格隆汇9月30日丨复星医药(600196.SH)公布，公司控股子公司上海复宏汉霖生物技术股份有限公司及其控股子公司（以下合称"复宏汉霖"）收到国家药品监督管理局关于同意注射用HLX43（ 本次治疗方案中所涉HLX43为复宏汉霖利用许可引进的新型DNA拓扑异构酶I抑制剂小分子毒素-肽链连接子与其自主研发的靶向PD-L1的抗体进行偶联开发的靶向PD-L1的抗体偶联药物（ADC） ...

Core Viewpoint - HengRui Medicine has signed a licensing agreement with Glenmark Specialty for the innovative drug SHR-A1811, expanding its market reach and enhancing its global presence in cancer treatment [1][3]. Group 1: Licensing Agreement Details - The agreement allows Glenmark Specialty to license SHR-A1811, an antibody-drug conjugate targeting HER2, which is designed to induce apoptosis in tumor cells [1]. - Glenmark Specialty will pay an upfront fee of $18 million to HengRui, with potential milestone payments related to registration and sales reaching up to $1.093 billion [2]. Group 2: Clinical Development and Approvals - SHR-A1811 has received approval for use in adult patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 mutations, marking it as the first Chinese-developed ADC for this indication [1]. - Multiple clinical studies are ongoing, with SHR-A1811 receiving orphan drug designation from the FDA for use in gastric cancer and related conditions, and a new indication for breast cancer under priority review by the National Medical Products Administration [2]. Group 3: Strategic Implications - The agreement is expected to broaden the overseas market for SHR-A1811, providing high-quality treatment options for global patients and enhancing HengRui's innovative brand and international performance [3]. - The company aims to strengthen international cooperation while maintaining a focus on independent research and development, facilitating rapid transformation of research outcomes into marketable products [3].

9月23日，百奥赛图（02315.HK）发布消息称，公司授权给美国IDEAYA Biosciences公司的肿瘤治疗药 物IDE034项目取得阶段性进展。据介绍，该药物在肺癌、结直肠癌等癌种中显示治疗潜力，IDEAYA计 划于2024年四季度向美国监管部门提交临床试验申请。 IDE034是一款抗体偶联药物（ADC），采用双靶点设计，能够同时识别B7H3与PTK7两个肿瘤标志 物。该产品搭载百奥赛图的连接子与载荷平台BLD1102技术。 此前在2024年11月，百奥赛图将其B7H3/PTK7全人源双抗ADC项目授权给IDEAYA公司，潜在交易金额 接近30亿元人民币。若进展顺利，该项目有望成为该双靶点领域的首个临床阶段ADC产品。 IDE034基于百奥赛图的RenLite全人抗体共轻链平台开发。公司在双抗ADC领域还拥有RenNano平台， 可产生全人纳米抗体。百奥赛图依托其RenMice全人抗体小鼠平台建立了抗体分子库，为制药企业提供 研发服务。 在国际合作方面，百奥赛图在双抗ADC领域的合作伙伴包括SOTIO、ABL Bio、Radiance及ADC Therapeutics等。在抗体开发领域，公司与吉利德 ...

Core Insights - The 2025 World Lung Cancer Conference showcased significant advancements in innovative drugs from Chinese pharmaceutical companies, highlighting the increasing international recognition of Chinese innovation in the pharmaceutical sector [1][2]. Group 1: Company Achievements - Sichuan BaiLi TianHeng Pharmaceutical Co., Ltd. presented its groundbreaking EGFR×HER3 dual antibody ADC, iza-bren, which is the first of its kind to enter Phase III clinical trials globally [1][3]. - The clinical trials for iza-bren demonstrated a tumor shrinkage rate of 94% in patients with advanced EGFR-mutant non-small cell lung cancer (NSCLC), significantly outperforming existing treatments [2][3]. - BaiLi TianHeng has established a global strategic partnership with Bristol-Myers Squibb, with a total deal value of up to $8.4 billion, marking iza-bren as the first Chinese dual antibody ADC to enter international markets [4]. Group 2: Industry Trends - The number of approved innovative drugs in China has steadily increased, with 197 innovative drugs approved from 2018 to 2024, and the annual approval rate rising from 11 in 2018 to 48 in 2024 [3]. - Over 120 Chinese pharmaceutical companies are engaged in ADC research, contributing to a global pipeline of over 600 projects [2][3]. - The Chinese biopharmaceutical sector benefits from a growing number of biotech companies, a robust clinical research infrastructure, and an evolving regulatory environment that enhances the speed of drug approvals [6].

