2024-03-27

Fosun Pharma Announces 2023 Annual Results: Continues to Promote Innovation Transformation and Enhances Global Operational Capabilities to Accelerate the Localization of Innovative Products

(March 27 2024, Shanghai, China)On March 26, 2024,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, announced its annual results for the year ended 31 December 2023 (“the Reporting Period”). During the Reporting Period, Fosun Pharma adhered to innovation transformation and continued to enhance its global operational capabilities to accelerate the localization of innovative products, achieving revenue of RMB41.4billion, an increase of 12.43% YoY after excluding COVID-related products.


Since the establishment 30 years ago, Fosun Pharma has developed in line with the high-quality development of China’s pharmaceutical and healthcare industry with a focus on patients and scientific and technological innovation. To meet the unmet clinical needs, Fosun Pharma has formed a diversified and multi-level innovation models such as independent R&D, cooperative development, license-in, and in-depth incubation,focusing on core therapeutic areas such as tumors (solid tumors and hematologic tumors), immunology, central nervous system, and chronic diseases (liver disease/metabolism/kidney disease), Fosun Pharma accelerated the R&D and launch of innovative technologies and products, and promoted high-quality development of the company.


Continues to promote innovation transformation, revenue from innovative products maintains rapid growth


In 2023, Fosun Pharma continued to promote innovation transformation, a total of 8 innovative indications of 6 innovative drugs were approved for launch, and revenue from key innovative products maintained rapid growth, including Han Si Zhuang(serplulimab injection), trastuzumab injection (trade name in Chinese mainland: Han Qu You), and Su Ke Xin (avatrombopag maleate tablets). During the Reporting Period, Han Si Zhuang achieved revenue of RMB1.1 billion, an increase of 230.20% YoY, Han Qu You grew by 58.19% YoY to RMB2.7 billion, and the revenue from Su Ke Xin grew by 19.67% YoY to RMB0.9 billion.


During the Reporting Period, Fosun Pharma's first self-developed biopharmaceutical innovative drug, Han Si Zhuang, has been successively approved for two indications, Extensive-Stage Small Cell Lung Cancer (ES-SCLC) and esophageal squamous cell carcinoma (ESCC) in Chinese mainland,becoming the world's first monoclonal antibody drug targeting PD-1 approved for the first-line treatment of extensive small cell lung cancer (ES-SCLC). Up to now, Han Si Zhuang has been approved for four indications, benefiting more than 60,000 Chinese patients. In addition, Serplulimab Injection had been approved for treatment of extensive-stage small cell lung cancer (ESSCLC) by the Indonesian Food and Drugs Authority (BPOM). It was the first time for this product approved for launch in overseas market, making it the first Chinese PD-1 monoclonal antibody drug approved for launch in Southeast Asia.


Yi Kai Da (ejilunsai injection) is the first CAR-T cell therapy product approved for domestic launch from Fosun Kite, a joint venture. In June 2023, the new second-line indication of Yi Kai Da was approved in Chinese mainland, which will benefit more patients with tumor that is refractory to first-line immunochemotherapy or relapses. As at the end of the Reporting Period, benefitting over 600 patients with lymphoma in total, Yi Kai Da has been included in over 100 urban customized commercial health insurances and over 75 commercial insurances, while the number of treatment centers on record exceeded 160, covering more than 25 provinces and municipalities across China. In January 2024, Yi Kai Da created customized innovative insurance payment by therapeutic value solutions, exploring a new path of for the payment mode of high value innovative drugs in China.


During the Reporting Period, 4 products exclusively commercialized by Fosun Pharma were approved for launch in Chinese mainland, including Bei Wen (倍稳) (keverprazan hydrochloride tablets), the first potassium ion competitive acid blocker (P-CAB) independently developed in China , Pei Jin (珮金) (telpegfilgrastim injection), a long-lasting recombinant human granulocyte colony-stimulating factor product, Pang Bi Fu (旁必福) (etelcalcetide hydrochloride injection), the new generation of calcimimetic, and Yi Xin Tan (sacubitril valsartan sodium tablets), an innovative crystalline drug for heart failure and hypertension.


Continues to optimize R&D system and accelerates the progress of pipelines under development


Fosun Pharma continued to optimize its R&D system. With the improving R&D strategies, the Group focused on developing the four core technology platforms, namely small molecule, antibody/ADC, RNA and cell therapy, creating an open and global innovative R&D system, actively exploring cutting-edge technologies such as cancer vaccine and AI drug R&D to continuously enhance its core R&D capabilities and pipeline value, and facilitate the R&D and commercialization of more FIC (First-in-class) and BIC (Best-in-class) products.


