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 Insights - The Hong Kong Innovative Drug ETF (159567) closed down 0.46% on October 20, with a trading volume of 907 million yuan [1] - The fund was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1] - As of October 17, 2024, the fund's shares totaled 8.134 billion, with a total size of 6.968 billion yuan, reflecting a significant increase in both shares and size compared to the previous year [1] Fund Performance - The fund has seen a remarkable increase of 1957.27% in shares and 1744.35% in size since December 31, 2023 [1] - The fund's cumulative trading amount over the last 20 trading days reached 27.487 billion yuan, with an average daily trading amount of 1.374 billion yuan [1] - Year-to-date, the cumulative trading amount is 224.063 billion yuan, averaging 1.173 billion yuan per day over 191 trading days [1] Fund Management - The current fund manager is Ma Jun, who has managed the fund since its inception, achieving a return of 71.34% during the management period [2] - The fund's top holdings include companies such as Innovent Biologics, WuXi Biologics, BeiGene, and others, with significant percentages of the portfolio allocated to these stocks [2]

Investment Rating - The investment rating for the pharmaceutical industry is "Positive" (maintained) [3] Core Viewpoints - The report emphasizes that the fourth quarter is expected to see a rebound in innovative drugs, driven by a concentration of business development (BD) activities and upcoming events such as the ESMO conference and medical insurance negotiations [4][16] - The Chinese pharmaceutical industry has completed a transition from old to new growth drivers, with innovative drugs significantly opening new growth avenues for Chinese pharmaceutical companies [16][35] - The report suggests that the demand for healthcare will continue to rise due to an aging population, and the payment side is also expected to grow steadily, supported by the development of a multi-tiered payment system [35] Summary by Sections 1. BD + ESMO - The number of license-out transactions in China has been increasing, with 135 transactions occurring from January 1, 2025, to October 17, 2025, totaling $10.2996 billion [8][9] - The report highlights that the international pharmaceutical industry recognizes the value of Chinese innovative drug assets, which are characterized by high quality and low cost [8][9] - The ESMO conference will showcase 23 studies led by Chinese scholars, indicating a significant increase in international recognition of Chinese innovation [12][13] 2. Industry Perspective - The report maintains that innovative drugs will remain the main focus for the year, with attention on manufacturing, overseas expansion, and aging-related consumption [16][35] - The pharmaceutical index has shown a decline of 2.48% in the past week, but an increase of 18.85% year-to-date, indicating a mixed performance [16] - The report lists several companies to watch, including innovative drug manufacturers and those involved in the supply chain [38]

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 Insights - The Hong Kong Innovative Drug ETF (159567) closed with a gain of 2.42% on October 16, with a trading volume of 1.486 billion yuan [1] - The fund was established on January 3, 2024, with an annual management fee of 0.50% and a custody fee of 0.10% [1] - As of October 15, 2024, the fund's shares reached 8.213 billion, with a total size of 7.102 billion yuan, reflecting a significant increase of 1977.25% in shares and 1779.88% in size compared to December 31, 2023 [1] Fund Performance - The current fund manager, Ma Jun, has achieved a return of 68.94% since taking over the fund on January 3, 2024 [2] - The ETF's top holdings include companies such as Innovent Biologics, WuXi Biologics, BeiGene, and others, with significant percentages of the portfolio allocated to these stocks [2] Trading Activity - Over the last 20 trading days, the ETF recorded a cumulative trading amount of 30.962 billion yuan, averaging 1.548 billion yuan per day [1] - Since the beginning of the year, the ETF has seen a total trading amount of 222.219 billion yuan over 189 trading days, averaging 1.176 billion yuan per day [1]

