues ESG sustainability
Fosun Pharma has always valued sustainable development as an important benchmark of corporate operations and has released corporate social responsibility (CSR) report for 14 consecutive years to show stakeholders the Group’s practices and achievements in the field of social responsibility. Fosun Pharma’s 2020 CSR Report issued in March 2021 won a five-star rating (excellent) by China CSR Report Rating Expert Committee. At the same time, Fosun Pharma continued to improve its ESG management level and promote sustainable ESG development. The MSCI ESG rating of Fosun Pharma has been upgraded from BB to BBB.

Wu Yifang, Chairman and CEO of Fosun Pharma, said, “Given the pandemic entered a new phase of normalization, Fosun Pharma continued to promote innovation and transformation, as well as the comprehensive globalization capacity. In 2021, we achieved steady financial performance growth and continued to optimize our revenue structure. Focusing on pandemic prevention and control, Fosun Pharma has accelerated the technological innovation of anti-pandemic related products to ensure the supply of relevant materials and strategic products. Looking forward, Fosun Pharma will continue to adhere to its 4IN (Innovation, Internationalization, Integration and Intelligentization) strategy, actively deploy new technologies and products around unmet needs in therapeutic areas, connect with outstanding scientific talents from all over the world through in-house R&D, co-development, in-licensing and incubation, so as to promote the development and implementation of innovative technologies and products. At the same time, based on the existing advantages of medical resources and the Internet platform, Fosun Pharma will actively explore the integrated service model of online and offline, promoting the transformation of online healthcare.”

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About Fosun Pharma
Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group deep-rooted in China. Fosun Pharma directly operates businesses including pharmaceutical manufacturing, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business.

Fosun Pharma is patient-centered and clinical needs-oriented. The company enriches its innovative product pipeline through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma has formed technological platforms for innovative small molecule drugs, antibody drugs, and cell therapy with a focus on key disease areas including oncology and immunomodulation, metabolism and digestive system, and central nervous system. Fosun Pharma also vigorously explores cutting-edge technologies, such as RNA, oncolytic viruses, gene therapy and PROTAC, to enhance its innovation capabilities.

Guided by the 4IN strategy (Innovation, Internationalization, Integration, and Intelligentization), Fosun Pharma will uphold the development model of “innovation transformation, integrated operation, and steady growth”, with the mission of creating shareholder values as well as promoting the global networks through strengthening its innovative R&D and in-licensing ability and enriching its product pipelines. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global mainstream medical and health market.

For more information, please visit our official website: www.fosunpharma.com.

Fosun Pharma Forward-looking statements
This press release contains forward-looking statements. All statements other than statements of historical fact contained in this press release, including, without limitation, the discussions of Fosun Pharma’s business strategies and expectations concerning future operations, margins, profitability, liquidity and capital resources, the future development of Fosun Pharma’s industry and the future development of the general economy of Fosun Pharma’s key markets and any statements preceded by, followed by or that include words and expressions such as “expect”, “seek”, “believe”, “plan”, “intend”, “estimate”, “project”, “anticipate”, “may”, “will”, “would” and “could” or similar words or statements, as they relate to Fosun Pharma’s or its management, are intended to identify forward-looking statements. These statements are subject to certain known and unknown risks, uncertainties and assumptions, which may cause Fosun Pharma’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Accordingly, you should not place undue reliance on any forward-looking information. Subject to the requirements of applicable laws, rules and regulations, Fosun Pharma does not have any and undertakes no obligation to update or otherwise revise the forward- looking statements in this press release, whether as a result of new information, future events or developments or otherwise. In this press release, statements of or references to Fosun Pharma’s intentions are made as of the date of this press release. Any such intentions may change in light of future developments. All forward-looking statements contained in this press release are qualified by reference to the cautionary statements set out above.

To Produce Low-cost, Generic Version of Pfizer’s Oral COVID-19 Treatment nirmatrelvir In Combination With ritonavir For Supply in 95 Low- and Middle-income Countries

SHANGHAI CHINA, March 18, 2022—Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma” or “Group”; Stock Code: 600196.SH, 02196.HK) announced that Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (“‘Fosun Pharmaceutical Industrial”), a subsidiary company of Fosun Pharma, has signed a sublicense agreement with the Medicines Patent Pool (MPP), to manufacture the generic version of Pfizer’s oral COVID-19 treatment nirmatrelvir, which co-packaged with a low dose of ritonavir, can be supplied in 95 low- and middle-income countries (LMICs) comprising approximately 53% of the world’s population.

