Core Insights - Zymeworks Inc. announced the conditional approval of zanidatamab by the National Medical Products Administration (NMPA) in China for treating previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC), marking it as the first dual HER2-targeted bispecific antibody approved for this indication in China [1][10] - The approval is a significant advancement for patients with HER2-positive BTC, a group with high unmet medical needs and poor prognoses, and reflects the clinical potential of zanidatamab [2][4] - Zymeworks has received $61 million in upfront and milestone payments from its collaboration partner BeOne Medicines, with an additional $20 million milestone payment linked to the NMPA approval and potential for up to $144 million in further milestones [2][6] Company Overview - Zymeworks is a clinical-stage biotechnology company focused on developing multifunctional biotherapeutics for difficult-to-treat diseases, including cancer, inflammation, and autoimmune diseases [1][6] - The company utilizes its proprietary Azymetric™ technology to engineer and develop zanidatamab, which targets HER2 and induces various mechanisms leading to tumor growth inhibition [5][7] - Zymeworks has strategic partnerships with BeOne Medicines and Jazz Pharmaceuticals, granting exclusive rights for the development and commercialization of zanidatamab in different territories [7] Industry Context - Biliary tract cancers account for approximately 3% of all digestive system tumors, with a rising incidence rate globally, particularly in Asia [4] - Approximately 11%-25.2% of patients with BTC are HER2-positive, making HER2 a validated target for antitumor therapy [4] - Zanidatamab has also received FDA approval in the U.S. and is under regulatory review in the EU, indicating its potential as a best-in-class treatment for HER2-expressing cancers [3][7]

Core Insights - Baiyue Shenzhou's bispecific HER2 inhibitor, Zhenidamab (百赫安), received conditional approval from the National Medical Products Administration (NMPA) for treating HER2-positive advanced or metastatic biliary tract cancer (BTC) patients who have previously undergone systemic therapy [1][2] - This approval marks Zhenidamab as the first and only bispecific antibody approved in China for targeted therapy of HER2-positive biliary cancer, providing a new treatment option for patients [1][2] - The incidence of biliary tract cancer is on the rise, with approximately 15% to 30% of BTC patients exhibiting HER2 abnormalities, making HER2 a key target for BTC treatment [1] Clinical Data - The conditional approval is based on the results of the global multicenter clinical study HERIZON-BTC-01, which showed an objective response rate (ORR) of 51.6% in previously treated, unresectable HER2-positive advanced or metastatic BTC patients [2] - The median duration of response (mDoR) was 14.9 months, and the median overall survival (mOS) was 18.1 months, indicating a significant improvement in survival compared to previous second-line chemotherapy options [2] - The safety profile of Zhenidamab was reported to be favorable, demonstrating good overall safety [2] Mechanism of Action - Zhenidamab utilizes a dual-targeting mechanism by binding to two different non-overlapping epitopes of the HER2 protein, enhancing its binding and inhibitory capabilities, which may lead to a synergistic effect in tumor suppression [2] - This innovative mechanism allows for dual signal blockade and the formation of larger receptor clusters, potentially improving therapeutic efficacy [2] Strategic Collaboration - Zhenidamab was developed by Zymeworks, with Baiyue Shenzhou entering a strategic partnership for its development and commercialization in Asia (excluding Japan), Australia, and New Zealand [3] - The drug is also set to be available in the United States, having received FDA approval for the same indication in November 2024 [3] - The President and COO of Baiyue Shenzhou expressed confidence that this innovative drug will significantly benefit the survival of BTC patients in China [3]

