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]

机构：招银国际 研究员：武煜/黄本晨 维持买入评级。维持基于DCF 的目标价9.40 港元（WACC: 10.01%, 永续增长率：2.0%）。我们预计中 国生物制药2025E/ 26E/ 27E 收入增速为+19.1%/+4.4%/ +10.6% ，经调整净利润增速为+81.3%/ -30.0%/ +11.3%。出于谨慎考虑，我们暂未考虑潜在对外授权对收入和利润的贡献。 临床数据表明TQC3721 具备同类最佳潜力。 TQC3721 6mg 组在4 周治疗后的FEV1峰值比安慰剂组高 147ml，与恩司芬群12周临床数据（146/ 147ml。 非头对头数据比较，下同）一致，FEV1 AUC（0-12h）比安慰剂高87ml，也与恩司芬群12 周数据 （87/94ml）处在同一水平。值得注意的是，TQC3721 临床试验的全部受试者均已接受COPD 药物治 疗，其中30%的受试者使用了LAMA（长效抗胆碱能药物），70%同时使用LABA（长效β2 受体激动 剂）和LAMA 药物，而恩司芬群的临床实验中约38%的受试者为初治患者。因此，TQC3721 的临床入 组的患者基线更差。考虑到实际生活中COPD患者普遍 ...

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 ...

Core Points - Boehringer Ingelheim has officially launched the local production of its diabetes drug, Onglyza (linagliptin), in China, marking the company's first local production of a human medication in the country [1] - The local production plan is expected to significantly enhance the supply stability of Onglyza in the Chinese market [1] - The CEO of China National Pharmaceutical Group, Xie Chengrun, attended the launch ceremony, indicating a partnership between Boehringer Ingelheim and the Chinese biopharmaceutical company [1]

Investment Rating - The report maintains a "Buy" rating for the company, with a target price of HKD 9.40, indicating a potential upside of 20.5% from the current price of HKD 7.80 [4][10]. Core Insights - The clinical data for the PDE3/4 inhibitor TQC3721 shows promising results, with significant improvements in lung function and symptoms for patients with severe COPD after 4 weeks of treatment [1][2]. - TQC3721 is positioned as the second globally in development and the only PDE3/4 inhibitor currently in Phase III clinical trials, suggesting substantial market potential and opportunities for licensing [10][12]. - The financial projections indicate a revenue growth of 19.1% for FY25E, with adjusted net profit expected to increase by 81.3% in the same year [3][13]. Financial Summary - Sales revenue (in million RMB) is projected to grow from 26,199 in FY23A to 34,380 in FY25E, reflecting a year-on-year growth of 19.1% [3][17]. - Adjusted net profit is expected to rise from 2,589 in FY24A to 6,267 in FY25E, marking an increase of 81.3% [3][13]. - The adjusted earnings per share (EPS) is forecasted to reach RMB 0.33 in FY25E, with a corresponding adjusted P/E ratio of 21.6 [3][10]. Clinical Data Highlights - In the Phase II clinical trial, TQC3721 demonstrated a peak FEV1 improvement of 147ml compared to the placebo group, aligning with the results of the approved competitor, ensifentrine [2][10]. - The safety profile of TQC3721 is favorable, with no significant adverse effects reported in gastrointestinal, cardiovascular, or renal functions during the trials [1][10]. Market Context - The global COPD market is substantial, with nearly 480 million affected individuals, and TQC3721's development is timely given the increasing demand for effective treatments [10][12]. - The competitive landscape is highlighted by the recent FDA approval of ensifentrine, which underscores the potential for TQC3721 to capture market share as it progresses through clinical trials [10][12].

Core Viewpoint - 招银国际 maintains a target price of HKD 9.4 for China Biologic Products (01177) and a "Buy" rating based on a DCF model, projecting revenue growth rates of 19.1% in 2025, 4.4% in 2026, and 10.6% in 2027 [1] Revenue and Profit Projections - The firm expects adjusted net profit growth rates of 81.3% in 2025 and 11.3% in 2027, with a significant decline of 30% anticipated in 2026 [1] - Potential contributions from external licensing to revenue and profit have not been considered in these projections [1] Clinical Development Insights - Recent Phase II clinical results for the PDE3/4 inhibitor TQC3721 indicate that it can rapidly improve lung function and symptoms in patients [1] - The firm believes TQC3721 has the potential to become a blockbuster drug and has significant external licensing potential [1]

Core Viewpoint - 招银国际 maintains a target price of HKD 9.4 for China Biologic Products (01177) and a "Buy" rating based on a DCF model, projecting revenue growth rates of 19.1% in 2025, 4.4% in 2026, and 10.6% in 2027 [1] Revenue and Profit Projections - The firm expects adjusted net profit growth rates of 81.3% in 2025 and 11.3% in 2027, with a significant decline of 30% anticipated in 2026 [1] - Potential contributions from external licensing to revenue and profit have not been considered in these projections [1] Clinical Development Insights - China Biologic Products recently announced Phase II clinical results for its PDE3/4 inhibitor TQC3721, which demonstrated rapid improvement in patients' lung function and symptoms [1] - The firm believes TQC3721 has the potential to become a blockbuster drug and has significant external licensing potential [1]