（编辑 任世碧） 证券日报网讯 富士莱11月25日在互动平台回答投资者提问时表示，截至目前，公司已收到江苏省药品 监督管理局的药品GMP符合性检查结果告知书，获悉公司原料药甲磺酸阿帕替尼符合药品GMP，为后 续的商业化奠定坚实的基础。 ...

Core Viewpoint - Heng Rui Pharmaceutical is transitioning from its previous identity as a "generic drug king" to focus on innovative drugs, showing significant growth in revenue and net profit in its recent quarterly report, driven by the success of innovative drugs and major international collaborations [1][3]. Financial Performance - For the first three quarters of 2025, Heng Rui reported a revenue of 23.188 billion yuan, a year-on-year increase of 14.85%, and a net profit of 5.751 billion yuan, up 24.5% [3][4]. - The operating cash flow for the period surged by 98.68% to 9.11 billion yuan, attributed to increased sales and cash from overseas licensing agreements [2][4]. Innovation and R&D - Heng Rui's R&D expenses reached 4.945 billion yuan in the first three quarters, with total R&D investment exceeding 50 billion yuan [4][5]. - The company has 24 approved innovative drugs and 5 new drugs, with 13 new drug applications accepted by the National Medical Products Administration in the first three quarters [5]. Market Position and Competition - Heng Rui lost its title as "pharmaceutical king" in A-shares to BeiGene, with a market cap lagging by approximately 16.8 billion yuan as of late October 2023 [6]. - The competition between Heng Rui and BeiGene highlights differing strategies, with Heng Rui focusing on a "fast-follow" approach while BeiGene emphasizes original innovation [6]. Impact of Price Cuts and Market Challenges - The introduction of centralized procurement has significantly impacted Heng Rui's traditional generic drug business, leading to a sharp decline in revenue from key products [7][9]. - The company's revenue fell for the first time in 2021, with a notable drop in net profit due to price reductions on key drugs after entering the medical insurance list [9][10]. Internationalization Strategy - Heng Rui's international revenue has remained low, with overseas sales not exceeding 800 million yuan from 2017 to 2024, contrasting sharply with BeiGene's international success [11]. - The company is now pursuing a business development (BD) strategy to enhance its international presence, achieving significant licensing deals in 2023 [12][13]. Recent Developments - In 2023, Heng Rui completed five overseas licensing deals worth over $4 billion, including a notable agreement with GlaxoSmithKline for global rights to certain projects [12][13]. - The increase in contract liabilities indicates a substantial influx of cash from overseas licensing agreements, which may positively impact future performance [13][14].

Group 1 - The core point of the article is that Fujifilm (富士莱) has announced its collaboration with Hengrui Medicine (恒瑞医药) on an active pharmaceutical ingredient (API) project, which includes Eribulin and Apatinib Mesylate [1] Group 2 - The collaboration focuses on the development of specific APIs, indicating a strategic partnership in the pharmaceutical sector [1] - The mention of Eribulin and Apatinib Mesylate highlights the company's involvement in oncology-related drug development [1]

Group 1 - The core point of the article is that Fujifilm (301258.SZ) has announced a collaboration with Hengrui Medicine on an active pharmaceutical ingredient project involving Eriocitrin and Apatinib Mesylate [1] Group 2 - The collaboration focuses on the development of raw materials for pharmaceutical products [1] - The specific drugs mentioned in the partnership are Eriocitrin and Apatinib Mesylate, which are significant in the pharmaceutical industry [1]

Core Viewpoint - Hengrui Medicine has successfully listed on the Hong Kong Stock Exchange, marking the largest pharmaceutical IPO in Hong Kong in nearly five years, with significant international investor interest and a total subscription amount of approximately HKD 41.31 billion, representing 41.77% of the total issuance scale [1][5][21]. Group 1: Company Overview - Hengrui Medicine, a leader in China's innovative pharmaceutical sector, has transformed from a small local manufacturer to a global player, now ranked among the top 50 pharmaceutical companies worldwide [4][10]. - The company has a rich history of over 55 years, witnessing significant growth and development in the pharmaceutical industry [4][22]. Group 2: Historical Development - From 1970 to 2003, Hengrui Medicine began as a small pharmaceutical factory, focusing on basic medicines, and achieved its first major success with the launch of the cancer drug Ifosfamide in 1995, leading to its status as a billion-yuan sales enterprise [5][6]. - Between 2004 and 2017, the company accelerated its transformation by establishing a research center in Shanghai and entering the high-value innovative drug development sector, achieving FDA certification for its products [6][7]. - From 2018 to 2022, Hengrui increased its R&D investment significantly, reaching CNY 6.346 billion in 2022, which accounted for 29.83% of its sales revenue, marking a historical high for the company [7][8]. Group 3: Recent Developments - Since 2023, Hengrui has shifted its focus from generic drugs to innovative drug development, with projected sales revenue from innovative drugs reaching CNY 13.892 billion in 2024, a year-on-year increase of 30.60% [9][12]. - The company has also engaged in 14 innovative drug licensing transactions since 2018, leading the domestic pharmaceutical industry in this area [9][12]. Group 4: Global Expansion Strategy - Hengrui is actively pursuing international markets, having initiated over 20 overseas clinical trials in regions such as the US, Europe, and Japan, and has completed 9 business development transactions in the past three years, with a cumulative transaction value of approximately USD 14 billion [18][21]. - The recent listing on the Hong Kong Stock Exchange is a strategic move to enhance its global brand influence and attract international investors, facilitating further international collaborations and business expansion [21][22].

