FCN-159

SHANGHAI, Aug. 29, 2023 /PRNewswire/ -- On August 29, 2023, Shanghai Fosun Pharmaceutical Co., Ltd.* (Stock Code: 600196.SH; 02196.HK) announced its 2023 Interim Results for the first half of 2023. (the "Reporting Period"). During the Reporting Period, Fosun Pharma achieved revenue of RMB21.395 billion; the net profit attributable to shareholders of the listed company was RMB1.777 billion, with a period-on-period growth of 15.74%. As 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 Group Co. Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. The pharmaceuticals business is the core business of Fosun Pharma. For the first half of 2023, pharmaceuticals business achieved revenue of RMB15.995 billion, with a period-on-period growth of 11.64%. 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). Over the years, through diversified and multi-level innovation models such as independent R&D, cooperative development, license-in, and in-depth incubation, Fosun Pharma accelerated the R&D and launch of innovative technologies and products, further expanded its innovative product portfolio, and continued to bring new momentum to performance growth. Adheres to open innovation strategy and speeds up the launch of new products In the first half of 2023, a number of innovative products and indications self-developed and co-developed by Fosun Pharma were approved for launch, further expanding the innovative product portfolio, contributing to the continuous optimization of product structure and maintaining rapid growth of revenue from innovative products. Among them, revenue from Han Si Zhuang which was approved for launch in March 2022 achieved RMB556 million during the Reporting Period, entering the "speeding up period" of commercialization. Revenue from Han Qu You increased 57.1% period-on-period, while revenue from Su Ke Xin increased 32.7% period-on-period. Han Si Zhuang is the first self-developed biopharmaceutical innovative drug of Fosun Pharma, as well as the world's first monoclonal antibody drug targeting PD-1 approved for the first-line treatment of extensive small cell lung cancer, which has been approved for three indications including the treatment of Microsatellite Instability-high (MSI-H) solid tumors, Squamous Non-small Cell Lung Cancer (sqNSCLC) and Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The NDA for fourth indication for first-line treatment of esophageal squamous cell carcinoma (ESCC) has also been accepted in Chinese Mainland. As at the end of Reporting Period, Han Si Zhuang has completed the online bidding in 29 provinces/ autonomous regions/ municipalities in Chinese Mainland and was included in the customized commercial insurance catalogue in various cities, including Shanghai, Ningbo, Zhuhai, benefiting more than 34,000 Chinese patients. During the Reporting Period, Yi Kai Da (ejilunsai injection), the domestic first CAR-T cell therapy product, obtained new approval for second-line indication in Chinese Mainland (for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line immunochemotherapy or that relapses within 12 months of first-line immunochemotherapy (r/r LBCL)) to benefit more lymphoma patients in China. Fosun Pharma adheres to an open innovation strategy and actively expands its pipelines through BD. During the Reporting Period, Bei Wen (Keverprazan Hydrochloride tablets), the first potassium ion competitive acid blocker (P-CAB) independently developed in China and exclusively commercialized by Fosun Pharma, Pei Jin (Telpegfilgrastim injection), the long-lasting recombinant human granulocyte colony-stimulating factor product, and Pang Bi Fu (Etelcalcetide Hydrochloride injection), the newgeneration of calcimimetic, were approved for launch in Chinese Mainland, further enriching its product portfolio in the innovative drugs field. Meanwhile, Fosun Pharma has been making rapid progress in its pipeline, with many products successively entered the critical clinical/approval stage. Up to now, the phase III clinical research of MEK1/2 selective inhibitor FCN-159 self-developed by Fosun Pharma for the treatment of neurofibromatosis type I in adults has commenced in Chinese Mainland. Two indications of ongoing projects have been included in the breakthrough therapy drug program; the enrollment of the phase III clinical trial of self-developed 13-valent pneumococcal conjugate vaccines (multivalent combinations) has been completed. In addition, the NDA for several pipeline drugs, including DaxibotulinumtoxinA (RT002) and Tenapanor, has been accepted in Chinese Mainland. Continues to optimize the R&D system and improve R&D efficiency Fosun Pharma continued to optimize its R&D system. Under an increasingly