Core Viewpoint - Tian Tan Biological announced the withdrawal of the drug registration application for "Recombinant Human Coagulation Factor VIIa" by its subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. due to the need for additional clinical trial data for pediatric patients under 12 years old [1] Group 1: Company Actions - The product's market authorization application was submitted to the National Medical Products Administration (NMPA) on January 2025 and received an acceptance notice [1] - Following the NMPA's review comments, Chengdu Rongsheng decided to withdraw the drug registration application to supplement the required clinical data [1] - The company plans to resubmit the drug registration application after completing the necessary clinical trials [1] Group 2: Impact on Business - The announcement states that the withdrawal of the drug registration application will not have a significant impact on the company's operating performance [1] - The company must complete the clinical trial data and pass the review and approval processes to achieve production and market sales [1] Group 3: Industry Considerations - The announcement highlights the long-term and uncertain nature of drug development, indicating potential risks for investors [1]

Core Viewpoint - The company reported a decline in revenue and profit for the first nine months of 2025, primarily due to industry policy impacts such as centralized procurement and price adjustments in the national medical insurance drug list [1][2]. Financial Performance - The company recorded revenue of RMB 19.891 billion and a profit attributable to shareholders of RMB 3.511 billion, representing a decrease of 12.3% and 7.1% respectively compared to the same period last year [1]. - The basic earnings per share attributable to shareholders was RMB 0.3072, down 4.1% year-on-year [1]. - The revenue from the pharmaceutical business was RMB 15.450 billion, including licensing fee income of RMB 1.540 billion, which decreased by 17.2% year-on-year [1]. - The raw material products business achieved sales revenue of RMB 3.006 billion, an increase of 10.3% compared to the previous year [1]. - The functional food and other businesses reported sales revenue of RMB 1.435 billion, up 11.2% year-on-year, mainly due to stable growth in sales of Guo Weikang [1]. Research and Development - R&D expenses increased by 7.9% to RMB 4.185 billion, accounting for 27.1% of the pharmaceutical business revenue [2]. - The company has nearly 90 products in various stages of clinical trials, with 14 submitted for market approval and over 30 key products in the registration clinical stage [2]. - The company is enhancing its internal innovation capabilities and increasing R&D investment, resulting in a rich pipeline of innovative assets [2]. - The company is actively promoting the internationalization of its R&D pipeline through licensing innovative products and strategic collaborations with multinational pharmaceutical companies [2].

每经AI快讯，有投资者在投资者互动平台提问：看到公司总经理实控人、副总董秘等这些高管都不是 医药研发背景专业人员，1、请问公司新药研发实力是否不咋地？研发专项顶尖高素质人员明显不足？ 2、公司是否注重医药销售？如果实力主要在于销售，那为什么不在美西方扩大销售医药品种？国内货 源很多。 3、公司生产基地主要在哪些城市布局？相比同行，有何优势？ （记者 王晓波） 健友股份（603707.SH）11月18日在投资者互动平台表示，1、公司目前拥有研发人员500余人，拥有一 批在全球有知名度的华裔FDA质量专家、无菌注射剂专家、生物研究和管理专家，均处于目前中国最优 秀的专家梯队。 2、公司是一家集药品研发、生产、销售为一体的制药企业，注重医药销售，我们近期 也在积极拓展海外销售市场，感谢您的建议。 3、公司的生产基地主要布局于南京和成都，目前公司拥 有12条通过美国FDA批准的生产线（南京布局9条生产线，成都布局3条生产线），所采用的生产设备可 靠、技术先进、自动化程度高、工艺技术稳定，在生产效率、生产稳定性、物耗能耗等方面都享有明显 优势，在保证生产质量的同时极大提高了生产效率。 ...

