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，本集團全 資附屬公司禮新醫藥科技（上海）有限公司（「禮新醫藥」）自主研發的國家1類創新藥維特柯妥拜單抗（研 發代號：LM-302）「CLDN18.2 ADC」正在開展用於治療三線及以上CLDN18.2陽性的局部晚期或轉移 性胃及胃食管交界部腺癌的III期註冊臨床試驗(LM302-03-101)，已順利完成患者入組。其中，LM- 302是全球首款完成註冊III期臨床試驗入組的CLDN18.2 ADC藥物。 LM-302是一款靶向CLDN18.2的抗體偶聯藥物(ADC)，通過與CLDN18.2陽性腫瘤細胞特異性結合， 並經內吞作用進入細胞後釋放小分子毒素，從而實現對腫瘤細胞的精準殺傷。作為潛在同類首創 (FIC)藥物，LM-302在胃癌、胰腺癌及膽道癌等多個消化道腫瘤中展現出良好的臨床開發潛力，並有 望為CLDN18.2低表達和PD-L1低表達患者提供新的治療選擇。 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 ...

截至月份: 2026年1月31日 狀態: 新提交 致：香港交易及結算所有限公司 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 公司名稱: 中國生物製藥有限公司 呈交日期: 2026年2月2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 | | | | 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： HKD ...

Core Viewpoint - The report from CMB International indicates an adjustment in the profit forecast for China Biologic Products (01177) for 2025 to 2027, reflecting a decrease of 6%, an increase of 9%, and a decrease of 2% respectively, along with a revised DCF target price of HKD 8.5, corresponding to a 42 times P/E ratio for 2026 and a PEG of 1.3 based on core net profit predictions, while maintaining a "Buy" rating [1] Group 1 - CMB International forecasts that the growth rate of the Chinese biopharmaceutical industry is expected to maintain double digits from 2026 to 2027, driven by contributions from existing major products and several newly launched products, manageable centralized procurement risk exposure, and the normalization potential of BD revenue [1] - The company is transitioning its growth path from pipeline expansion to the layout of next-generation technology platforms, and from solely introducing products to a dual approach of introducing and going global, indicating the emergence of a global MNC big pharmaceutical enterprise [1]

Core Viewpoint - The report from CMB International indicates a revision in the profit forecast for China Biologic Products (01177) for 2025 to 2027, reflecting a decrease of 6%, an increase of 9%, and a decrease of 2% respectively, alongside a lowered DCF target price to HKD 8.5, corresponding to a 42 times P/E ratio for 2026 and a PEG of 1.3 based on core net profit predictions, while maintaining a "Buy" rating [1] Group 1 - CMB International anticipates that the growth rate of the Chinese biopharmaceutical industry is likely to maintain double digits from 2026 to 2027, driven by contributions from existing major products and several newly launched products, manageable procurement risk exposure, and the normalization potential of BD revenue [1] - The company is transitioning from pipeline expansion to the layout of next-generation technology platforms, and from merely introducing products to a dual approach of introducing and going global, indicating the emergence of a global MNC big pharmaceutical enterprise [1]

Core Viewpoint - The Chinese biopharmaceutical industry is expected to maintain double-digit growth from 2026 to 2027, driven by existing major products, several new product launches, manageable procurement risk exposure, and the normalization potential of BD revenue [1] Group 1: Company Insights - China National Pharmaceutical Group is transitioning from pipeline expansion to the layout of next-generation technology platforms, and from merely introducing products to a strategy that includes both introduction and international expansion, indicating the emergence of a global multinational pharmaceutical enterprise [1] - The forecast for the company's net profit from 2025 to 2027 has been adjusted to a decrease of 6%, an increase of 9%, and a decrease of 2%, respectively, reflecting updated predictions on product sales and revenue recognition from licensing collaborations [1] Group 2: Financial Adjustments - The DCF target price has been lowered to 8.5 HKD, while maintaining a "Buy" rating, indicating a positive long-term outlook despite short-term profit adjustments [1]