Investment Rating - The report maintains an investment rating of "Outperform the Market - A" for the biopharmaceutical sector [4]. Core Insights - The report highlights that Heng Rui Medicine has updated its innovative drug pipeline, entering a harvest period with 19 Class 1 innovative drugs approved for market, 11 in NDA stage, and 16 in Phase 3 clinical trials [2][18]. Summary by Sections Weekly New Drug Market Review - From March 31 to April 4, 2025, the top five companies in the new drug sector by stock price increase were: Hai Chuang Pharmaceutical (20.74%), Yi Ming An Ke (17.89%), Jia He Bio (15.20%), Kang Fang Bio (15.15%), and Mai Wei Bio (12.25%). The top five companies with the largest declines were: Chuang Sheng Group (-24.18%), Teng Sheng Bo Yao (-19.92%), He Bo Pharmaceutical (-17.76%), Mai Bo Pharmaceutical (-17.19%), and Ge Li Pharmaceutical (-12.75%) [1][14]. Key Analysis of the New Drug Industry - Heng Rui Medicine's 2024 annual report reveals its latest research pipeline as of March 2025, with 19 Class 1 innovative drugs approved, 11 in NDA stage, and 16 in Phase 3 clinical trials. The approved drugs include various treatments across oncology, metabolism, immunology, and cardiovascular fields [2][18][20]. New Drug Approvals and Acceptance - In the week, 10 new drugs or new indications were approved for market, 37 new drugs received IND approval, 19 new drugs had IND applications accepted, and 5 new drugs had NDA applications accepted [9][22]. Domestic New Drug Industry Focus - Key highlights include Heng Rui Medicine's JAK1 inhibitor, Aima Xitini (SHR0302), receiving approval for a new indication for adult patients with moderate to severe active rheumatoid arthritis. Additionally, the company has initiated Phase 3 clinical trials for its GLP-1 receptor agonist, HRS-7535, aimed at weight loss [10][30].

Investment Rating - The report maintains an investment rating of "Outperform the Market - A" for the biopharmaceutical sector [4]. Core Insights - The report highlights that Heng Rui Medicine has updated its innovative drug pipeline, entering a harvest period with 19 Class 1 innovative drugs approved for market, 11 in NDA stage, and 16 in Phase 3 clinical trials [2][18]. Summary by Sections Weekly New Drug Market Review - From March 31 to April 4, 2025, the top five companies in the new drug sector by stock price increase were: Hai Chuang Pharmaceutical (20.74%), Yi Ming An Ke (17.89%), Jia He Bio (15.20%), Kang Fang Bio (15.15%), and Mai Wei Bio (12.25%). The top five companies with the largest declines were: Chuang Sheng Group (-24.18%), Teng Sheng Bo Yao (-19.92%), He Bo Pharmaceutical (-17.76%), Mai Bo Pharmaceutical (-17.19%), and Ge Li Pharmaceutical (-12.75%) [1][14]. Key Analysis of the New Drug Industry - Heng Rui Medicine's 2024 annual report reveals its latest research pipeline as of March 2025, with 19 Class 1 innovative drugs approved, 11 in NDA stage, and 16 in Phase 3 clinical trials. The approved drugs include various treatments across multiple therapeutic areas [2][18][21]. New Drug Approvals and Acceptance - In the past week, 10 new drugs or new indications were approved for market, 37 new drugs received IND approval, 19 new drugs had IND applications accepted, and 5 new drugs had NDA applications accepted [22][23]. Domestic New Drug Industry Focus - Key highlights include Heng Rui Medicine's JAK1 inhibitor, Aima Xitini (SHR0302), receiving approval for a new indication for adult patients with moderate to severe active rheumatoid arthritis. Additionally, the company has initiated Phase 3 clinical trials for its GLP-1 receptor agonist, HRS-7535, aimed at weight loss [30][31].

Core Viewpoint - Heng Rui Medicine has received a Complete Response Letter (CRL) from the FDA regarding its application for the combination of Carrelizumab and Apatinib for the first-line treatment of unresectable or metastatic hepatocellular carcinoma, indicating further responses are needed regarding production site inspections [1][2] Group 1: FDA Response and Approval Process - The FDA's CRL indicates that there are deficiencies and risks that need to be addressed, but it does not specify the exact reasons for the delay [1] - Heng Rui Medicine received its first CRL in May 2024, citing production site inspection deficiencies and travel restrictions affecting necessary biological research monitoring [1] - The company has actively responded to the FDA's new improvement requests and is in close communication with the agency [2] Group 2: Clinical Research and Market Context - The application is based on positive results from an international multicenter Phase III clinical study (CARES-310), which has already led to approval in China for the same treatment indication in 2023 [2] - The combination of Carrelizumab and Apatinib has shown the longest median overall survival (mOS) data among approved treatment options for unresectable or metastatic hepatocellular carcinoma [2]