Group 1 - The company, Kew Flower Pharmaceutical (002737.SZ), announced a plan to invest up to 50 million yuan for the development of traditional Chinese medicine with the same name and formula, generic drug projects aligned with consistency evaluation, and research to expand indications for existing products [1] - The management has been authorized to oversee the progress and specific matters related to the project development [1] - This initiative aims to enrich the product pipeline and strengthen the company's long-term development momentum [1]

Group 1 - The company, Kew Flower Pharmaceutical (002737.SZ), announced a plan to invest up to 50 million yuan for the development of traditional Chinese medicine with the same name and formula, generic drug projects aligned with consistency evaluation, and research to expand indications for existing products [1] - The management has been authorized to oversee the progress and specific matters related to the project development [1] - This initiative aims to enrich the product pipeline and strengthen the company's long-term development momentum [1]

11月10日，据NMPA官网公示，齐鲁制药申报的恩他卡朋双多巴片(Ⅱ)获批上市并视同过评，用于治疗经左旋多巴/多巴脱羧酶（DDC）抑制剂疗法未能控 制的出现或伴有"剂末"运动功能波动的成人帕金森病患者。 据摩熵医药数据库（https://vip.pharnexcloud.com/?zmt-mhwz）显示，恩他卡朋双多巴片(Ⅱ)在市场上的表现十分亮眼。在2024年全终端医院市场，其销售 额接近2亿元，同比增长幅度高达18.39%；而到了2025年上半年，销售额更是突破1.2亿元，同比增长率达到了41.11%，发展势头迅猛。 | | | 截图来源：NMPA 恩他卡朋双多巴片(Ⅱ)原研由OrionPharma公司研发。恩他卡朋双多巴片于2003年首次获得FDA批准上市，用于治疗帕金森病。 截图来源：摩熵医药全终端医院数据库 2024年8月，石家庄四药申报的恩他卡朋双多巴片(Ⅱ)获批上市，为国内首仿。齐鲁制药于2022年启动了恩他卡朋双多巴片(Ⅱ)的研发。此次，齐鲁制药获 批上市的恩他卡朋双多巴片(Ⅱ)为国内第2家，形成原研1+国产2竞争格局。 | 恩他卡朋双多巴片 (II) | | | | | | | --- | ...

Summary of Key Points from the Conference Call Company Overview - The company discussed is 科笛 (Kedi), focusing on the commercialization of external Finasteride and Minocycline products, with significant revenue targets set for 2025 [2][5]. Industry and Product Insights - **External Finasteride**: - Revenue target for 2025 is over 50 million RMB, with expectations to achieve at least 200 million RMB within 12 months post-commercialization [2][5]. - Priced at 998 RMB, positioned in the high-end market, with potential for price adjustments [2][7]. - Monthly usage cost is comparable to competitors, but with better efficacy and fewer side effects [2][7]. - **Minocycline**: - Initial pricing set at 1,880 RMB, targeting the medical aesthetics channel, aiming to fill a gap in safe and effective topical antibiotics [2][10]. - Expected to exceed 20 million RMB in sales for 2025, with a target of at least 100 million RMB in the first year post-commercialization [4][5]. Commercialization Progress - Both products have shown strong initial sales performance, with external Finasteride completing import processes and shipping nationwide [3][4]. - Online pre-sales for Minocycline on platforms like JD.com have exceeded expectations, indicating robust market acceptance [3][4]. Financial Performance and Strategy - The company faced revenue impacts due to the cessation of collaboration with the OMA brand, but GSV showed actual growth when excluding this impact [4][13]. - The commercial team consists of approximately 120-130 members, with a focus on optimizing brand operations and sales efficiency [4][18]. Competitive Landscape - The external Finasteride market has competitors, such as Chengdu Beite, which may launch products in the near future [12][24]. - The company is aware of the competitive dynamics and is prepared to adjust its R&D and registration strategies accordingly [12][24]. Research and Development - The company is advancing a new drug project, 龙井村溶脂针, expected to enter Phase III clinical trials soon, which could enhance overall product synergy [2][15]. - Plans to potentially shift core ingredient production domestically to mitigate international supply chain risks [11]. Future Outlook - The company anticipates reaching a sales volume of 1 billion RMB for both key products by 2026, with stable gross margins projected between 70% and 80% [22][24]. - The strategy includes expanding online sales channels and integrating related cosmetic products to enhance brand value [20][21]. Conclusion - The company is positioned for growth with a strong product pipeline, effective commercialization strategies, and a focus on maintaining competitive advantages in the market [2][4][15].