Major Events - Meili Tianyuan Medical Health (02373) acquires 100% of Shanghai Siyuanli Industrial for 1.25 billion yuan, aiming to capture the high-end beauty market in major cities [1] - Jinhai Medical Technology (02225) is actively preparing to participate in the 8th China International Import Expo [1] - China Biopharmaceutical (01177) has its selective MEK1/2 inhibitor TQ-B3234 included in the breakthrough therapy designation program [1] - Beijing Jiakesi plans to sell 90% of Jiakexi Health through capital increase and equity transfer agreements [1] - Green Power Environmental (01330) intends to invest in establishing a joint venture in Hong Kong to expand overseas environmental business [1] - Zhonghui Biotechnology (02627) applies for full circulation of H-shares [1] Operating Performance - Legend Holdings (03396) reports that its subsidiary, Legend New Science (003022.SZ), achieved a net profit attributable to shareholders of 232 million yuan in the first three quarters, an increase of 30.32% [1] - Mongol Mining (00975) reports total raw coal production of 3.6043 million tons from UHG and BN mines in the third quarter [1] - China Resources Power (00836) reports cumulative electricity sales of 161 million megawatt-hours from its subsidiary power plants in the first nine months, a year-on-year increase of 4.2% [1] - China Coal Energy (01898) reports coal sales of 19.66 million tons in September, a year-on-year decrease of 20.1% [1] - Air China (00753) reports a 1.2% year-on-year increase in passenger capacity input and a 5.6% year-on-year increase in passenger turnover in September [1]

Company News - China Coal Energy (01898.HK) reported a coal sales volume of approximately 190 million tons for the first nine months, a year-on-year decrease of 7.4%. In September, coal sales volume was 19.66 million tons, down 20.1% year-on-year [1] - China Southern Airlines (01055.HK) saw a 4.43% year-on-year increase in passenger capacity in September, with passenger turnover rising by 5.25%. The passenger load factor was 86.30%, an increase of 0.67 percentage points year-on-year. Cargo and mail turnover increased by 1.91% year-on-year [1] - China Eastern Airlines (00670.HK) reported a 3.63% year-on-year increase in passenger capacity for September, with passenger turnover up 8.67%. The passenger load factor was 87.57%, an increase of 4.06 percentage points year-on-year. Cargo and mail turnover rose by 10.95% year-on-year [1] - China Resources Power (00836.HK) achieved a cumulative electricity sales volume of 161 million MWh for the first nine months, an increase of 4.2% year-on-year, with wind power sales up 10.3% and solar power sales up 35.1% year-on-year [1] - Hopson Development Holdings (00754.HK) reported a total contract sales amount of 11.264 billion yuan for the first nine months, a year-on-year decrease of 12.62% [1] - China Design Group (01599.HK) won important project bids totaling approximately 3.175 billion yuan in the third quarter [1] - Jiumaojiu International Holdings (09922.HK) reported table turnover rates for its brands in the third quarter: 3.3 for Taier (self-operated only), 2.4 for Song Hotpot, and 2.5 for Jiumaojiu (self-operated only). Same-store average daily sales decreased by 9.3%, 19.1%, and 14.8% year-on-year, respectively, with the decline continuing to narrow [1][1] Financing and Buyback Activities - Xiaomi Group-W (01810.HK) repurchased 2 million shares for a total of approximately 98.9589 million HKD, with a repurchase price range of 49.42 to 49.54 HKD [5] - Yum China (09987.HK) repurchased 18,800 shares for approximately 6.2596 million HKD, with a repurchase price range of 330.6 to 340.2 HKD [6] - HSBC Holdings (00005.HK) repurchased 4.721 billion HKD worth of shares, totaling 4.6216 million shares, with a repurchase price range of 101.1 to 103.2 HKD [7] - Qiniu Intelligent (02567) has cornerstone investor He Shun voluntarily extend the lock-up commitment, representing approximately 3.20% of the total issued shares [8] - China Galaxy (06881.HK) completed the issuance of 4 billion HKD short-term financing bonds with a final coupon rate of 1.66%, primarily for working capital replenishment [8] - Huaneng International Power (00902.HK) issued 3 billion HKD ultra-short-term financing bonds with an issuance rate of 1.50% [9]