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 安全性數據：3級及以上治療相關不良事件(TRAEs)主要包括中性粒細胞減少(23.3%)、白細胞減少 (20.6%)、貧血(8.2%)和低鉀血症(6.9%)等，總體耐受性良好。 乳腺癌是全球女性最常見的惡性腫瘤，2022年中國乳腺癌新發病例數約35.7萬例，死亡病例數約7.5 萬例[2]。其中，約45%-55%的乳腺癌為HER2低表達（即HER2 IHC 1+或2+/FISH-）。這類患者形成了 一個異質性群體，現有的常規靶向HER2療法對其臨床獲益有限，亟需新的治療手段改善預後[3-4]。 在乳腺癌治療領域，本集團已佈局HER2+、HER2低表達、HR+/HER2－及三陰性乳腺癌在內的全分 子分型，並系統覆蓋從新輔助、一線、二線及以上、到輔助治療的全病程治療階段，致力於為更多 患者提供新 ...

智通财经APP获悉，中国生物制药(01177)涨超3%，截至发稿，涨3.09%，报6.68港元，成交额1.49亿港 元。 消息面上，2月9日，中国生物制药发布公告，集团全资附属公司礼新医药科技(上海)有限公司(礼新医 药)自主研发的国家1类创新药维特柯妥拜单抗(研发代号：LM-302)"CLDN18.2 ADC"正在开展用于治疗 三线及以上CLDN18.2阳性的局部晚期或转移性胃及胃食管交界部腺癌的III期注册临床试验(LM302-03- 101)，已顺利完成患者入组。其中，LM302是全球首款完成注册III期临床试验入组的CLDN18.2 ADC药 物。 在2025年美国临床肿瘤学会(ASCO)年会上，礼新医药公布了LM-302联合特瑞普利单抗治疗胃癌的最新 研究数据：在41例疗效可评估的患者中，客观缓解率(ORR)为65.9%，疾病控制率(DCR)为 85.4%。其 中，在CLDN18.2表达≥25%的32例患者中，ORR达到71.9%，DCR达到96.9%。按PD-L1 表达分层分 析，PD-L1 CPS<1的患者ORR为63.3%，CPS≥1的患者ORR为77.8%。该研究表明，LM302联合治疗方案 ...

Core Viewpoint - China Biologic Products (01177) announced that its wholly-owned subsidiary, Lixin Pharmaceutical Technology (Shanghai) Co., Ltd., has initiated a Phase III registration clinical trial for its self-developed innovative drug, LM-302, targeting CLDN18.2-positive advanced gastric and gastroesophageal junction adenocarcinoma [1][2]. Group 1: Clinical Development - LM-302 is the first CLDN18.2 antibody-drug conjugate (ADC) to complete patient enrollment in a Phase III clinical trial globally [1]. - The drug specifically targets CLDN18.2-positive tumor cells, delivering a small molecule toxin to achieve precise tumor cell destruction [1]. - The ongoing Phase III trial focuses on patients with locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma who have received three or more prior lines of therapy [2]. Group 2: Clinical Results - At the 2025 American Society of Clinical Oncology (ASCO) annual meeting, Lixin Pharmaceutical reported that in 41 evaluable patients, the objective response rate (ORR) was 65.9% and the disease control rate (DCR) was 85.4% [2]. - Among 32 patients with CLDN18.2 expression ≥25%, the ORR reached 71.9% and the DCR was 96.9% [2]. - The study also indicated that for patients with PD-L1 CPS <1, the ORR was 63.3%, while for those with CPS ≥1, the ORR was 77.8% [2]. Group 3: Future Plans and Regulatory Status - In addition to the ongoing Phase III study, LM-302 is set to undergo another Phase III registration trial in China, focusing on first-line treatment for CLDN18.2-positive locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma [2]. - LM-302 has been included in the breakthrough therapy designation by the China National Medical Products Administration (NMPA) and has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) [2]. Group 4: Company Strategy - Leveraging strong resources and industrial capabilities, Lixin Pharmaceutical is accelerating the clinical translation and commercialization of more innovative drugs, aiming to provide accessible treatment options for global cancer patients [3].

智通财经APP讯，中国生物制药(01177)发布公告，集团全资附属公司礼新医药科技(上海)有限公司(礼新 医药)自主研发的国家1类创新药维特柯妥拜单抗(研发代号：LM-302)"CLDN18.2 ADC"正在开展用于治 疗三线及以上CLDN18.2阳性的局部晚期或转移性胃及胃食管交界部腺癌的III期注册临床试验(LM302- 03-101)，已顺利完成患者入组。其中，LM302是全球首款完成注册III期临床试验入组的CLDN18.2 ADC 药物。 LM-302是一款靶向CLDN18.2的抗体偶联药物(ADC)，通过与CLDN18.2阳性肿瘤细胞特异性结合，并 经内吞作用进入细胞后释放小分子毒素，从而实现对肿瘤细胞的精准杀伤。作为潜在同类首创 (FIC)药 物，LM-302在胃癌、胰腺癌及胆道癌等多个消化道肿瘤中展现出良好的临床开发潜力，并有望为 CLDN18.2低表达和PD-L1低表达患者提供新的治疗选择。 在2025年美国临床肿瘤学会(ASCO)年会上，礼新医药公布了LM-302联合特瑞普利单抗治疗胃癌的最新 研究数据：在41例疗效可评估的患者中，客观缓解率(ORR)为65.9%，疾病控制率(DCR)为 ...

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]