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，並明確表示概不就因本公告全部或任何部分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。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （股份代號：2696） （於中華人民共和國註冊成立的股份有限公司） C. 關於HLX37 HLX37是本公司自主研發的重組人源化抗PD-L1與抗VEGF雙特異性抗體， 擬用於治療晚期/轉移性實體瘤。HLX37可同時作用於兩個不同的靶點，其作 用機制結合了兩種治療路徑：(1)阻斷PD-1/PD-L1信號通路：通過阻斷腫瘤 細胞表面PD-L1與T細胞表面的PD-1結合，解除腫瘤免疫抑制作用，從而恢 復T細胞對腫瘤的殺傷能力；(2)阻斷血管生成通路：通過抑制VEGF與其受 體結合，減少腫瘤血管生成，從而限制腫瘤的生長和轉移。這種雙靶點設計 可能產生協同抗腫瘤效應，並可能降低耐藥性風險。通過特異性結合腫瘤細 胞PD-L1實現腫瘤內部HLX37雙抗分子的富集，實現大於抗PD-L1單抗和抗 VEGF單抗的聯合療效。臨床前研 ...

Core Viewpoint - Johnson & Johnson's innovative treatment drug Evotaz (Avenatuzumab injection) has received approval from China's NMPA for treating advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations, marking a significant advancement in cancer treatment in China [1][2] Group 1: Product Approval and Benefits - The approval of Avenatuzumab injection provides a more convenient administration method, reducing the administration time from several hours to approximately 5 minutes [1] - Compared to intravenous formulations, the incidence of infusion-related adverse reactions is reduced by 80% [1] - The product utilizes Halozyme's ENHANZE® drug delivery technology, which includes recombinant human hyaluronidase (rHuPH20) [1] Group 2: Market Impact and Patient Needs - Approximately 40% of lung cancer patients in China carry EGFR mutations, indicating a significant unmet medical need within this patient population [2] - The approval of Avenatuzumab injection is seen as a milestone, reinforcing its important role in the treatment of EGFR mutation-positive NSCLC [2] - The new subcutaneous formulation offers greater convenience for patients and clinicians, improving tolerability while maintaining efficacy and manageable safety [2]

Nanjing Leads Biolabs Co., Ltd. 南 京 維 立志博生物科技股份有限公司 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 中 華 人 民 共 和 國 成 立 的 股 份 有 限 公 司） （股 份 代 號：9887） 自願公告 LBL-024於鉑耐藥卵巢癌IB/II期試驗的首例患者用藥 本公告由南京 維 立志博生物科技股份有限公司（「本公司」，連 同 其 附 屬 公 司 統 稱「本集團」）自 願 作 出，以 告 知 本 公 司 股 東 及 潛 在 投 資 者 有 關 本 公 司 的 最 新 業 務 發 展 情 況。 本 公 司 欣 然 宣 布，評 價 奧 帕 替 蘇 米 單 抗（PD-L1/4-1BB雙特異性抗體LBL-024）用 於治療鉑耐藥卵巢癌的Ib/II期 臨 床 研 究 首 例 患 者 已 成 功 用 藥。 關 於LBL-024 LBL-024是一種 ...

Core Insights - The company, founded in 2015 by Wu Chenbing, focuses on the development of bispecific antibodies, particularly T cell engagers (TCEs), which are considered next-generation technologies in tumor immunotherapy [3] - The company has developed a proprietary bispecific antibody technology platform and has a pipeline that includes eight investigational drugs, none of which have reached commercialization as of June 2025 [3] - The company faces significant uncertainty in its core business, with low probabilities of success for drug development, particularly in the complex field of oncology [4] Financial Overview - As of the end of 2024, the company has accumulated losses of 2.355 billion yuan, with R&D expenditures of 185 million yuan and 123 million yuan in 2023 and 2024, respectively [4] - The total operating expenses for these two years reached 235 million yuan and 166 million yuan, respectively [4] - The company has raised approximately 234.5 million USD (about 1.577 billion yuan) through six rounds of financing, with a post-money valuation of 492 million USD (about 3.311 billion yuan) [4] IPO Plans - The company plans to use the funds raised from its IPO primarily to advance clinical trials for its core product EMB-01 and key products EMB-06 and EMB-07, as well as other investigational pipelines [5] - Successful listing is crucial for the company not only to secure valuable R&D funding but also to provide an exit channel for early investors and alleviate the pressure from redeemable preferred shares [5]

