股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年10月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 中國生物製藥有限公司 呈交日期: 2025年11月3日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01177 | 說明 | - | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 30,000,000,000 | HKD | | 0.025 HKD | | 750,000,000 | | 增加 / 減少 (-) | | | 0 | | | HKD | | 0 | | 本月底結存 | | 30,000,000,000 | | HKD | | 0.025 HKD | | 750,000,000 | 本月底法定/註冊股本總額： ...

Core Insights - The 12th China Healthcare Summit, co-hosted by BioCentury and BayHelix, highlighted the significant acquisition of Lixian Pharmaceutical by China National Pharmaceutical for approximately $1 billion, earning the "Company of the Year" award for 2025 [1][2] - The summit showcased the record-breaking foreign licensing deals in China's innovative drug sector, surpassing $100 billion for the first time in a single year, reflecting the growing maturity of China's biopharmaceutical technology [1] Group 1: Acquisition Highlights - The acquisition of Lixian Pharmaceutical by China National Pharmaceutical is noted as a rare instance of a domestic company acquiring a local innovator within China's evolving biotech ecosystem [2] - This deal grants China National Pharmaceutical access to eight clinical projects, including a dual-target PD-1x VEGF antibody, which has already attracted significant global interest [2][3] - The acquisition is viewed as a milestone in the history of China's biopharmaceutical development, marking a key sign of the industry's maturation and upgrade [2] Group 2: R&D Progress - Following the acquisition, Lixian Pharmaceutical has accelerated its R&D progress, with two indications for the new drug LM-302 (CLDN18.2ADC) included in the breakthrough therapy category by the National Medical Products Administration [3] - The dual-target antibody LM-24C5 has received approval to commence Phase II clinical trials for advanced solid tumors, while the ADC drug LM-350 has successfully completed patient enrollment in a Phase I trial in Australia [3]

Core Insights - China National Pharmaceutical Group received the "Company of the Year" award at the 2025 BayHelix Awards due to its significant acquisition of Lixian Pharmaceutical for approximately $1 billion [1] - The acquisition is notable as it marks a domestic pharmaceutical company acquiring a local innovator within China's evolving biotech ecosystem [1] - This transaction enabled China National Pharmaceutical Group to gain access to eight clinical projects [1]

Core Insights - Morgan Stanley's research report indicates that Innovent Biologics has announced a global collaboration agreement with Takeda Pharmaceutical, involving an upfront payment of $1.2 billion and potential milestone payments of up to $11.4 billion, making it the second-largest out-licensing deal globally based on transaction value [1] Group 1 - The agreement involves the joint development of IBI363, with commercialization in the U.S. market, where research and profit/loss will be shared in a 60/40 ratio [1] - Innovent grants Takeda commercialization rights outside Greater China and the U.S., with Takeda responsible for potential development and sales milestone payments, as well as royalties [1] Group 2 - The arrangement is expected to strengthen Innovent's market position in the U.S. and develop the capabilities needed for independent global clinical development and commercialization [1] - Morgan Stanley reaffirms Innovent Biologics as a preferred choice in China's biopharmaceutical sector, setting a target price of HKD 110 and maintaining an "Overweight" rating [1]

Core Insights - China Biopharmaceutical announced the interim analysis results of the Phase III clinical trial (CULMINATE-2) for its innovative drug, Kumosili capsules, presented at the 2025 European Society for Medical Oncology (ESMO) [1] - CULMINATE-2 is the first global Phase III trial demonstrating positive results for an oral CDK2/4/6 inhibitor combined with endocrine therapy for HR+/HER2- advanced breast cancer [1] Group 1 - Kumosili is a novel oral CDK2/4/6 inhibitor with varying degrees of inhibition on CDK2, CDK4, and CDK6, showing strong selectivity against CDK4, which may help delay clinical resistance and reduce bone marrow suppression [2] - The China National Medical Products Administration (NMPA) accepted the marketing application for Kumosili combined with Fulvestrant for previously treated HR+/HER2- locally advanced or metastatic breast cancer in July 2024, with a second indication application expected in July 2025 [2] - The company is actively advancing a Phase III clinical trial for Kumosili in adjuvant therapy for breast cancer, having completed patient enrollment, with plans to submit a marketing application in the next two years [2] Group 2 - Kumosili is expected to comprehensively cover the treatment cycle for HR+/HER2- breast cancer, including first-line, subsequent lines, and adjuvant therapy, providing innovative treatment options for more patients [2]