Group 1 - Heng Rui Medicine's subsidiary received the acceptance notice from the National Medical Products Administration for the marketing application of SHR-A1811, which is designed for HER2-positive breast cancer patients who have previously received one or more anti-HER2 therapies [1] - The approval process for SHR-A1811 has been prioritized, indicating its potential significance in the treatment landscape for breast cancer, particularly for HER2-positive patients [1] - The unique design of SHR-A1811 and its previous success in lung cancer treatment may allow it to carve out a new path in breast cancer therapy, enhancing treatment options for patients [1] Group 2 - Maiwei Biotech signed an exclusive licensing agreement with Kalexo for the 2MW7141 project, which could yield up to $1 billion in upfront and milestone payments, along with low single-digit royalties [2] - The collaboration is significant as the 2MW7141 project has broad prospects, potentially filling a market gap and providing new therapies for patients [2] - This partnership is expected to enhance Maiwei Biotech's profitability and international influence, although the high risks associated with biopharmaceutical development introduce uncertainties regarding the $1 billion payment [2] Group 3 - Kangfang Biotech's AK138D1, a novel antibody-drug conjugate targeting HER3, has received clinical trial approval in China, marking the company's first ADC to enter clinical stages [3] - HER3 is a popular target in cancer drug development, with expression in various malignancies, and AK138D1's unique design and progress in early clinical trials could offer new hope for patients with advanced malignancies [3] - Successful further trials of AK138D1 may enhance Kangfang Biotech's competitive position in the oncology market [3] Group 4 - Aikobio has submitted its listing application to the Hong Kong Stock Exchange, with J.P. Morgan and CITIC Securities as joint sponsors, focusing on therapies for respiratory and pediatric diseases [4] - The company has developed a pipeline of six candidate drugs, indicating good progress in its research and development efforts [4] - Although Aikobio has not yet turned a profit and faces significant R&D costs, a successful IPO could provide the necessary funding to support commercialization and enhance competitiveness in a challenging market [4]

Core Insights - Bailitianheng (688506.SH) has reached a new stock price high of 392.5 yuan, with a market capitalization of 157.39 billion yuan, following its partnership with Bristol-Myers Squibb (BMS) for the innovative drug Iza-bren [1] - The market is now focused on the approval timeline for Iza-bren's first indication and its potential breakthroughs in treating major cancers like lung cancer [1] - The company aims to become a leading entry-level multinational corporation (MNC) in the oncology field, requiring time and financial support [1] Product Development - Iza-bren (BL-B01D1) is expected to have two clinical data presentations at the 2025 World Conference on Lung Cancer (WCLC), including studies on its use as a monotherapy and in combination with Osimertinib for treating EGFR-mutant non-small cell lung cancer [2] - Iza-bren is the only EGFR×HER3 dual antibody ADC developed by Bailitianheng that has entered Phase III clinical trials [2] - The drug is currently involved in over 40 clinical trials in China and the U.S., with five indications included in the breakthrough therapy list by the National Medical Products Administration [3] Clinical Strategy - The company has initiated three new Phase II/III overseas key registration clinical trials this year, targeting triple-negative breast cancer, EGFR-mutant non-small cell lung cancer, and urothelial carcinoma [3] - Iza-bren's first potential indication for approval is for the treatment of end-stage nasopharyngeal carcinoma, with plans to submit a New Drug Application (NDA) if the interim analysis meets primary endpoints [4] Financial Overview - Bailitianheng's R&D expenses have significantly increased, with a 90.74% year-on-year rise to 1.039 billion yuan in the first half of the year, leading to a higher proportion of R&D spending relative to revenue [6] - The company anticipates a funding gap of approximately 4.819 billion yuan over the next three years, with plans to raise up to 3.764 billion yuan through a private placement [7] - The total investment in Iza-bren and other projects is projected to reach 4.353 billion yuan by the end of 2024 [6]

Core Viewpoint - The company, Maiwei Biotech, reported a significant decline in revenue and an increase in net losses for the first half of 2025, while also achieving notable milestones in business development (BD) partnerships and product approvals [1][4][6]. Financial Performance - In the first half of 2025, the company achieved revenue of 101 million yuan, a year-on-year decrease of 12.43%, and a net profit attributable to shareholders of -552 million yuan, with losses widening compared to the same period last year [1]. - The company's stock price reached a historical high of 50.36 yuan per share on August 29, 2023, with a year-to-date increase of over 137% [2]. Product Development and Approvals - The company has maintained a rhythm of approving one product annually since its listing on the STAR Market in 2022, with three products approved from 2022 to 2024, all of which are biosimilars [3]. - The first self-developed innovative drug, Mai Li Sheng (generic name: injection of Agrelin α), was approved in May 2023, marking a key step in the company's transition from biosimilars to innovative drugs [4][5]. Business Development Partnerships - The company has entered into significant BD collaborations, including a partnership with Qilu Pharmaceutical for the commercialization of Mai Li Sheng, which could yield up to 500 million yuan in milestone payments [4]. - Additionally, a licensing agreement with Calico for the IL-11 targeted therapy could result in up to 571 million USD in milestone payments and royalties based on net sales [5]. Research and Development Focus - The company has reported a cumulative loss of over 5.72 billion yuan over the past eight years, with R&D expenses in the first half of 2025 reaching 392 million yuan, an increase of 21.72% year-on-year, accounting for 388% of its revenue [8]. - The company is advancing multiple BD initiatives, emphasizing that 2025 will be a critical year for its innovative drug BD business [6]. Market Challenges - The company faces commercialization challenges for its biosimilars, with significant declines in expected shipments due to production capacity issues and market competition [4]. - The ADC (antibody-drug conjugate) sector is becoming increasingly competitive, prompting the company to explore new pipeline developments to maintain its market position [10].

