Group 1 - The core viewpoint of the article is that China Biologic Products (01177) has completed the enrollment of subjects for the Phase III clinical trials of two drugs, TQB2102 and LM302 [1] - LM302 is noted as the world's first CLDN18.2 antibody drug complex to complete subject enrollment in Phase III registration clinical trials, potentially providing new treatment options for patients [1] - Bank of America Securities has set a target price of HKD 8.6 and reiterated a "Buy" rating for the company [1]

Core Viewpoint - Bank of America Securities reports that China Biologic Products (01177) has completed patient enrollment for Phase III clinical trials of two drugs, TQB2102 and LM302, with LM302 being the first CLDN18.2 antibody drug conjugate to complete such enrollment globally, potentially offering new treatment options for patients [1] Group 1 - China Biologic Products has completed patient enrollment for Phase III clinical trials of TQB2102 and LM302 [1] - LM302 is noted as the world's first CLDN18.2 antibody drug conjugate to finish Phase III registration clinical trial enrollment [1] - Bank of America Securities sets a target price of HKD 8.6 and maintains a "Buy" rating for the stock [1]

Core Viewpoint - Bank of America Securities reports that two drugs from a Chinese biopharmaceutical company, TQB2102 and LM302, have recently completed patient enrollment for Phase III clinical trials, with LM302 being the first CLDN18.2 antibody-drug conjugate to complete this phase globally, potentially offering new treatment options for patients [1] Group 1 - The two drugs, TQB2102 and LM302, have completed patient enrollment for Phase III clinical trials [1] - LM302 is noted as the world's first CLDN18.2 antibody-drug conjugate to complete Phase III registration clinical trial enrollment [1] - The target price for the company is set at HKD 8.6, with a reiterated "Buy" rating [1]

Core Viewpoint - China Biologic Products (01177.HK) has announced that its self-developed innovative drug TQB2102, a HER2 dual-target antibody-drug conjugate (ADC), is currently undergoing a Phase III clinical trial to evaluate its efficacy and safety compared to chemotherapy in HER2 low-expressing recurrent/metastatic breast cancer [1][2]. Group 1 - TQB2102 is a next-generation HER2 dual epitope bispecific antibody-drug conjugate developed by the company, which optimizes the balance between efficacy and safety through three core technological innovations [2]. - The first innovation is the dual epitope targeting design, which employs an asymmetric structural design for the antibody end, significantly enhancing selectivity for tumor cells and drug internalization efficiency, thereby increasing anti-tumor activity [2]. - The second innovation involves a cleavable linker that efficiently releases toxins and possesses a "bystander effect," which helps eliminate surrounding heterogeneous tumor cells, thus expanding the killing range [2]. - The third innovation is the optimized drug-antibody ratio (DAR), which is stably controlled between 5.8 and 6.0, combined with a topoisomerase I (Topo I) inhibitor toxin, enhancing efficacy while reducing side effects [2]. - The combination of these core technologies breaks through the limitations of traditional HER2 monoclonal antibodies and single-target ADCs, demonstrating significant potential for TQB2102 in treating HER2 low-expressing tumors [2].

Core Viewpoint - The company is advancing its self-developed innovative drug TQB2102, a HER2 dual-targeted antibody-drug conjugate (ADC), through a Phase III clinical trial to evaluate its efficacy and safety in patients with HER2 low-expressing recurrent or metastatic breast cancer [1][2] Group 1: Clinical Trial and Drug Development - TQB2102 is undergoing a randomized, open-label, parallel-controlled Phase III clinical trial (TQB2102-III-01) to compare its effectiveness against chemotherapy in HER2 low-expressing breast cancer [1] - The drug incorporates three core technological innovations: dual-target design, cleavable linker, and optimized drug-antibody ratio (DAR), enhancing its antitumor activity and safety profile [1] Group 2: Clinical Results - At the 2025 ASCO annual meeting, the company reported promising results from a Phase Ib clinical study of TQB2102 in HER2 low-expressing advanced breast cancer, showing an overall objective response rate (ORR) of 53.4% among previously treated patients [2] - Notably, in the 7.5 mg/kg group, the ORR reached 58.3%, and 44.4% of patients who had previously progressed on ADC treatment achieved a response after TQB2102 therapy [2] - The safety profile indicated that grade 3 or higher treatment-related adverse events (TRAEs) included neutropenia (23.3%), leukopenia (20.6%), anemia (8.2%), and hypokalemia (6.9%), with overall tolerability being good [2] Group 3: Market Positioning - The company has established a comprehensive portfolio in breast cancer treatment, covering various molecular subtypes including HER2+, HER2 low-expressing, HR+/HER2-, and triple-negative breast cancer, aiming to provide new treatment options across all stages of disease management [2]