Core Insights - China Biopharmaceutical (01177) announced that its self-developed national class 1 innovative drug TQA3605, a core protein allosteric modulator (CpAM), has recently completed a phase II clinical trial for patients with chronic hepatitis B virus (HBV) infection, achieving its primary endpoint [1] Group 1: Clinical Trial Results - The study was a randomized, double-blind, placebo-controlled, multi-center phase II trial (NCT06644417) aimed at evaluating the efficacy and safety of TQA3605 in combination with nucleos(t)ide analogs (NAs) in treated patients with low viral load [1] - A total of 122 subjects were enrolled, divided into a placebo control group and multiple different dosage groups of TQA3605, administered orally once daily [1] - Results showed that among adult HBV-infected patients who had received NAs treatment for at least 12 months, TQA3605 combined with NAs for 24 weeks significantly increased the proportion of subjects with HBV DNA below the lower limit of quantification (<20 IU/mL), with nearly 90% in all dosage groups, significantly better than the NAs monotherapy control group (p < 0.0001) [1] - In terms of safety, TQA3605 demonstrated overall good safety, with the incidence of adverse reactions comparable to the control group, and most treatment-emergent adverse events (TEAEs) were of grade 1-2, with no new safety signals observed [1] Group 2: Drug Profile and Market Potential - TQA3605 is a core protein modulator developed by the company that can effectively inhibit multiple genotypes of HBV and has no cross-resistance with NAs [2] - Currently, there are no approved core protein modulators for HBV globally, and compared to other similar investigational drugs, TQA3605 shows superior safety and a more convenient once-daily oral administration, potentially providing a new treatment option for chronic HBV-infected patients [2]

Core Insights - China Biopharmaceutical (01177) announced that its self-developed national class 1 innovative drug TQA3605, a core protein allosteric modulator (CpAM), has recently completed a phase II clinical trial for patients with chronic hepatitis B virus (HBV) infection, achieving its primary endpoint [1] Group 1: Clinical Trial Results - The study was a randomized, double-blind, placebo-controlled, multi-center phase II trial (NCT06644417) aimed at evaluating the efficacy and safety of TQA3605 in combination with nucleos(t)ide analogs (NAs) in chronic HBV-infected subjects with low viral load [1] - A total of 122 subjects were enrolled, divided into a placebo control group and multiple different dosage groups of TQA3605, administered orally once daily [1] - Results showed that among adult HBV-infected patients who had received NAs treatment for at least 12 months, TQA3605 combined with NAs for 24 weeks significantly increased the proportion of subjects with HBV DNA below the lower limit of quantification (<20 IU/mL) to nearly 90% across all dosage groups, significantly outperforming the NAs monotherapy control group (p<0.0001) [1] - In terms of safety, TQA3605 demonstrated overall good safety, with the incidence of adverse reactions comparable to the control group, and most treatment-emergent adverse events (TEAEs) were of grade 1-2, with no new safety signals observed [1] Group 2: Drug Profile and Market Potential - TQA3605 is a core protein modulator developed by the company that effectively inhibits multiple genotypes of HBV and has no cross-resistance with NAs [2] - Currently, there are no approved core protein modulators for HBV globally, and compared to similar investigational drugs, TQA3605 shows superior safety and a more convenient once-daily oral administration, potentially providing a new treatment option for chronic HBV-infected patients [2]

Core Insights - China Biologic Products (01177.HK) announced the completion of Phase II clinical trials for its self-developed innovative drug TQA3605, a core protein allosteric modulator (CpAM), targeting chronic hepatitis B virus (HBV) infection patients, achieving its primary endpoint [1] Group 1: Clinical Trial Details - The study was a randomized, double-blind, placebo-controlled, multi-center Phase II trial (NCT06644417) aimed at evaluating the efficacy and safety of TQA3605 in combination with nucleos(t)ide analogs (NAs) in chronic HBV patients with low viral load [1] - A total of 122 subjects were enrolled, divided into a placebo group and multiple dosage groups of TQA3605, administered orally once daily [1] Group 2: Efficacy Results - Results indicated that among adult HBV patients who had received NAs treatment for at least 12 months, the combination therapy of TQA3605 and NAs for 24 weeks significantly increased the proportion of subjects with HBV DNA below the lower limit of quantification (<20 IU/mL), with nearly 90% in all dosage groups, significantly outperforming the NAs monotherapy control group (p < 0.0001) [1] Group 3: Safety Profile - The overall safety profile of TQA3605 was found to be good, with the incidence of adverse reactions comparable to the control group, and most treatment-emergent adverse events (TEAEs) were of grade 1-2, with no new safety signals observed [1] - Detailed study results are expected to be presented at upcoming international academic conferences [1]

