智通财经获悉，康方生物(09926)再涨超3%，截至发稿，涨3.83%，报121.9港元，成交额2.71亿港元。 消息面上，据康方生物官微消息，近日，公司宣布，全球首创的PD-1/CTLA-4双特异性抗体卡度尼利单 抗联合化疗，对比化疗联合或不联合纳武利尤单抗，用于HER2阴性、未经治疗的不可切除或转移性胃 或胃食管结合部腺癌一线治疗的国际多中心Ⅲ期临床研究(COMPASSION-37/AK104-311)，已获得美国 食品药品监督管理局(FDA)批准开展。 据悉，COMPASSION-37研究是卡度尼利第二个国际多中心注册性临床研究。此前，卡度尼利方案治疗 免疫耐药肝细胞癌的国际注册性临床研究已经在美国开展。COMPASSION-37研究的开展是卡度尼利的 全球化开发向前再迈出的关键性一步，也是康方生物全球化战略的重要举措，将有力巩固公司在肿瘤免 疫2.0 领域的国际领先地位。 本文源自：智通财经网 ...

Core Viewpoint - 康方生物's stock has increased by over 3%, currently trading at 121.9 HKD with a transaction volume of 271 million HKD, following the announcement of FDA approval for its innovative PD-1/CTLA-4 bispecific antibody, 卡度尼利单抗, for a pivotal clinical trial [1] Group 1: Company Developments - 康方生物 announced the initiation of the COMPASSION-37/AK104-311 international multicenter phase III clinical study, which evaluates 卡度尼利单抗 in combination with chemotherapy for HER2-negative, untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma [1] - This study represents the second international multicenter registration clinical trial for 卡度尼利, following a previous study focused on immune-resistant hepatocellular carcinoma that has already commenced in the United States [1] - The launch of the COMPASSION-37 study is a significant step forward in the global development of 卡度尼利 and is a key initiative in 康方生物's globalization strategy, reinforcing its leading position in the field of tumor immunotherapy 2.0 [1]

Core Viewpoint - 康方生物's stock has increased by over 3%, currently trading at 121.9 HKD with a transaction volume of 271 million HKD, following the announcement of FDA approval for its innovative PD-1/CTLA-4 bispecific antibody,卡度尼利单抗, for a pivotal clinical trial [1] Group 1 - 康方生物 announced the FDA approval for the international multicenter phase III clinical study (COMPASSION-37/AK104-311) of 卡度尼利单抗 in combination with chemotherapy for HER2-negative, untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma [1] - The COMPASSION-37 study is the second international multicenter registration clinical study for 卡度尼利单抗, following a previous study for immune-resistant hepatocellular carcinoma [1] - The initiation of the COMPASSION-37 study marks a significant step forward in the global development of 卡度尼利单抗 and is a key initiative in 康方生物's globalization strategy, reinforcing its leading position in the tumor immunotherapy 2.0 field [1]