refined R&D strategy, it has promoted the layout of four core technology platforms such as small molecules, antibody/ADC, RNA and cell therapy, and continues to promote the R&D and launch process of various innovative products. In the first half of 2023, Fosun Pharma continued to increase its expenditures in innovative R&D, with a total R&D expenditures of RMB 2.88 billion during the Reporting Period, with a period-on-period growth of 19.77%, among which, the R&D expenses amounted to RMB 2.13 billion, with a period-on-period growth of RMB 0.31 billion or 16.80%. The R&D expenditures in the pharmaceutical manufacturing business amounted to RMB 2.52 billion, with a period-on-period growth of 22.16%, and the R&D expenditures in the pharmaceutical manufacturing business accounted for 15.75% of the revenue from the pharmaceutical manufacturing business, among which, the R&D expenses amounted to RMB 1.79 billion, accounting for 11.20% of the revenue from the pharmaceutical manufacturing business. As at the end of the Reporting Period, Fosun Pharma had over 70 major pipeline projects on innovative drugs and self-developed biosimilars. During the Reporting Period, 5 innovative drugs (indications) and 10 generic drugs (indications) were approved for launch; 4 innovative drugs/ biosimilar (indications) and 34 generic drugs (indications) had applied for launch (NDA); 7 innovative drugs/ biosimilar (indications) were approved for clinical trials (IND) in Chinese Mainland. To further strengthen scientific and technological innovation strategy and improve R&D efficiency, during the Reporting Period, Fosun Pharma has established a Scientific Advisory Board (SAB) at the group level, further endeavored to optimize the top-level structure of the innovation, introduced a number of senior scientists and C-level talents, and comprehensively upgraded domestic and overseas capabilities in early R&D, CMC, clinical medicine and clinical operations. At the same time, the Company reorganized its innovative drug project establishment and dynamically evaluated its pipeline value and competitiveness, thereby improving the quality and effectiveness of R&D. Steadily promote the multi-dimensional internationalization of R&D, production and marketing to enhance global operational capabilities While accelerating the development of innovation transformation, 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. Fosun Pharma actively promotes the overseas expansion of high-quality products. The mature generic drug sales team of the Company in the United States has established collaborations with 5 large distributors and 16 group purchasing organizations (GPOs) to promote the sales of preparations products. At the same time, Fosun Pharma has initiated the establishment of an innovative drug team in the United States to advance the commercialization of Serplulimab Injection (PD-1 inhibitor, trade name in China: Han Si Zhuang). As China's first independently developed monoclonal antibody drug approved in both China and Europe, the U.S. biologics license application (BLA) of Trastuzumab for Injection (trade name in China: Han Qu You) has been accepted by the U.S. FDA; the marketing authorization application (MAA) of Serplulimab Injection (PD-1 inhibitor) for the treatment of extensive-stage small cell lung cancer (ES-SCLC) has also been accepted in the European Union. Furthermore, through licensing collaborations with internationally renowned pharmaceutical companies such as Boston Oncology and KGbio, Fosun Pharma is expanding its presence in numerous emerging markets to enhance the accessibility and recognition of its high-quality products in the international market. In emerging markets, with a sales network covering more than 40 countries and regions, Fosun Pharma's pharmaceutical export and distribution business in the African market mainly targets the English-speaking and French-speaking regions of sub-Saharan Africa. During the Reporting Period, the Côte d'Ivoire hub, integrating drug R&D, manufacturing, and logistics distribution, has been constructed, aiming to achieve localized drug manufacturing and supply in Africa. With the purpose of consolidating the foundation for the overseas expansion of preparations products, Fosun Pharma continues to promote the certification of international production quality standards. The second-generation artesunate for injection (Argesun) independently developed by Fosun Pharma passed the WHO Prequalification (WHO PQ), becoming the first artesunate injectable presented with a single solvent system approved by WHO PQ. Gland Pharma, the Indian subsidiary of Fosun Pharma, completed the acquisition of European CDMO company Cenexi, to strategically