Core Insights - Chinese innovative pharmaceutical company 3SBio has entered a record-breaking License out agreement with Pfizer, potentially worth up to $60.5 billion (approximately 435 billion RMB) [1] - This transaction sets a new record for the amount of a single product going overseas from a Chinese pharmaceutical company and highlights the strong emergence of Chinese innovative drug companies in the global bispecific antibody market [1] Transaction Details - The agreement grants Pfizer the rights to develop, produce, and commercialize 3SBio's self-developed PD-1/VEGF bispecific antibody SSGJ-707 in global markets outside mainland China [2] - Pfizer will pay an upfront fee of $12.5 billion (approximately 90 billion RMB) and up to $4.8 billion in milestone payments, along with a double-digit percentage tiered revenue share from sales in the licensed regions [2] - All payments are non-refundable and non-offsettable, and Pfizer retains the option to commercialize the product in mainland China [2] Product Advantages - SSGJ-707 is developed based on 3SBio's proprietary CLF2 platform, featuring a common light chain symmetrical design and IgG-like structure, which significantly reduces production costs and enhances efficiency [3] - Clinical data shows promising anti-tumor activity and safety: - Objective response rate (ORR) of 70.8% and disease control rate (DCR) of 100% for PD-L1 positive non-small cell lung cancer (NSCLC) [3] - ORR of 81.3% for squamous NSCLC and 58.3% for non-squamous NSCLC, with DCR at 100% when combined with chemotherapy [3] - Adverse event rates for grade 3 or higher treatment-related adverse events (TRAE) range from 8.9% to 23.5%, significantly lower than similar products [3] Market Outlook - The PD-1/VEGF bispecific antibody market is expected to explode, with Evaluate Pharma predicting a global market size exceeding $80 billion by 2030 [5] - Currently, only Kangfang Biotech's Ivosidenib is on the market, and 3SBio's rapid advancement positions it to seize market opportunities [5] Industry Trends - The total value of License out transactions for Chinese innovative drugs reached $51.9 billion in 2024, a year-on-year increase of 27.4%, accounting for 30% of global similar transactions [6] - In the first quarter of 2025, Chinese companies completed 41 overseas transactions totaling over $36.9 billion, with a growing proportion of "heavyweight transactions" [6] - This collaboration further confirms the transition of Chinese innovative drug companies from "followers" to "leaders" in the global market [6] Industry Outlook - This transaction not only brings substantial cash flow to 3SBio but also highlights the maturity of Chinese pharmaceutical companies in target selection, clinical design, and international collaboration [7] - As more original Chinese drugs enter the global market, the "two-way rush" between multinational and Chinese pharmaceutical companies may become the new norm, accelerating the gathering of global pharmaceutical innovation resources in China [7] Conclusion - The collaboration between 3SBio and Pfizer marks a significant milestone for Chinese innovative drugs going global, transitioning from "Made in China" to "Created in China" [8] - With support from policies, capital, and technological breakthroughs, Chinese pharmaceutical companies are entering a golden era of License out, potentially reshaping the global pharmaceutical market landscape [8]

此前，IBI363已被CDE纳入突破性治疗药物（BTD）品种名单，拟定适应症为既往未经过系统性治疗的 不可切除局部晚期或转移性肢端型及黏膜型黑色素瘤。 信达生物正在中国、美国、澳大利亚开展临床研究探索IBI363在针对各种恶性肿瘤的有效性和安全性。 IBI363已开出首个关键注册临床研究，用于治疗未经免疫治疗的粘膜型和肢端型黑色素瘤。IBI363已获 美国FDA两项快速通道资格认定，分别用于治疗晚期鳞状非小细胞肺癌和黑色素瘤。 由于新激活的肿瘤特异性T细胞同时表达PD-1和IL-2α，这一差异性策略可以更精确和有效地实现对该T 细胞亚群的靶向和激活。IBI363不仅在多种荷瘤药理学模型中展现出了良好抗肿瘤活性，在PD-1耐药和 转移模型中也表现出了突出的抑瘤效力。 智通财经APP获悉，5月23日，国家药品监督管理局（NMPA）药品审评中心（CDE）官网显示，信达 生物（01801）的PD-1/IL-2双特异性抗体融合蛋白IBI363拟纳入突破性疗法，用于治疗经含铂化疗及抗 PD-1/PD-L1免疫治疗失败的局部晚期或转移性鳞状非小细胞肺癌。 据悉，IBI363是由信达生物自主研发的全球首创PD-1/IL-2α ...

Group 1 - The stock of Sanofi Guojian (688336) experienced a significant drop of over 10% during trading on the 23rd, following a continuous rise of 100% over the previous four trading days [1] - The company issued a risk warning on May 22, indicating the potential for irrational speculation and a market correction due to the substantial increase in stock price [1] - The trading volume exceeded 530 million yuan, reflecting heightened market activity [1] Group 2 - The company, along with its affiliates, granted Pfizer Inc. exclusive rights for the development, production, and commercialization of a dual-targeting antibody product (Project 707) outside of mainland China [2] - The revenue sharing from this licensing agreement is set at 30% for Sanofi Guojian and 70% for Shenyang Sanofi, based on prior R&D investments and asset ownership [2] - The agreement requires approval from the company's shareholders and antitrust regulatory bodies in the U.S. and other jurisdictions, introducing uncertainty regarding its effectiveness [2] Group 3 - The development, registration, and sale of the licensed product in the designated regions are subject to regulatory approvals, which are inherently uncertain due to the lengthy nature of new drug development [3] - Milestone payments tied to clinical and regulatory events are contingent upon the successful completion of specified conditions, adding another layer of uncertainty [3] - Sales milestone payments and royalties are dependent on market factors such as demand, competition, and sales channels, which may affect the actual revenue received by the licensing parties [3]