Core Insights - China Biologic Products (01177) announced the mid-analysis results of the Phase III clinical trial (CULMINATE-2) for its innovative drug, Kumosili capsules (CDK2/4/6 inhibitor), for first-line treatment of HR+/HER2- advanced breast cancer at the 2025 European Society for Medical Oncology (ESMO) [1] - CULMINATE-2 is the first global Phase III trial demonstrating positive results for an oral CDK2/4/6 inhibitor combined with endocrine therapy in HR+/HER2- advanced breast cancer [1] - Kumosili shows selective inhibition of CDK4 kinase, which may help delay clinical resistance and reduce bone marrow suppression, potentially positioning it as a Best-in-Class therapy [1] Regulatory Developments - The Center for Drug Evaluation (CDE) of the National Medical Products Administration has accepted the marketing application for Kumosili combined with Fulvestrant for previously treated HR+/HER2- locally advanced or metastatic breast cancer, expected to be reviewed by July 2024 [2] - A second indication for initial endocrine treatment in HR+/HER2- locally advanced or metastatic breast cancer is also under review, with an expected decision by July 2025 [2] - The company is advancing a Phase III clinical trial for Kumosili in adjuvant therapy, with all participants enrolled and a marketing application anticipated within the next two years [2] Market Potential - Kumosili is expected to comprehensively cover the treatment cycle for HR+/HER2- breast cancer, including first-line, subsequent lines, and adjuvant therapy, providing innovative treatment options for more patients [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完 整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部份內容而產生或因倚賴該等內 容而引致的任何損失承擔任何責任。 （於開曼群島註冊成立之有限公司） 網站：www.sinobiopharm.com （股份編號：1177） 自願公告 庫莫西利聯合氟維司群一線治療晚期乳腺癌III期研究數據在ESMO 2025公佈 中國生物製藥有限公司（「本公司」，連同其附屬公司統稱「本集團」）董事會（「董事會」）宣佈，本集團已 在2025年歐洲腫瘤內科學大會(ESMO)上以最新重磅摘要(LBA)的形式，公佈了國家1類創新藥庫莫西 利膠囊（CDK2/4/6抑制劑）用於一線治療HR+/HER2-晚期乳腺癌的III期臨床研究(CULMINATE-2)期 中分析結果。 CULMINATE-2是全球首個口服CDK2/4/6抑制劑聯合內分泌治療用於HR+/HER2-晚期一線乳腺癌取 得陽性結果的III期臨床試驗。這項隨機、雙盲、多中心平行對照研究，旨在評估庫莫西利聯合氟維 司群（試驗組）對比安慰劑聯合氟維司群（對照組）在內分泌初治的HR+/HER2 ...

Core Viewpoint - China Biopharmaceutical (01177) maintains a buy rating with a target price of HKD 9.4, based on DCF analysis with a WACC of 10.01% and a perpetual growth rate of 2.0% [1] Financial Projections - Expected revenue growth rates for China Biopharmaceutical are +19.1% in 2025, +4.4% in 2026, and +10.6% in 2027 [1] - Adjusted net profit growth rates are projected at +81.3% in 2025, -30.0% in 2026, and +11.3% in 2027 [1] Clinical Results of TQC3721 - TQC3721, a PDE3/4 inhibitor, showed significant improvement in lung function and symptoms in a Phase II clinical trial involving 240 moderate to severe COPD patients [2] - After 4 weeks of treatment, the FEV1 peak values for the 3mg and 6mg groups were higher than the placebo group by 100ml and 147ml, respectively [2] - The 6mg group also demonstrated a significant FEV1 AUC (0-12h) increase of 87ml compared to the placebo group, with a SCRQ score improvement of 5.09 units [2] Comparative Analysis - TQC3721's clinical data indicates it has the potential to be a best-in-class treatment, with FEV1 peak values comparable to those of the recently approved drug Ensofen [3] - The patient baseline in TQC3721's trial was worse, as 30% had previously used LAMA and 70% used LABA/LAMA, suggesting greater clinical benefit potential for real-world COPD patients [3] Market Potential - The global COPD market is substantial, with nearly 480 million affected individuals, and over 100 million in China, making it a significant health concern [4] - The recent FDA approval of Ensofen, the first new mechanism COPD drug in over 20 years, highlights the market's potential, with sales reaching USD 0.71 million and USD 1.03 million in Q1 and Q2 2025, respectively [4] - The acquisition of Verona by Merck for USD 10 billion underscores the significant market opportunity for PDE3/4 inhibitors, positioning TQC3721 as a strong candidate for overseas licensing [4]