In 2023, total R&D expenditures of the Group amounted to RMB5,937 million, representing a year-on-year increase of 0.88%. In particular, the R&D expenses amounted to RMB4,346 million, representing a year-on-year increase of 1.02%. The R&D expenditures in pharmaceutical manufacturing segment amounted to RMB5,172 million, representing a year-on-year increase of 1.47%. There are over 70 major pipeline projects on innovative drugs and biosimilars (calculated by indications).


In 2023, Fosun Pharma accelerated the development of pipelines under development. 5 products with a total of 7 indications independently developed, co-developed and license-in by the Group, had entered the pre-launch approval stage. Among them, the marketing authorization application (MAA) of Serplulimab Injection (PD-1 inhibitor), a self-developed biopharmaceutical innovative drug of the Group, in the EU had been accepted, and the New Drug Application (NDA) of the product had also been accepted by the National Medical Products Administration (NMPA) for the fifth indication of first-line treatment of non-squamous non-small cell lung cancer (nsNSCLC). The biologics license application (BLA) of Fosun Pharma’s self-developed trastuzumab injection (trade name in Chinese mainland: Han Qu You) had been accepted by the U.S. FDA for the treatment of breast cancer, which is expected to become the first domestic biosimilar approved in China, the EU and the United States, thus further covering the mainstream biopharmaceutical markets in Europe and the United States. The NDA of FCN-437c, an innovative small molecule CDK4/6 inhibitor that Fosun Pharma has independent intellectual property rights, was also accepted by the NMPA in November 2023.


The phase III clinical research of FS-1502 (recombinant HER2 humanized monoclonal antibody-monomethyl auristatin F conjugate for injection), an innovative antibody drug conjugate originally licensed-in and subsequently independently developed by Fosun Pharma, for the treatment of HER2 positive locally advanced or metastatic breast cancer that cannot be removed through surgery has commenced in Chinese mainland.


During the Reporting Period, Fosun Pharma continued to promote the R&D and the industrialization of vaccines in its pipeline. In April 2023, the 13-valent pneumococcal conjugate vaccine, which is independently developed by the Group, completed patient enrollment for phase III clinical trial. In March 2024, the rabies vaccine (Vero cells) for human use (freeze dried) independently developed by the Group was approved for launch in China.


In addition, the NDAs of several pipeline products in Chinese mainland, including DaxibotulinumtoxinA botulinum toxin (project code: RT002), tenapanor hydrochloride tablets (project code: Tenapanor), and the injectable product Profhilo (sodium hyaluronate solution for injection) were accepted by the NMPA.


Continues to strengthen global operational capabilities and accelerate the localization of innovative products


As a global pharmaceutical and healthcare industry group, Fosun Pharma continues to uphold the internationalization strategy in multiple dimensions, such as innovative R&D, two-way license, production and operations as well as commercialization to enhance operational efficiency and strengthen global market layout, while covering major overseas markets, including the United States, Europe, Africa, India, and Southeast Asia. As at the end of the Reporting Period, the Group had formed an overseas commercialization team of approximately 1,000 employees.


During the Reporting Period, Fosun Pharma has built an innovative drug commercialization team in the U.S. market, and initiated the preparatory work for the commercialization ofSerplulimab Injection and the preliminary layout for the license-in of innovative products. In emerging markets such as Africa, the Group has set up 5 regional distribution centers. Gland Pharma, a subsidiary of Fosun Pharma, completed the acquisition of Cenexi, a European CDMO company, so as to strategically establish its CDMO business presence in the European market and build up local manufacturing capabilities in Europe and expand customer base further.


Fosun Pharma actively introduces leading international technologies and products into the Chinese market to benefit more Chinese patients. In December 2023, CML (Chindex Medical Limited), Fosun Pharma’s subsidiary, and Insightec formally signed a cooperation agreement to establish a joint venturein China. This joint venture is focused on commercializing and developing clinical efforts of magnetic resonance-guided focused ultrasound treatment system for neurological diseases (MRgFus brain therapy system) in Mainland China, Hong Kong S.A.R and Macao S.A.R to improve the lives of patient living with Parkinson's disease (PD) and essential tremor (ET), working to help them regain their quality life and wellbeing. MRgFus brain therapy system uses magnetic resonance imaging to achieve non-invasive treatment of various neurological diseases in the human brain with millimeter-level precision. It is currently the most cutting-edge non-invasive transcranial treatment technology.