establish its CDMO business presence in the European market and build up local manufacturing capabilities in Europe. In addition, Fosun Pharma has established a global marketing network combining direct sales and distribution for the medical device business. In the field of professional medical devices, the joint venture company Intuitive Fosun continues to promote the localization of medical devices, helping more Chinese surgeons master the world's leading robotic-assisted surgical technology. During the Reporting Period, the installation volume of the "Da Vinci Surgical System" is 34 units, and the "Thoracoabdominal Endoscopic Surgical Control System" obtained medical device registration approval from the National Medical Products Administration in June 2023, indicating that the locally produced Da Vinci Surgical System will soon be introduced to the public. Building an industry leading ESG system to improve product accessibility and affordability Fosun Pharma has always regarded innovation as the most important social responsibility for its sustainable development. It is committed to improving product accessibility and affordability. As of the end of the Reporting Period, Fosun Pharma has already launched two rare disease or orphan drug products, i.e. Su Ke Xin (Avatrombopag Malate tablets) and Wei Ge Ding (Vigabatrin powder for oral solution), and continuously promoted the construction of rare disease product lines, showing care for the rare disease community through innovative R&D. In addition, as of the end of June 2023, Yi Kai Da (Ejilunsai injection) has been included in over 90 urban customized commercial health insurances and over 60 commercial insurances, while the number of treatment centers on record exceeded 140, covering more than 25 provinces and municipalities across China, benefiting more than 500 lymphoma patients in China. Meanwhile, as one of the world's largest manufacturers of antimalarial drugs, as of the end of the Reporting Period, Fosun Pharma has supplied over 300 million injections of self-developed Argesun injection to the international market. In Africa alone, over 245 million children have benefited from the Seasonal Malaria Chemoprevention Program, which is based on the SPAQ-CO series of drugs, effectively reducing the incidence of malaria among local children. In terms of internal compliance supervision, Fosun Pharma has further strengthened the openness and transparency of the management system. In January 2023, it publicized a number of internal systems on the company's official website, including the " Regulations on Anti-Corruption ", "Provisions on Integrity Administration of Engineering Construction Projects (Trial))" and "Regulations on the Management of Integrity in Practice ", etc., aiming to creating a fair and honest business environment and culture. At the same time, Fosun Pharma continues to improve the ESG (Environmental, Social and Governance) system and improve the overall level of ESG to help maintain its long-term sustainable development. In 2023, Fosun Pharma maintained an A grade rating in MSCI ESG Ratings and an A- rating in HSI ESG, ranking among the top tier in the healthcare industry for pharmaceuticals and biotechnology. It was also selected as a constituent of the Hang Seng (China A) Corporate Sustainability Benchmark Index ("HSCASUSB"), Hang Seng (China A) Corporate Sustainability Index ("HSCASUS"), and Hang Seng (Mainland and HK) Corporate Sustainability Index ("HSMHSUS"). "At present, China's healthcare industry is undergoing a period of accelerated adjustment. Fosun Pharma has maintained its strategic focus in the face of challenges, continued to promote innovation transformation, optimized product structure, adhered to an open innovation strategy and steady internationalization." Wu Yifang, Chairman of Fosun Pharma said, "Looking forward, the company will continue its technology-driven and product-driven approach, with a further expand into therapeutic areas with significant unmet needs. Also, Fosun Pharma will continue to enhance its R&D efficiency, strengthen independent research capabilities, foster external collaborations, and enrich its product pipeline. In addition, the company will focus on improving global operational capabilities, pursuing lean operations, enhancing quality and efficiency, and leveraging digital technology to drive business growth. These endeavors align with Fosun Pharma's vision to contribute to Healthy China and promote better health for families worldwide." 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 Group 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. 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: SOURCE Fosun Pharma