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]

Core Viewpoint - China National Pharmaceutical Group's TQ-B3234, a selective MEK1/2 inhibitor, has been included in the Breakthrough Therapy Designation (BTD) program by the Center for Drug Evaluation (CDE) for the treatment of symptomatic, unresectable neurofibromatosis type I (NF1) related plexiform neurofibromas in adults [1] Group 1 - TQ-B3234 is a selective MEK1/2 inhibitor that targets the RAS-regulated RAF/MEK/ERK pathway to inhibit tumor growth [1] - The Phase III registration clinical study for TQ-B3234 in treating adult plexiform neurofibromas has been approved by CDE, aiming to confirm its efficacy and safety in a larger patient population [1] - Inclusion in the BTD program will accelerate the drug's market launch process, potentially benefiting more patients sooner [1]

（於開曼群島註冊成立之有限公司） 網站：www.sinobiopharm.com （股份編號：1177） 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。 1 NF1是由NF1基因突變引起的常染色體顯性遺傳疾病，約佔所有神經纖維瘤病的96%，在中國新生兒 中預估發病率為百萬分之五[2]，2023年9月被納入中國《第二批罕見病目錄》。其中，約30%-60%的 NF1患者會發展為PN，導致疼痛、毀容甚至惡變。目前，手術是主要治療手段，但面臨高難度和易 復發等挑戰。 根據2025年《叢狀神經纖維瘤全病程管理專家共識》，對於無法手術的患者，首選MEK抑制劑進行靶 向治療以控制疾病。MEK抑制劑已證實在兒童患者中有效並有藥物在中國獲批上市，但國內的成人 PN患者目前仍缺乏有效治療藥物，治療需求遠未得到滿足。 TQ-B3234用於治療成人PN的Ⅲ期註冊臨床研究已獲CDE批准。該研究旨在更大規模的患者群體中確 證其療效與安全性，以填補國內治療空白。此次TQ-B323 ...

Core Insights - The 2025 European Society for Medical Oncology (ESMO) annual meeting will take place in Germany from October 17 to 21, where several significant oral reports from domestic innovative pharmaceutical companies are expected to be disclosed [1] - China National Pharmaceutical Group is set to present key data on its CDK2/4/6 inhibitor, Kumosili, and HER2 dual-target ADC, TQB2102, highlighting its comprehensive coverage in the breast cancer treatment landscape [1] Industry Overview - Breast cancer is the second most common cancer globally, following lung cancer, and has the highest incidence and mortality rates among women [1] - The breast cancer market is highly competitive, particularly in the HR+/HER2- subtype, which accounts for approximately 65%-70% of all breast cancer cases [2] - The global market for CDK4/6 inhibitors is projected to approach $13 billion by 2024, with ongoing growth driven by products from Pfizer, Eli Lilly, and Novartis [2] Company Developments - Kumosili capsules, a new generation CDK2/4/6 inhibitor, are expected to receive approval for second-line treatment of HR+/HER2- locally advanced or metastatic breast cancer by the end of this year [3] - The company is also advancing its clinical trials for Kumosili in first-line and adjuvant settings, aiming for comprehensive coverage across treatment lines [3] - TQB2102, another product from China National Pharmaceutical Group, will present phase Ib clinical data for HER2-positive recurrent/metastatic breast cancer at ESMO [3] Competitive Landscape - The ADC market for HER2-positive breast cancer is evolving, with significant sales from existing products like DS-8201, which reached $3.8 billion last year and is projected to peak at $10 billion [4] - TQB2102 has been optimized in terms of target binding, toxin load, and payload compared to DS-8201, and has been recognized as a breakthrough therapy for multiple indications [4] - The company has a diverse pipeline covering various cancer types, including breast, colorectal, lung, bile duct, and gastric cancers, with several indications entering phase III clinical trials [4]

Core Insights - China Biopharmaceutical presented positive Phase II clinical results for its PDE3/4 inhibitor TQC3721 at the European Respiratory Society 2025 conference, showing rapid improvement in lung function and symptoms for COPD patients [1][2] Group 1: Clinical Results - TQC3721 demonstrated significant improvements in FEV1 peak values compared to the placebo group, with increases of 100ml and 147ml for the 3mg and 6mg groups respectively after 4 weeks of treatment [1] - In the subgroup of patients using LAMA and LABA/LAMA, the 6mg group showed a FEV1 peak increase of 239ml compared to the placebo group [1] - The safety profile of TQC3721 was favorable, with no significant adverse effects observed in gastrointestinal, cardiovascular, or liver and kidney functions during the clinical trial [1] Group 2: Comparative Analysis - TQC3721's clinical data suggests it has best-in-class potential, with the 6mg group showing FEV1 peak values consistent with those of the recently approved drug ensifentrine [2] - The baseline characteristics of TQC3721 trial participants were poorer compared to those in the ensifentrine trials, indicating a greater potential for clinical benefit in real-world COPD patients [2] Group 3: Market Potential - The global COPD market is substantial, with nearly 480 million affected individuals worldwide, and over 100 million in China, making it a significant health and economic burden [3] - The recent acquisition of Verona by Merck for $10 billion highlights the market potential for PDE3/4 inhibitors, with ensifentrine's sales showing strong growth [3] - TQC3721, being the second globally in development and the only PDE3/4 inhibitor in Phase III trials, is positioned for significant overseas licensing opportunities [3]

Core Insights - China National Pharmaceutical Group's self-developed drug TQB2102 has been included in the Breakthrough Therapy Designation (BTD) program by the National Medical Products Administration (NMPA) for the treatment of HER2 IHC 3+ advanced colorectal cancer that has failed previous treatments with oxaliplatin, irinotecan, and fluorouracil [1][2] - TQB2102 is a dual-targeting antibody-drug conjugate (ADC) that targets HER2 protein ECD2 and ECD4 non-overlapping epitopes, showing significant efficacy in colorectal cancer treatment [1] - Preliminary data from the Phase I clinical trial presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting indicates an objective response rate (ORR) of 34.8% in patients with HER2 high expression (HER2 IHC 3+) [1] Industry Context - There is currently a lack of specific targeted treatment options for advanced colorectal cancer with HER2 overexpression, with existing second-line treatments showing low efficacy [2] - The objective response rate (ORR) for third-line treatment options is only 1.0%-2.0%, with progression-free survival (PFS) ranging from 1.9 to 3.7 months and overall survival (OS) between 6.4 to 7.4 months, highlighting the urgent need for effective treatment solutions [2] - The inclusion of TQB2102 in the BTD program is expected to accelerate its market entry, potentially transforming the treatment landscape for HER2 IHC 3+ colorectal cancer [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） 資料來源： TQB2102「HER2雙抗ADC」納入突破性治療藥物程序 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，本集團自 主研發的國家1類新藥注射用TQB2102「HER2雙特異性抗體偶聯藥物(ADC)」已被中國國家藥品監督 管理局藥品審評中心(CDE)納入突破性治療藥物程序(BTD)，用於既往經奧沙利鉑、伊立替康、氟尿 嘧啶類藥物治療失敗的HER2 IHC 3+晚期結直腸癌的治療。 自願公告 TQB2102是一款同時靶向HER2蛋白ECD2及ECD4雙非重疊表位的雙抗ADC藥物，憑藉差異化的 設計在結腸癌治療中顯示出強效優勢。本集團已在2025年美國臨床腫瘤學會(ASCO)年會上公佈了 TQB2102的I期臨床研究初步數據[1]。截至2024年10 ...