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 TQA3605「核心蛋白變構調節劑」慢性乙型肝炎二期取得積極進展 該研究是一項隨機、雙盲、安慰劑對照、多中心二期研究(NCT06644417)，旨在評價TQA3605聯合 核甘（酸）類藥物(NAs)在經治的低病毒血症的慢性HBV感染受試者中的有效性和安全性。該研究共入 組122例受試者，分為安慰劑對照組及多個不同劑量TQA3605試驗組，給藥方式為每日一次口服。 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類創新藥TQA3605片「核心蛋白變構調節劑(CpAM)」已於近日完成針對慢性乙型肝炎 病毒(HBV)感染患者的二期臨床試驗，並達到主要終點。 中國生物製藥有限公司 中國現有約8600萬HBV攜帶者，其中慢性HBV感染 ...

Core Viewpoint - China National Pharmaceutical Group (stock code: 01177.HK) announced the acquisition of Hegia Biotech for a total consideration of 1.2 billion RMB, marking a strategic move into the siRNA innovation drug sector [1][7] Group 1: Acquisition Details - The acquisition will be financed through a combination of cash and equity, with approximately 1.1 billion RMB paid in cash and the remaining 97 million RMB through the issuance of new shares at HKD 6.66 per share [1][7] - Following the transaction, Hegia will become a wholly-owned subsidiary of China National Pharmaceutical Group, integrating its R&D pipeline and technology platform into the company's chronic disease treatment strategy [1][7] Group 2: Hegia Biotech Overview - Founded in 2018, Hegia has emerged as a "dark horse" in the domestic siRNA field, leveraging its proprietary multi-organ targeted delivery technology [2][8] - Hegia's key advantages include a clinically validated liver delivery platform capable of "once-a-year" dosing, a dual-chain conjugation technology platform, and a neural delivery platform [2][8] - Hegia currently has four clinical-stage projects and over 20 preclinical projects, with the most advanced being Kylo-11, which targets lipoprotein(a) and has initiated a multi-center Phase II clinical trial in October 2025 [2][8] Group 3: Market Context and Valuation - The global market for siRNA is projected to reach USD 15 billion, with no approved targeted drugs currently available, indicating a pressing clinical need [2][8] - The acquisition valuation of 1.2 billion RMB corresponds to an 18.75x market cap/research spending ratio based on Hegia's R&D expenditure for 2024, which is considered low compared to similar overseas companies [3][9] - The acquisition is seen as a strategic move to fill gaps in China National Pharmaceutical Group's cardiovascular treatment portfolio and create synergies with existing chronic disease pipelines [2][3][9] Group 4: Financial Strength and Industry Trends - As of June 2025, China National Pharmaceutical Group had over 30 billion RMB in cash and liquid assets, providing a solid foundation for ongoing investments in innovative drugs [4][10] - The siRNA sector has become a focal point for global pharmaceutical companies, with a total transaction volume of USD 35 billion in 2025, reflecting a 40% year-on-year growth [4][10] - The competitive landscape includes established international players like Alnylam, which has a market cap exceeding USD 50 billion, and domestic companies like Reebio, which recently went public [4][10] Group 5: Challenges and Future Prospects - The acquisition faces challenges, including Hegia's core pipelines being in early to mid-clinical stages, requiring lengthy R&D and approval processes [5][12] - Hegia's external delivery technologies have not yet been clinically validated, and scaling production of siRNA drugs remains an industry bottleneck [5][12] - Despite these challenges, the acquisition's synergy potential is significant, as China National Pharmaceutical Group's industrial capabilities could help Hegia navigate the "valley of death" in biotech [6][12]