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]

Core Viewpoint - The domestic innovative drug industry is transitioning from a follower to FIC/BIC innovation, supported by engineer dividends, abundant clinical resources, and favorable policies, indicating a qualitative improvement as it enters the 2.0 era [1][2] Group 1: Industry Development - The innovative drug sector is expected to benefit from policy reforms in payment systems, enhancing the profitability of innovative drug companies as they commercialize domestic products [2] - The upcoming ESMO conference in mid-October is anticipated to provide new investment opportunities through the release of relevant clinical data and business development (BD) activities [2] Group 2: Investment Climate - The investment landscape has improved since early this year, with a notable reversal in the financing trend for the innovative drug industry, particularly in the A/H market [3] - The recovery of IPO projects and financing activities in the secondary market is expected to positively impact investment data in Q3, benefiting domestic CROs and upstream research sectors [3] Group 3: Policy Support - Continuous advancement of commercial medical insurance policies since 2025 is likely to accelerate payment system reforms, easing supply-demand conflicts and supporting domestic innovation [4] - Fiscal policy enhancements are expected to increase market interest in domestic medical equipment stocks [4] Group 4: Target Companies - A-share targets include: BeiGene (688235.SH), Hengrui Medicine (600276.SH), Kelun Pharmaceutical (002422.SZ), WuXi AppTec (603259.SH), Tigermed (300347.SZ), New Industry (300832.SZ), BGI Genomics (688114.SH), Huatai Medical (688617.SH), and Dian Diagnostics (300244.SZ) [5] - H-share targets include: Kelun Biotech (06990), CSPC Pharmaceutical (01093), China Biologic Products (01177), CanSino Biologics (09926), WuXi Biologics (02269), Junshi Biosciences (01877), and Zai Lab (09688) [5]

Group 1 - The Hang Seng Index rose by 0.04%, gaining 11 points to close at 26,840 points, while the Hang Seng Tech Index increased by 0.63% [1] - Shanghai Electric (601727) surged by 15.72%, hitting the upper limit in A-shares, driven by recent positive developments in the controllable nuclear fusion sector [1] - Hua Hong Semiconductor (01347) climbed 6.75%, reaching a new high as local supply chain integration accelerates, with domestic foundry demand expected to expand rapidly [1] - Jiangxi Copper (600362) shares rose by 11%, as the company is a leading copper smelter in China, with First Quantum's copper mine expected to resume production [1] - Luoyang Molybdenum (603993) increased by 8%, following a significant rise in cobalt prices, which surged over 11% in the previous two days due to strict export controls from the Congo [1] Group 2 - Hang Seng Bank (00011) saw a 26% increase, following HSBC's recommendation for its privatization [2] - Solar energy stocks experienced gains, with upstream prices rising more than downstream prices in September; New Special Energy (01799) rose 4.52%, Flat Glass (601865) increased by 7.67%, and GCL-Poly Energy (03800) gained 3.73% [2] - High-speed rail infrastructure stocks led the gains, with record railway investment progress; China Railway (601390) rose 9%, China Metallurgical Group (601618) increased by 6%, and CRRC Corporation (601766) gained 4.17% [2] - ZTE Corporation (00763) saw both A and H shares rise, with the launch of Co-Sight super intelligent system indicating positive growth potential in the enterprise AI market; H shares increased by 10.73% [2] Group 3 - Mixue Group (02097) rose 8.96% despite market trends, as it made a forward-looking investment in fresh beer brand Fulu, expanding its "tea + coffee + fresh beer" portfolio [3] - The Hang Seng Biotechnology Index fell by 3.52%, with notable declines in stocks such as Innovent Biologics (09969) down over 9%, I-Mab (01801) down over 6%, and China Biologic Products (01177) down over 6% [3] Group 4 - Smoore International (06969) dropped over 9%, having fallen more than 30% from its year-to-date high, with UBS projecting lower earnings than market consensus [4]

Group 1 - Hong Kong's Hang Seng Index rose by 0.04%, gaining 11 points to close at 26,840 points, while the Hang Seng Tech Index increased by 0.63% [1] - Shanghai Electric (02727) surged by 15.72%, with its A-shares hitting the daily limit, driven by positive developments in the controllable nuclear fusion sector [1] - Huahong Semiconductor (01347) climbed 6.75%, reaching a new high as domestic supply chain localization accelerates, with local foundry demand expected to expand rapidly [1] - Jiangxi Copper (00358) increased by 11%, being a leading copper smelting company in China, with a potential resumption of production at a copper mine owned by First Quantum [1] - Luoyang Molybdenum (03993) rose by 8%, as cobalt prices surged over 11% in the previous two days due to strict export controls in the Democratic Republic of Congo [1] - Hang Seng Bank (00011) jumped 26% following HSBC's recommendation to privatize the bank [1] - Solar stocks saw gains in early trading, with prices in the photovoltaic industry chain continuing to rise in September, particularly in upstream sectors [1] - High-speed rail infrastructure stocks led the gains, with record railway investment progress and the initiation of the "14th Five-Year" railway development planning [1] Group 2 - ZTE Corporation (00763) saw both A and H shares rise, with the overseas debut of its Co-Sight super intelligent system indicating positive growth potential in the enterprise AI market [2] Group 3 - Mixue Group (02097) rose 8.96% despite market trends, making a forward-looking investment in fresh beer brand Fulu, expanding its "tea + coffee + fresh beer" portfolio [3] - The Hang Seng Biotechnology Index fell by 3.52%, with several constituent stocks like Innovent Biologics (09969) and Sino Biopharmaceutical (01177) experiencing declines of over 6% [3] - Smoore International (06969) dropped over 9%, having fallen more than 30% from its yearly high, with UBS projecting lower earnings than market consensus [3]

Core Viewpoint - The Hong Kong stock market experienced a decline, with the Hang Seng Index falling by 0.6% and the Hang Seng Tech Index decreasing by 0.22% [1] Group 1: Market Performance - The pharmaceutical sector faced significant losses, with notable declines in specific companies [1] - Nocera Healthcare and SiHuan Pharmaceutical both dropped over 8% [1] - China Biologic Products and Hansoh Pharmaceutical saw declines exceeding 4% [1]