Core Viewpoint - China Biopharmaceutical (01177) maintains a buy rating with a target price of HKD 9.4, based on a DCF model with a WACC of 10.01% and a perpetual growth rate of 2.0% [1] Financial Projections - Expected revenue growth rates for China Biopharmaceutical are +19.1% in 2025, +4.4% in 2026, and +10.6% in 2027 [1] - Adjusted net profit growth rates are projected at +81.3% in 2025, -30.0% in 2026, and +11.3% in 2027 [1] - The firm has not factored in potential contributions from external licensing agreements to revenue and profit due to cautious considerations [1] Clinical Results of TQC3721 - TQC3721, a PDE3/4 inhibitor, showed promising results in a Phase II clinical trial, significantly improving lung function and symptoms in patients with moderate to severe COPD [2] - In the trial, patients receiving 3mg and 6mg doses of TQC3721 had FEV1 peak values higher than the placebo group by 100ml and 147ml, respectively [2] - The 6mg group also demonstrated a significant improvement in FEV1AUC (0-12h) by 87ml compared to the placebo [2] - The safety profile of TQC3721 was favorable, with no significant adverse effects observed in gastrointestinal, cardiovascular, or liver and kidney functions [2] Comparative Analysis - TQC3721's clinical data suggests it has best-in-class potential, with FEV1 peak values comparable to those of the approved drug ensifentrine [3] - The patient population in TQC3721's trial had a worse baseline compared to those in ensifentrine's trial, indicating a greater potential for clinical benefit in real-world COPD patients [3] - In the subgroup of patients using LAMA, the 6mg group of TQC3721 had a FEV1 peak value higher than the ensifentrine group by 104ml [3] Market Potential - The COPD market is substantial, with nearly 480 million affected globally and over 100 million in China, making it a significant health and economic burden [4] - The recent FDA approval of ensifentrine, the first new mechanism COPD drug in over 20 years, highlights the market's potential, with sales reaching USD 0.71 million and USD 1.03 million in Q1 and Q2 2025, respectively [4] - The acquisition of Verona by Merck for USD 10 billion underscores the significant market opportunity for PDE3/4 inhibitors [4] - TQC3721, being the second globally in development and the only one in Phase III, is seen as having substantial potential for overseas licensing [4]

Core Viewpoint - China Biopharmaceutical (01177) has announced that its self-developed national class 1 new drug TQ-B3234 capsule, a selective MEK1/2 inhibitor, has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the treatment of symptomatic, unresectable neurofibromatosis type I (NF1) related adult plexiform neurofibromas [1] Group 1 - TQ-B3234 is a selective MEK1/2 inhibitor that targets the upstream regulatory factor of the extracellular signal-regulated kinase (ERK) pathway, which can inhibit tumor growth by suppressing the activity of the RAS-regulated RAF/MEK/ERK pathway [1] - The phase III registration clinical study for TQ-B3234 in treating adult plexiform neurofibromas has been approved by the CDE, aiming to confirm its efficacy and safety in a larger patient population to fill the domestic treatment gap [1] - The inclusion of TQ-B3234 in the BTD program will accelerate the drug's market launch process, potentially benefiting more patients sooner [1]