During the Reporting Period, the localization process of Da Vinci Surgical Robot, the world's leading surgical robot, has been accelerated, with a total of 55 units installed in China and Hong Kong. In June 2023,themedical device registration of the domestic Da Vinci Xi system (thoracic and abdominal endoscopy surgical control system) was approved by the NMPA, which can be applied in endoscopic surgeries in urology, general surgery, obstetrics and gynecology, thoracic surgery etc. In December 2023, the first domestically-manufactured Da Vinci Surgical Robot was officially installed in the Cancer Center Gansu Hospital of Sun Yat-sen University.


In March 2024, the localization process of Intuitive Fosun’s robotic surgical system achieved further progress with the Ion Bronchial Navigation Operation Control System (Ion System) being approved by the NMPA. The Ion System uses the flexible robots with shape sensing technology to perform precise diagnosis and treatment of peripheral lung lesions through the bronchus. The implementation of the Ion System in China will help more lung cancer patients obtain early diagnosis and treatment in a more minimally invasive way.


Practices ESG concepts and promotes sustainable development


Fosun Pharma officially released its first ESG and Sustainability Report in 2024. Following fifteen consecutive years of releasing a CSR report and three consecutive years of releasing an ESG report, the ESG and Sustainability Report marks a new milestone for Fosun Pharma to promote the sustainable development strategy and demonstrate its practices and achievements in environmental protection, social responsibility and corporate governance to stakeholders.


In 2023, Fosun Pharma accelerated the launch of new products. With a number of innovative drugs and new indications been included in the National Medical Insurance Drugs Catalogue, the accessibility and affordability of innovative drugs have been further improved. In the field of rare diseases, Fosun Pharma accelerated the research and development of rare disease drugs and urgently needed clinical drugs. The independently developed and produced human interferon γ for injection (trade name: CLONGAMMA) continued to bring new hope for treatment to children with rare diseases such as chronic granulomatous disease. As of now, Fosun Pharma has 4 drugs on the market to cure rare diseases such as chronic granulomatous disease, infantile spasms, and idiopathic pulmonary hypertension, and has 10 rare disease drugs under development.


Rooted in China, with a global presence. Fosun Pharma also gives full play to its advantages to help solve the problem of drug accessibility in developing countries. In the field of anti-malaria, Artesun (Artesunate for injection), an innovative drug independently developed by Fosun Pharma, has become a first-line drug recommended by the World Health Organization for the treatment of severe malaria, and has treated more than 68 million severe malaria patients around the world, helping to effectively reduce the mortality of severe malaria. In June 2023, the second-generation artesunate for injection Argesun®independently developed by Fosun Pharma, becoming the first injectable artesunate presented with a single solvent system passing WHO prequalification, which will enhance the accessibility of high-quality innovative antimalarial drugs and save more lives.


In 2023, Fosun Pharma was listed on Fortune's All-Star list of the most-admired Chinese companies for its outstanding performance in the fields of continuous innovation and improving drug accessibility. It was also been new winner of Deloitte's 2023 China Best Managed Companies. During the Reporting Period, Fosun Pharmaretained an A in MSCI ESG rating and received an A– in HSI ESG rating, and was selected into the Hang Seng (China A) Corporate Sustainability Benchmark Index, the Hang Seng (China A) Corporate Sustainability Index and the Hang Seng (Mainland and HK) Corporate Sustainability Index.


“Since its establishment three decades ago, Fosun Pharma has always been patient-centered, focused on unmet clinical needs, continued to increase investment in innovation, and efficiently promoted the R&D and commercialization of world-leading technologies and innovative products, and is committed to becoming a first-class enterprise in the global pharmaceutical and healthcare markets.”Wu Yifang, Chairman of Fosun Pharma said, “Looking forward, Fosun Pharma will adhere to its technology-driven approach, maintain a steady process on global presence, focus on core therapeutic areas such as tumors, immunology, central nervous system, and chronic diseases, actively explore and promote the transformation of original innovation, leading the high-quality development of the healthcare industry.”


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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. Fosun Pharma directly operates businesses including pharmaceuticals, 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 continuously enriches its innovative product pipeline through independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma improves the research and clinical development capabilities of FIC (First-in-class) and BIC (Best-in-class) new drugs as well as accelerates the R&D and launch of innovative technologies and products. Fosun Pharma’s innovative products mainly covered core therapeutic areas such as tumors (solid tumors and hematologic tumors), immunology, central nervous system, and chronic diseases (liver disease/metabolism/kidney disease).


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 pharmaceutical and healthcare markets.


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