According to the sublicense agreement, MPP offered a non-exclusive sublicense to Fosun Pharmaceutical Industrial to produce the active pharmaceutical ingredient nirmatrelvir and a generic version of the finished drug itself, nirmatrelvir co-packaged with ritonavir. The manufacturing facilities for the related product under this sublicense are subject to approval by a strict regulatory authority (SRA) or pre-qualified by the World Health Organization (WHO).

“We are glad to reach an agreement with MPP to jointly commit to increasing the global access of COVID-19 antiviral medicines.” said Wu Yifang, Chairman and CEO of Fosun Pharma. “As a company with strong social responsibility, Fosun Pharma always takes innovation as a core driving force in our development. With our global footprints, we are committed to addressing unmet clinical needs and improving the accessibility and affordability of COVID-19 treatments in low- and-middle-income countries worldwide. We will continue to contribute to the global pandemic response on COVID-19 and to help save more lives.”

The nirmatrelvir tablets and ritonavir tablets combination is a co-packaged oral COVID-19 treatment for adults with mild to moderate COVID-19 with high-risk factors for progression to severe diseases. Nirmatrelvir (tablets) (PF-07321332) is a SARS-CoV-2 main protease（Mpro，also known as 3CL protease) inhibitor, and ritonavir, an HIV-1 protease inhibitor and CYP3A inhibitor. Co-administration nirmatrelvir with a low dose of ritonavir helps slow the metabolism, or breakdown of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.

In December 2021, the co-packaged product of nirmatrelvir and ritonavir (under the brand PAXLOVIDTM) from Pfizer was authorized emergency use authorization by the US Food and Drug Administration. It was also authorized conditional approval by the European Medicines Agency in January 2022, fast-track approval by the Japanese Ministry of Health, Labour and Welfare in February 2022, and emergency conditional approval by the National Medical Products Administration of China in February 2022. The drug has now approved for emergency use or conditional authorization in more than 50 countries.

As an innovation-driven international healthcare group in China, Fosun Pharma implements its internationalization strategy in terms of innovative R&D, BD, production, operation, and commercialization. At the same time, Fosun Pharma accelerates the international quality system certification of its manufacturing sites, and enhances its international commercialization capabilities to further expand the international market. After 15 years’ operation in Africa, Fosun Pharma has built a comprehensive distribution network in 35 English and French-speaking Africa countries.

In January 2022, Fosun Pharma signed sublicense agreement with MPP to produce low-cost versions of COVID-19 antiviral medication molnupiravir (MK-4482 and EIDD-2801) for supply in 105 low- and-middle-income countries to help make the anticipated treatments rapidly available in LMICs so as to help end this pandemic for the world.

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About Fosun Pharma
Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (“Fosun Pharma”; stock code: 600196.SH, 02196.HK) is a leading innovation-driven international healthcare group in China. Fosun Pharma strategically operates businesses in the pharmaceutical and health industry, including pharmaceutical manufacturing, medical devices and medical diagnosis, and healthcare services. Through equity participation in Sinopharm Co., Ltd., Fosun Pharma’s business extends to pharmaceutical distribution and retail.
Fosun Pharma takes pharmaceutical manufacturing as its core business and sticks to innovative research and development. Through in-house R&D, co-development, in-licensing and incubation, Fosun Pharma has established platforms for small molecule innovative drugs, antibody drugs and cell therapy, focusing on major therapeutic areas, including oncology, immunology, the “4 hypers” (hypertension, hyperlipidemia, hyperglycemia and hyperuricemia) and their complications, as well as central nervous system. In the meantime, Fosun Pharma keeps close track of cutting-edge technologies, such as targeted protein degradation, RNA, oncolytic virus and gene therapy to enhance its innovation ability.
Looking forward, under guidance of 4IN strategy (Innovation, Internationalization, Integration and Intelligentization), Fosun Pharma practices innovation and transformation, integrated operation and steady development, as well as the concept of sustainable development. Fosun Pharma is committed to becoming a first-class enterprise in the global mainstream healthcare industry.
For more information, please visit: www.fosunpharma.com

