获受理10个多月后，天坛生物（SH600161，股价17.61元，市值348.22亿元）旗下一款投入2.66亿元研 发的血友病药物，撤回了上市申请。 11月19日晚间，这家国内头部血液制品公司发布公告，称下属企业成都蓉生药业有限责任公司（以下简 称成都蓉生）撤回了"注射用重组人凝血因子Ⅶa"的药品注册申请，原因是根据CDE（国家药品监督管 理局药品审评中心）的审评意见，需要补充儿童（＜12岁）患者群体的临床试验相关数据。 《每日经济新闻》记者注意到，目前国内共有2款同类药物获批，分别来自丹麦药企诺和诺德和国内药 企正大天晴药业集团南京顺欣制药有限公司（以下简称正大天晴），后者的药物于今年7月获批，适用 于符合条件的成人及青少年（12岁以上）先天性血友病患者的出血治疗。 那么，问题来了：同类国产药物的获批适应证不包含12岁以下患者，成都蓉生为何需要补充儿童数据？ 被外资企业占有九成以上份额的罕见病儿童药物市场，正在发生哪些变化？ 唯一国产药物7月获批 要了解注射用重组人凝血因子Ⅶa这款药物，首先要了解血友病。 在相关资料中，正大天晴表示该药物实现了本土化生产，打破了进口依赖，解决了进口rFⅦa供应短缺 的现状。 ...

Core Viewpoint - Tian Tan Bio's application for a hemophilia drug was withdrawn after 10 months of acceptance due to the need for additional clinical trial data for children under 12 years old, highlighting regulatory scrutiny in the rare disease market [2][11]. Company Summary - Tian Tan Bio's subsidiary Chengdu Rongsheng Pharmaceutical withdrew the registration application for "Recombinant Human Coagulation Factor VIIa Injection," which had a research investment of 266 million yuan [2][5]. - The drug's indication was aligned with that of imported products, focusing on adult and adolescent patients, but lacked data for younger patients, which is now a regulatory requirement [4][11]. - The company had previously completed a Phase III clinical trial, but the latest announcement did not specify age groups for the patient population [4][5]. Industry Summary - The hemophilia drug market in China is dominated by foreign companies, with over 90% market share, and there is a growing demand for domestic alternatives [12][13]. - The recent approval of a similar drug by Zhengda Tianqing, which does not cover children under 12, indicates a gap in the market that domestic companies are trying to fill [8][11]. - Regulatory bodies are pushing for comprehensive data that includes pediatric populations, reflecting a shift towards more inclusive treatment options for rare diseases [11][12]. - The domestic pharmaceutical industry is accelerating its efforts in rare disease drug development, with 21 rare disease drugs approved in the first half of 2025, indicating a positive trend towards addressing unmet medical needs [12][13].

Core Viewpoint - China Biologic Products (1177.HK) experienced a significant intraday drop of over 6%, trading at HKD 7.4, with a notable trading volume of nearly HKD 1.3 billion, indicating increased market activity [1] Financial Performance - The company reported a revenue of RMB 17.575 billion for its continuing operations in the first half of the year, representing a year-on-year increase of 10.71% [1] - The gross profit margin stood at 82.5%, reflecting a 0.4 percentage point increase [1] - Shareholder profit reached RMB 3.389 billion, marking a year-on-year growth of 12.31% [1] - Earnings per share were reported at RMB 0.1882, with an interim dividend of HKD 0.05 declared [1] Product Development - In the first half of the year, the company received NMPA approval for two innovative products, Putanling and Anqixin [1] - Revenue from innovative products amounted to RMB 7.8 billion, showing a year-on-year increase of 27.2% [1] - Additionally, five generic drugs received NMPA approval, contributing to positive growth in overall generic drug revenue during the same period [1]

Core Viewpoint - The domestic pharmaceutical industry is accelerating its recovery driven by policy support and innovation, with China National Pharmaceutical Group (01177.HK) reporting significant growth in its 2025 semi-annual performance [1][3]. Financial Performance - In the first half of the year, the company achieved revenue of 17.57 billion yuan and a net profit of 3.39 billion yuan, representing year-on-year growth of 10.7% and 140.2%, respectively [1][3]. - The company has maintained double-digit stable growth for three consecutive reporting periods [1][6]. Innovation and R&D - The company’s innovative transformation has shown significant results, with innovative product revenue reaching 7.8 billion yuan in the first half of the year, a strong year-on-year increase of 27.2%, accounting for 44.4% of total revenue [3][4]. - R&D expenses for the first half of the year amounted to 3.19 billion yuan, an increase of 610 million yuan from the previous year, with R&D expenses accounting for 18.1% of revenue [4][8]. - The company has received approval for 11 innovative products over the past two years, entering a period of intensive harvest [4][5]. Future Outlook - The company is confident in achieving double-digit growth for the full year, with innovative product revenue growth expected to exceed 25%, contributing over 3 billion yuan to overall performance [5][6]. - From 2025 to 2027, the company anticipates approval for 19 innovative products, with over half expected to exceed 2 billion yuan in sales peak [5][8]. Product Development - The company has made significant progress in key therapeutic areas, including oncology, liver disease, respiratory, and surgical/pain management, with multiple global first-in-class (FIC) and best-in-class (BIC) products [7][8]. - In the oncology sector, the company is advancing treatments for non-small cell lung cancer and breast cancer, with several products in various stages of clinical trials [7][8]. Market Position and Shareholder Returns - The company has a strong cash reserve of 30.5 billion yuan and plans to distribute dividends of 820 million yuan for the first half of 2025, an increase of over 60% from the previous year [8]. - The company's stock price has increased by over 150% this year, reflecting steady returns for shareholders [8].