Core Viewpoint - The stock of Zai Lab Limited (荃信生物-B) rose over 4% following the announcement of a licensing agreement with Windward Bio's subsidiary, LE2025 Therapeutics AG, for the development and commercialization of QX027N outside of Greater China [1] Group 1: Licensing Agreement - Zai Lab has entered into a licensing agreement with LE2025 Therapeutics AG for its proprietary drug QX027N [1] - LE2025 is granted exclusive rights to develop and commercialize QX027N globally, excluding mainland China, Taiwan, Hong Kong, and Macau [1] - Zai Lab is entitled to receive up to $700 million in payments, which includes an upfront payment, equity from Windward Bio, and milestone payments related to development and commercialization [1] Group 2: Product Information - QX027N is a long-acting bispecific antibody targeting TSLP and IL-13, developed by Zai Lab [1] - The drug has received implied approval for clinical trials from the National Medical Products Administration (NMPA) in November 2025, with acceptance numbers CXSL2500757 and CXSL2500758 [1] - QX027N is intended for the treatment of asthma and atopic dermatitis, and the first subject has been enrolled in the domestic Phase I clinical trial [1]

Core Insights - The article discusses the IPO progress of Aimi Biotech, a pioneer in next-generation bispecific antibodies, focusing on its innovative T cell engagers (TCE) for cancer and autoimmune disease treatment [1][2]. Group 1: Company Overview - Aimi Biotech is at the forefront of the bispecific antibody treatment field, aiming to develop TCEs globally for various cancers and autoimmune diseases [1]. - The company plans to use the net proceeds from the IPO primarily for clinical development of core products, pipeline expansion, and operational funding [1]. - Aimi Biotech has a strong leadership team with extensive industry experience, including founder Dr. Wu Chenbing and Chief Medical Officer Dr. Zhu Yonghong, which supports its strategic execution and technology transfer [2]. Group 2: Technology and Product Pipeline - Aimi Biotech has developed proprietary technology platforms, including FIT-Ig, MAT-Fab, and a CD3 antibody library, which are crucial for advancing bispecific antibody development [2][3]. - The FIT-Ig platform is unique as it does not require amino acid mutations or linker peptides, with clinical projects like EMB-01 and EMB-06 already in advanced stages [3]. - The company has established seven product pipelines covering oncology and immunology, including key products EMB-01 for colorectal cancer, EMB-06 for multiple myeloma, and EMB-07 for lymphoma and solid tumors [2]. Group 3: Market Potential and Collaborations - The global bispecific antibody market is projected to reach $221.8 billion by 2034, with a compound annual growth rate (CAGR) of 32.4% from 2024 to 2034 [1]. - Aimi Biotech has secured multiple licensing agreements since the end of 2023, with a total transaction value exceeding $2.1 billion, ranking second globally in the TCE field [4]. - The company is positioned to accelerate the commercialization of innovative drugs, enhancing its competitive edge in the rapidly growing bispecific antibody and TCE treatment markets [4].

Core Viewpoint - The current focus in the Hong Kong stock market is on innovative drug companies, with limited incremental information available until companies disclose new data. However, there are still opportunities in U.S. biotech research and Hong Kong IPOs, particularly in studying prospectuses and new drug targets like ES014 from Kewang Pharmaceuticals [1]. Group 1: Drug Mechanism and Target - CD39 and CD73 are extracellular nucleotidases that play a critical role in purinergic signaling, catalyzing the hydrolysis of ATP to ADP and AMP, and further to adenosine, which contributes to immune regulation and tumor progression [1][2]. - In the tumor microenvironment (TME), CD39 and CD73 are expressed in various cell types, including tumor cells and immune cells, and they promote immune evasion by catalyzing ATP to adenosine [2]. Group 2: Clinical Data and Drug Development - The monoclonal antibody TTX-030 has shown promise in clinical trials, achieving an objective response rate (ORR) of 61% in a study involving 44 patients with HER2-negative gastric cancer [5]. - Kewang's ES014, a bispecific antibody targeting CD39 and TGFβ, has demonstrated potential in activating immune cells and inhibiting Treg cell differentiation, with a high ORR of 40% in a rare tumor type called desmoplastic tumor (DT) [10][11][12]. Group 3: Market Potential and Future Outlook - There is a significant unmet clinical need for effective treatments in DT, and if Kewang can establish ES014 in this indication, it could solidify the pipeline and potentially expand into larger indications, similar to the development path of other successful drugs [12].