Fosun Pharma Forward-looking statements
This press release contains forward-looking statements. All statements other than statements of historical fact contained in this press release, including, without limitation, the discussions of  Fosun Pharma’s business strategies and expectations concerning future operations, margins, profitability, liquidity and capital resources, the future development of Fosun Pharma’s industry and the future development of the general economy of Fosun Pharma’s key markets and any statements preceded by, followed by or that include words and expressions such as “expect”, “seek”, “believe”, “plan”, “intend”, “estimate”, “project”, “anticipate”, “may”, “will”, “would” and “could” or similar words or statements, as they relate to Fosun Pharma’s or its management, are intended to identify forward-looking statements. These statements are subject to certain known and unknown risks, uncertainties and assumptions, which may cause Fosun Pharma’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. Accordingly, you should not place undue reliance on any forward-looking information. Subject to the requirements of applicable laws, rules and regulations, Fosun Pharma does not have any and undertakes no obligation to update or otherwise revise the forward- looking statements in this press release, whether as a result of new information, future events or developments or otherwise. In this press release, statements of or references to Fosun Pharma’s intentions are made as of the date of this press release. Any such intentions may change in light of future developments. All forward-looking statements contained in this press release are qualified by reference to the cautionary statements set out above.

The National Children’s Cancer Society (NCCS) secured a large quantity of Voriconazole, a drug used to treat fungal infections, for a hospital in Guatemala thanks to support from Fosun Pharma USA Inc., a new partner of the NCCS’ Michele Hertlein Global Outreach Program.

Through the Michele Hertlein Global Outreach Program, the NCCS works with pharmaceutical companies to distribute donated cancer treatment drugs and medical supplies worldwide. Upon hearing that a facility in Guatemala was in urgent need of Voriconazole to treat infections in patients, the NCCS reached out to partners. Fosun Pharma assisted with the request, and 1,680 vials of Voriconazole were sent to the hospital at no charge — saving the facility nearly $134,000 in costs.

Fosun Pharma USA Inc. is a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co. Ltd., a leading innovation-driven global pharmaceutical and healthcare group. “We believe in Caring for Life by donating lifesaving drugs to children around the world. We are proud to be a partner of NCCS as they are a great global outreach organization who makes a difference in children’s lives by supplying critically needed drugs,” said Lily Zou, CEO of Fosun Pharma USA.

Fungal infections are a common side effect of chemotherapy treatment due to the impact on immune cells and other infection barriers in the body. If left untreated, these infections can become life-threatening. The NCCS and the hospital in Guatemala are thankful that Fosun Pharma provided desperately needed help.

“We are more than grateful for everything you are doing to save the lives of our patients. And as always, all our admiration and gratitude for having managed to obtain this donation without sparing any effort until it is achieved,” said Sara, the NCCS contact at the facility.

Approximately 170,000 kids with cancer outside of the United States have received lifesaving treatment from the Michele Hertlein Global Outreach Program. Since the inception of the program, the NCCS has distributed more than $416 million in donated medical products to 65 children’s hospitals and clinics in 42 countries thanks to the generous support of the program’s corporate partners and donations.

The Michele Hertlein Global Outreach Program currently serves children in need — at absolutely no cost to the family — in El Salvador, Guatemala, Haiti, Honduras, Kyrgyzstan, Lebanon, Morocco, Nicaragua, Zimbabwe and various countries in Africa.

The National Children’s Cancer Society (NCCS), headquartered in St. Louis, Mo., is a not-for-profit organization providing support to families making their way through the daunting world of childhood cancer and survivorship. With over 30 years of experience serving more than 45,000 children, the NCCS is able to take a “no matter what” approach to help families stay strong, stay positive and stay together. The NCCS has been recognized as a Better Business Bureau Accredited Charity and earned a GuideStar Platinum Seal of Transparency. For more information, call 314-241-1600, visit theNCCS.org or follow on Facebook, Twitter and Instagram.

Fosun Pharma USA Inc. was founded in 2017 and continually works to enhance its portfolio of specialty pharmaceutical products and to build a pipeline of both innovative and generic pharmaceutical drugs. With strategic manufacturing partnerships around the world, Fosun Pharma USA Inc. delivers high-quality products that comply with international standards.

Caring for others and contributing to society are important components of our corporate responsibility. Our parent company, Shanghai Fosun Pharmaceutical (Group) Co. Ltd., partnered with Medicines for Malaria Venture (MMV), has supplied 100 million doses of injectable artesunate to global markets, which are estimated to have cured more than 20 million patients with malaria. For more information, call 1-866-611-8638, visit fosunpharmausa.com or follow on LinkedIn.