Core Viewpoint - China Biologic Products (01177) is advancing its self-developed innovative drug TQB2102, a HER2 dual-target antibody-drug conjugate (ADC), through a Phase III clinical trial aimed at evaluating its efficacy and safety compared to chemotherapy in HER2 low-expressing recurrent/metastatic breast cancer patients [1][2] Group 1: TQB2102 Development and Clinical Trials - TQB2102 is designed using three core technological innovations to optimize efficacy and safety: dual-target design, cleavable linker, and optimized drug-antibody ratio (DAR) [1] - The Phase III clinical trial (TQB2102-III-01) has completed the enrollment of all participants [1] Group 2: Clinical Research Results - At the 2025 American Society of Clinical Oncology (ASCO) annual meeting, TQB2102 demonstrated a 53.4% overall objective response rate (ORR) in previously treated HER2 low-expressing patients, with a notable 58.3% ORR in the 7.5 mg/kg group [2] - Among patients who had previously progressed on ADC treatment, 44.4% achieved a response after TQB2102 therapy [2] - Safety data indicated that grade 3 or higher treatment-related adverse events (TRAEs) included neutropenia (23.3%), leukopenia (20.6%), anemia (8.2%), and hypokalemia (6.9%), with overall tolerability being good [2] Group 3: Market Positioning and Strategy - The company has established a comprehensive portfolio in breast cancer treatment, covering various molecular subtypes including HER2+, HER2 low-expressing, HR+/HER2-, and triple-negative breast cancer, addressing the entire treatment continuum from neoadjuvant to adjuvant therapy [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） 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 ...

Group 1 - China Biologic Products (01177) saw a stock increase of over 3%, reaching HKD 6.68 with a trading volume of HKD 149 million [1] - On February 9, China Biologic announced that its wholly-owned subsidiary, Lixin Pharmaceutical Technology (Shanghai) Co., Ltd., has initiated a Phase III registration clinical trial for its innovative drug, LM-302, targeting CLDN18.2 positive advanced gastric and gastroesophageal junction adenocarcinoma [1] - LM-302 is the first CLDN18.2 ADC drug globally to complete patient enrollment in a Phase III clinical trial [1] Group 2 - At the 2025 American Society of Clinical Oncology (ASCO) annual meeting, Lixin Pharmaceutical presented new research data showing an objective response rate (ORR) of 65.9% and a disease control rate (DCR) of 85.4% in 41 evaluable patients treated with LM-302 combined with Toripalimab for gastric cancer [2] - In patients with CLDN18.2 expression ≥25%, the ORR reached 71.9% and the DCR was 96.9% [2] - The study indicated significant anti-tumor activity and manageable safety profiles for the LM-302 combination therapy in CLDN18.2 positive patients [2]

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].

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 innovative drug, LM-302, targeting CLDN18.2 positive advanced gastric and gastroesophageal junction adenocarcinoma, marking it as the first CLDN18.2 ADC drug to complete patient enrollment in a Phase III trial [1][2]. Group 1 - LM-302 is an antibody-drug conjugate (ADC) that specifically targets CLDN18.2 positive tumor cells, delivering a small molecule toxin to achieve precise tumor cell destruction [1]. - The drug shows promising clinical development potential in various gastrointestinal tumors, including gastric cancer, pancreatic cancer, and cholangiocarcinoma, and aims to provide new treatment options for patients with low CLDN18.2 and PD-L1 expression [1][2]. - At the 2025 ASCO annual meeting, Lixin Pharmaceutical reported an objective response rate (ORR) of 65.9% and a disease control rate (DCR) of 85.4% in 41 evaluable patients, with even higher rates in patients with CLDN18.2 expression ≥25% [2]. Group 2 - In addition to the ongoing Phase III study for advanced gastric cancer, LM-302 is set to undergo another Phase III trial in China, combining it with PD-1 monoclonal antibodies for first-line treatment of CLDN18.2 positive advanced gastric cancer [2]. - Multiple indications for LM-302 have been designated as breakthrough therapies by the China National Medical Products Administration (NMPA) and have received orphan drug designation from the U.S. FDA [2]. - Lixin Pharmaceutical is accelerating the clinical transformation and commercialization of more innovative drugs, aiming to provide accessible treatment options for global cancer patients [3].