Core Viewpoint - The company, Weili Zhibo, has emerged as a standout player in the Hong Kong IPO wave for innovative drug companies, successfully raising nearly 1.4 billion HKD after its stock price doubled on the first day of trading, marking it as the "first TCE stock" [1] Group 1: Company Overview - Weili Zhibo is a tumor immunotherapy company based in Nanjing, Jiangsu, with 14 candidate drugs, 6 of which are in clinical trial stages [1] - The company aims to submit 5 new drug IND applications by 2026, focusing on expanding its key pipeline drug LBL-024 to treat 8-10 tumor indications, including non-small cell lung cancer and melanoma [1][2] Group 2: Drug Development Strategy - The founder emphasizes the importance of differentiation in the competitive tumor treatment field, aiming to develop unique drugs that address unmet patient needs [1][2] - LBL-024 targets PD-L1 and 4-1BB, attempting to conditionally activate 4-1BB to convert "cold tumors" into "hot tumors," thereby enhancing T-cell response [3][4] - The drug's clinical trial data shows a significantly lower incidence of liver toxicity compared to traditional 4-1BB agonists, with 175 patients enrolled in trials as of June this year [5] Group 3: Clinical Progress and Future Plans - The company has reported promising results for LBL-024 in treating small cell lung cancer, with an objective response rate of 86.5% and a disease control rate of 96.2% in a small sample [7] - Plans are in place to initiate Phase II clinical trials for LBL-024 in multiple indications, including non-small cell lung cancer and cholangiocarcinoma, while employing an efficient trial strategy to minimize costs [7][8] Group 4: Financial Strategy and Market Position - The company has successfully raised funds during favorable market conditions, increasing its fundraising target significantly to support ongoing research and development [10] - Collaborations and partnerships are seen as crucial for cash flow, with the company having previously partnered with BeiGene and currently seeking new collaborations to enhance the value of its drug pipelines [10][12] Group 5: Pipeline and Future Innovations - In addition to LBL-024, the company is developing LBL-034, a TCE targeting GPRC5D for treating relapsed/refractory multiple myeloma, which has shown a high objective response rate of 90% in clinical trials [11] - The company is focused on improving research efficiency and maintaining a stable development team to drive innovation in a competitive market [12]

Group 1 - Nanjing Weilizhibo Biotechnology Co., Ltd. officially listed on the Hong Kong Stock Exchange, becoming the third Nanjing company to go public this year, raising the total number of listed companies in Nanjing to 165 [1][2] - Weilizhibo focuses on the discovery, development, and commercialization of new therapies for tumors, autoimmune diseases, and other major diseases, with a pipeline of 12 products including monoclonal antibodies and antibody-drug conjugates [2][3] - The company has developed proprietary technology platforms such as LeadsBodyTM and X-bodyTM, which optimize the balance between efficacy and safety, aiming to improve patient quality of life [2][3] Group 2 - The company raised $189 million, which will be primarily used for clinical drug development, optimizing technology platforms, and increasing production capacity [3] - Weilizhibo has established a first-mover advantage in the solid tumor treatment market with a differentiated T-cell engager (TCE) product matrix covering hematological tumors, solid tumors, and autoimmune diseases [3] - Following Weilizhibo's listing, Nanjing's capital market is set to expand further with another company, Hansan (Nanjing) Technology Co., Ltd., expected to go public next month, increasing the total to 166 listed companies [4][5]

Group 1: Yimutian Inc. (一亩田) - Yimutian Inc. plans to go public on NASDAQ under the ticker "YMT" with an expected IPO date at the end of July 2023, aiming to raise up to $26 million by issuing 4.522 million American Depositary Shares (ADS) priced between $4.10 and $5.00 each [3][4] - Established in 2011, Yimutian has evolved from an information service platform to a comprehensive digital agriculture enterprise, serving over 56 million users and covering more than 340 cities and 2,800 counties in mainland China, capturing over 65% of the primary and secondary agricultural wholesale market [4] - The company has developed a new offline store model called "沃来采" to meet the needs of emerging buyers, leveraging its extensive buyer channels and market data to provide standardized and efficient agricultural brokerage services [4][5] Group 2: Weili Zhizhi Bio (维立志博) - Weili Zhizhi Bio officially listed on the Hong Kong Stock Exchange under the ticker "9887" on July 25, 2025, raising approximately HKD 1.29 billion by issuing 36,862,500 shares at an offer price of HKD 35.00 each [7][8] - The company attracted nine cornerstone investors, securing a total of USD 69 million (approximately HKD 541.6 million) in subscriptions, with notable contributions from firms like Tencent and various investment funds [8] - As a clinical-stage biotechnology company founded in 2012, Weili Zhizhi focuses on discovering and commercializing new therapies for cancer and autoimmune diseases, boasting a diverse product portfolio of 14 innovative candidates, including four core products that are leading in global clinical progress [9]