Core Viewpoint - Rongchang Biologics (09995) experienced a significant stock increase, with a rise of over 7% during trading, closing at 81.5 HKD, with a transaction volume of 310 million HKD. This surge is attributed to the presentation of clinical trial data for their PD-1/VEGF bispecific antibody RC148 at the ESMO-IO conference in London, highlighting its promising efficacy in treating non-small cell lung cancer [1][1][1]. Group 1: Clinical Trial Data - The clinical trial data for RC148, presented at the ESMO-IO conference, showed a remarkable overall response rate (ORR) of 66.7% and a disease control rate (DCR) of 95.2% when combined with docetaxel at a dosage of 20 mg/kg every three weeks [1][1][1]. - Subgroup analysis revealed that patients with PD-L1 positive status (TPS≥1%) had an ORR of 80%, indicating significant efficacy across different patient groups [1][1][1]. - The median follow-up time for the trial was approximately 7 months, with a median progression-free survival (mPFS) of 8.3 months, further supporting the drug's potential effectiveness [1][1][1]. Group 2: Regulatory Approvals and Market Potential - RC148 received FDA approval to initiate Phase II clinical trials in the United States, marking a significant step in its global clinical development [1][1][1]. - Earlier in August, RC148 was also approved in China for clinical research in monotherapy and combination therapy for advanced solid tumors, showcasing its rapid progress in clinical development [1][1][1]. - The global business development (BD) activity surrounding PD-1/VEGF therapies is intensifying, with companies like Kangfang Biologics and 3SBio already pursuing international licensing agreements, indicating a competitive landscape and potential for RC148 to capitalize on this trend [1][1][1].

Core Viewpoint - The company, Wuxi Biologics-B (09887), has seen its stock rise over 3%, currently trading at 53.6 HKD, with a transaction volume of 51.26 million HKD, following the announcement of its participation in the 67th ASH Annual Meeting in December 2025, where it will present its promising dual-specific antibody LBL-034 for treating relapsed/refractory multiple myeloma (RRMM) [1] Group 1 - Wuxi Biologics-B will present LBL-034 at the 67th ASH Annual Meeting in Orlando, Florida, from December 6 to 9, 2025 [1] - LBL-034 has shown good safety and encouraging anti-tumor activity in its I/II clinical trials, particularly in high-risk refractory subgroups [1] - The clinical study of LBL-034 is led by Professor Lu Jin from Peking University People's Hospital and involves 17 centers across the country [1] Group 2 - According to Frost & Sullivan, as of November 2024, LBL-034 is the second in clinical progress globally for targeted GPRC5D CD3 T-cell engagers, following Johnson & Johnson, and is the leading one in China [1] - LBL-034 received orphan drug designation (ODD) from the FDA in October 2024 for the treatment of multiple myeloma [1]

Core Viewpoint - The company announced that its proprietary GPRC5D/CD3 bispecific antibody LBL-034 for treating relapsed/refractory multiple myeloma (RRMM) will be presented at the 67th ASH Annual Meeting in Orlando, Florida, from December 6 to 9, 2025, showcasing promising clinical results [1] Group 1: Clinical Highlights - LBL-034 demonstrated no dose-limiting toxicities (DLT) at doses up to 1,200 μg/kg, with the maximum tolerated dose (MTD) not reached [2] - The objective response rate (ORR) was 82.5% across a dose range of 400 to 1,200 μg/kg, with a complete response (CR) rate of 52.5% and a very good partial response (VGPR) rate of 72.5% [2] - In the 800 μg/kg dose group, ORR and CR rates were notably high at 90.9% and 63.6%, respectively [2] Group 2: Efficacy in Specific Patient Populations - Among patients with extramedullary disease (EMD), the ORR was 75.0%, with two cases achieving stringent complete response (sCR) [2] - In the 1,200 μg/kg dose group, patients with EMD showed a 100% ORR, with rapid shrinkage of EMD lesions observed [2] - For patients previously treated with BCMA-targeted therapies, the ORR was 85.7%, with a CR/sCR rate of 57.1% [2] Group 3: Progression-Free Survival - A sustained benefit trend was observed, with a 12-month progression-free survival (PFS) rate of 61.2% based on a median follow-up of 9.6 months [3] - In the 400 μg/kg group, the median follow-up time reached 13.1 months, showing a 12-month PFS rate of 56.8% [3]