Group 1 - Jiangsu Hengrui Medicine Co., Ltd. announced that its subsidiary Chengdu Shengdi Pharmaceutical Co., Ltd.'s HRS-5965 capsules have been proposed for inclusion in the priority review list by the National Medical Products Administration (NMPA) [1][2] - HRS-5965 capsules are intended for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have not previously received complement inhibitor therapy [1][2] - PNH is a rare acquired hemolytic disease characterized by the lack of CD55 and CD59, leading to complement-mediated intravascular hemolysis, and has been included in the national rare disease directory [2] Group 2 - The company has received approval from the NMPA for the clinical trial of Ruvelimab tablets, which are second-generation androgen receptor (AR) inhibitors, with a stronger AR inhibition effect compared to first-generation inhibitors [7][8] - Ruvelimab tablets were approved for the treatment of high-burden metastatic hormone-sensitive prostate cancer (mHSPC) in 2022, and similar products are projected to have a combined global sales of approximately $11.037 billion in 2024 [8] - The company has invested approximately 693.09 million yuan in the development of Ruvelimab tablets [8] Group 3 - The company has initiated a share repurchase program, with a total repurchase amount between 1 billion and 2 billion yuan, at a maximum price of 90.85 yuan per share [11][12] - As of October 31, 2025, the company has repurchased a total of 7.9188 million shares, accounting for 0.12% of the total share capital, with a total expenditure of approximately 535.43 million yuan [13] - The repurchase is in accordance with relevant laws and regulations and the company's established repurchase plan [14]

Investment Rating - The investment rating for the company is "Accumulate" (maintained) [2] Core Views - The company reported a significant increase in revenue and has multiple business development (BD) collaborations that are expected to drive future growth [8] - The company has a strong pipeline with clinical advancements in its CDH17 ADC and TCE platform, showcasing its R&D capabilities [8] - Revenue projections for 2025-2027 are estimated at 9.03 billion, 14.31 billion, and 22.72 billion RMB respectively, with a path to profitability expected by 2027 [8] Financial Performance - For the third quarter of 2025, the company achieved a revenue of 465 million RMB, representing a year-on-year growth of 1717.41% [8] - The total revenue for the first three quarters of 2025 reached 566 million RMB, a year-on-year increase of 301.03% [8] - The company's drug sales revenue for the third quarter was 55.32 million RMB, up 120.85% year-on-year, and for the first three quarters, it was 156 million RMB, up 72.10% year-on-year [8] Business Development Collaborations - The company has secured three BD collaborations, including a partnership with Qilu Pharmaceutical for the Agrestin α product, which includes a 380 million RMB upfront payment [8] - Collaborations with Calico and Kalexo involve significant upfront payments and milestone payments, indicating strong commercial potential [8] Clinical Development - The company’s self-developed CDH17 ADC has received approval for clinical trial applications from both the National Medical Products Administration and the FDA [8] - The TCE platform has established a comprehensive antibody library, enhancing its capabilities for targeted cancer therapies [8] Earnings Forecast - Projected revenues for 2025, 2026, and 2027 are 9.03 billion, 14.31 billion, and 22.72 billion RMB respectively, with corresponding net profits expected to be -648 million, -301 million, and 80 million RMB [7][8] - The company is expected to achieve an EPS of -1.62, -0.75, and 0.20 RMB for the years 2025, 2026, and 2027 respectively [7]

Core Viewpoint - Changchun High-tech's subsidiary, GenSci, has received approval for the clinical trial application of GenSci134 injection for domestic production, which is aimed at treating children with growth retardation due to endogenous growth hormone deficiency [1] Group 1: Company Developments - The clinical trial application for GenSci134 injection has been approved by the National Medical Products Administration [1] - The drug is classified as a Class 1 therapeutic biological product and is intended for children with growth issues [1] - GenSci134 has previously been approved for clinical trials in adults with growth hormone deficiency, indicating a potential expansion of its application [1] Group 2: Industry Implications - Successful progress in the clinical trials could help the company diversify its business structure and enhance its core competitiveness [1] - The development of pharmaceutical products is inherently uncertain, and there are risks associated with the clinical trial process [1]