Core Viewpoint - Mabwell (Shanghai) Bioscience Co., Ltd. is a biotechnology company focused on innovative drug development, with significant ongoing research and development (R&D) investments, but it is currently not profitable and faces potential risks related to its financial sustainability and operational challenges [1][2][3]. Company Overview - Mabwell has 14 key products in various stages of development, including 10 innovative drugs and 4 biosimilars, primarily targeting oncology and age-related diseases [1]. - The company reported R&D expenditures of 392.09 million yuan in the first half of 2025, a 21.72% increase compared to the same period last year [1]. Financial Performance - For the first half of 2025, the company generated operating revenue of approximately 101.17 million yuan, a decrease of 12.43% from the previous year [9]. - The total profit for the period was a loss of approximately 552.18 million yuan, compared to a loss of 444.34 million yuan in the same period last year [9]. - The net assets attributable to shareholders decreased by 47.86% to approximately 818.07 million yuan compared to the end of the previous year [9]. Industry Context - The global pharmaceutical market is expected to grow significantly, driven by factors such as aging populations, rising chronic disease rates, and increased R&D spending [11]. - The Chinese pharmaceutical market is projected to expand from 1.63 trillion yuan in 2024 to 2.48 trillion yuan by 2032, with a compound annual growth rate (CAGR) of 7.3% [11]. - The oncology drug market is also experiencing rapid growth, with the global market expected to reach approximately 375.9 billion USD by 2028 [13][14]. Regulatory Environment - Recent reforms in China's drug approval processes are aimed at accelerating the development and approval of innovative drugs, which may benefit companies like Mabwell [11]. - The introduction of national centralized procurement for biosimilars may pose challenges to profitability but could also increase market share for these products in the long term [12].

此外，康宁杰瑞制药自主研发的程序性死亡配体1（PD-L1）/整合素αvβ6双特异性抗体偶联药物 （ADC）JSKN022的新药临床试验申请已获中国国家药品监督管理局药品审评中心正式受理。公司计划 开展用于治疗晚期恶性实体瘤的JSKN022首次人体临床研究。目前全球范围内尚无靶向整合素αvβ6或 PD-L1的ADC上市，相关在研药物均处于临床研究阶段。 消息面上，康宁杰瑞制药将于8月28日(下周四)召开董事会会议以审批中期业绩。公司此前预计，上半 年取得利润不少于人民币2000万元，去年同期亏损约人民币4490万元。公司于报告期内转亏为盈，主要 基于三项授权合作的里程碑收入和商业化产品的销售收入。 智通财经APP获悉，康宁杰瑞制药-B(09966)尾盘涨幅进一步扩大，截至发稿，涨14.03%，报10.81港 元，成交额7386.46万港元。 ...

公开资料显示，GQ1005是启德医药基于独创的酶促定点偶联技术开发的靶向HER2的创新ADC药物。 临床前研究显示，GQ1005在多个肿瘤细胞系异种移植模型中展现出与德曲妥珠单抗相当的抗肿瘤活 性，且安全性优势明显。据悉，乳腺癌是复宏汉霖重点布局的核心治疗领域，公司已建立覆盖乳腺癌全 病程、全分子亚型的多元化产品管线，通过自建商业化团队和携手海外合作伙伴，组建了覆盖全球的商 业化网络，持续释放乳腺癌管线的商业价值。 智通财经APP获悉，复宏汉霖(02696)午后涨超8%，高见85.95港元再创新高，截至发稿，涨6.14%，报 83.85港元，成交额9514.09万港元。 消息面上，复宏汉霖近日宣布，与启德医药达成战略合作。根据约定，复宏汉霖将获得由启德医药开发 的创新HER2靶向抗体偶联药物（ADC）GQ1005在中国及特定海外国家和地区开发和独家商业化权 益。目前，该药物处于III期临床研究阶段，拟用于治疗HER2阳性乳腺癌。 ...