Core Insights - The domestic pharmaceutical industry is accelerating its recovery driven by policy support and innovation [1] - China National Pharmaceutical Group (China Biopharma) reported a significant increase in revenue and net profit for the first half of 2025, achieving revenue of 17.57 billion yuan and a net profit of 3.39 billion yuan, representing year-on-year growth of 10.7% and 140.2% respectively [1][2] - The company is entering a dense harvest period for its R&D pipeline, with innovative product revenue reaching 7.8 billion yuan in the first half of the year, a strong year-on-year growth of 27.2% [2][3] Revenue and Profit Growth - The company has achieved double-digit stable growth for three consecutive reporting periods [1] - Innovative products now account for 44.4% of total revenue, with expectations to exceed 50% by the end of the year [1][2] - The company anticipates a full-year growth rate of over 25% for innovative product revenue, contributing more than 3 billion yuan to overall performance [2] R&D Investment and Product Pipeline - R&D expenses for the first half of the year reached 3.19 billion yuan, an increase of 610 million yuan year-on-year, representing 18.1% of total revenue [2] - The company has received approvals for 11 innovative products over the past two years, with several new products approved this year, including the first 24-hour long-acting NSAID injection [2][3] - The company plans to obtain approvals for 19 innovative products from 2025 to 2027, with over half expected to exceed 2 billion yuan in sales potential [3] Therapeutic Areas and Market Position - The company has made significant progress in four key therapeutic areas: oncology, liver disease, respiratory, and surgical/pain management [4][5] - In oncology, the company is advancing multiple products, including a dual-target antibody for non-small cell lung cancer and a CDK2/4/6 inhibitor for breast cancer [4] - The company has a strong pipeline in respiratory diseases, with a focus on multiple dosage forms and a leading position in clinical progress [4] Financial Health and Shareholder Returns - The company has a robust cash reserve of 30.5 billion yuan and plans to distribute dividends of 820 million yuan for the first half of 2025, a year-on-year increase of over 60% [5] - The company's stock price has increased by over 150% this year, reflecting steady long-term returns for shareholders [5]

Core Viewpoint - China Biologic Products (1177.HK) reported a mid-year profit attributable to shareholders of 3.389 billion yuan, representing a year-on-year increase of 12.31% [1] Financial Performance - Revenue from continuing operations reached 17.575 billion yuan, up 10.71% year-on-year [1] - Gross margin stood at 82.5%, an increase of 0.4 percentage points [1] - Earnings per share were 0.1882 yuan, with an interim dividend of 0.05 HKD declared [1] Product Development - The company received NMPA approval for two innovative products, Putan Ning and Anqi Xin, during the reporting period [1] - Revenue from innovative products amounted to 7.8 billion yuan, reflecting a year-on-year growth of 27.2% [1] - Additionally, five generic drugs were approved by NMPA, with overall revenue from generics maintaining positive growth in the first half of the year [1]

Core Viewpoint - The approval of "Recombinant Human Coagulation Factor VIIa Injection N01" by the National Medical Products Administration of China marks a significant milestone for the company as it is the first domestically approved product of its kind, providing a more economical and high-quality treatment option for patients [1] Group 1 - The product is the company's first recombinant human coagulation factor VIIa injection and the first of its kind in China [1] - The production process of recombinant human coagulation factor VIIa is complex, facing challenges such as degradation, oxidation sites, and various impurities [1] - The company has innovatively developed proprietary processes for cell culture, separation, purification, and formulation, resulting in two original patents [1] Group 2 - The product has successfully undergone multiple batches of commercial-scale production, demonstrating good consistency in quality between batches, which proves the robustness of the production process [1] - As the first domestically approved recombinant human coagulation factor VIIa product, it is expected to provide a more economical and high-quality treatment option for patients [1] - The company plans to offer a combination treatment solution through Anhengji and Anqixin, addressing the full spectrum of needs from routine replacement therapy to inhibitor management, potentially benefiting a broader population of hemophilia patients [1]