Core Viewpoint - Sangfor Biopharma (三生国健) has announced a collaboration with Pfizer for the development of project 707, a bispecific antibody targeting both PD-1 and VEGF, with potential uncertainties regarding milestone payments and royalties based on sales performance [1] Group 1 - Sangfor Biopharma's stock has experienced significant volatility, with a cumulative price deviation exceeding 30% over two trading days and 100% over four trading days, indicating abnormal trading activity [1] - The collaboration grants Pfizer exclusive rights to develop, produce, and commercialize the 707 project in regions outside mainland China for both human and veterinary applications [1] - The payment of milestone payments and royalties is contingent upon achieving specified sales targets, introducing uncertainty regarding the actual amounts received by the licensing parties [1] Group 2 - The sales performance of the licensed product may be influenced by various factors, including drug demand, market competition, and sales channels, contributing to the uncertainty surrounding the financial outcomes of the collaboration [1]

Core Insights - On May 20, 2023, 3SBio announced a significant agreement with Pfizer, granting exclusive global rights (excluding mainland China) for the development, production, and commercialization of its innovative PD-1/VEGF bispecific antibody SSGJ-707 [2] - The deal includes an upfront payment of $1.25 billion, setting a record for upfront payments for domestic innovative drugs, and potential milestone payments totaling up to $4.8 billion, bringing the total potential deal value to $6.05 billion (approximately 43 billion RMB) [2] - Following the announcement, 3SBio's stock surged over 35% on May 20 and continued to rise by over 8% the next day [2] Company Developments - SSGJ-707 has shown excellent efficacy in treating non-small cell lung cancer (NSCLC), with promising objective response rates (ORR) and disease control rates (DCR) in clinical trials [3] - The drug has received breakthrough therapy designation from the National Medical Products Administration (NMPA) for first-line treatment of PD-L1 positive locally advanced or metastatic NSCLC, and has also received IND approval from the FDA [3] - Clinical research for SSGJ-707 is also advancing in the treatment of colorectal cancer and gynecological tumors [3] Market Reactions - The capital market reacted strongly to the announcement, with 3SBio's stock price increasing significantly [2] - Other companies in the PD-1/VEGF bispecific antibody space, such as Kangfang Biologics, experienced stock fluctuations following the news, indicating a competitive landscape [5] Strategic Considerations - Pfizer's interest in the PD-1/VEGF bispecific antibody space is part of a broader strategy, as it has previously engaged in collaborations in this area [4] - The oncology segment of Pfizer is facing challenges with its small molecule drugs, prompting a shift towards ADC (antibody-drug conjugate) strategies, which are becoming a research focus [6] - The combination of ADCs with high-quality bispecific antibodies is seen as a potential avenue for enhancing treatment efficacy in oncology [6]

Core Viewpoint - The collaboration between Sanofi and Pfizer for the dual-specific antibody SSGJ-707 marks a significant step in the global commercialization of innovative cancer therapies, enhancing the international recognition and accessibility of Sanofi's products [1][2]. Company Summary - Sanofi and its affiliates granted Pfizer exclusive global rights (excluding mainland China) for the development, production, and commercialization of the dual-specific antibody SSGJ-707, with Pfizer retaining rights for commercialization in mainland China through additional payments [1]. - Pfizer will pay an upfront non-refundable fee of $1.25 billion, with potential milestone payments reaching up to $4.8 billion based on development, regulatory approval, and sales, along with a double-digit percentage sales share based on product sales in authorized regions [1]. - The antibody SSGJ-707 targets PD-1 and VEGF, having received breakthrough therapy designation from the National Medical Products Administration for treating advanced non-small cell lung cancer (NSCLC) [1][2]. Industry Summary - The collaboration signifies recognition of Sanofi's dual-specific antibody research platform by a leading international company, which is expected to enhance the global reach and acceptance of its products [2]. - The SSGJ-707 is currently in Phase III clinical trials for NSCLC and Phase II for other indications, indicating a robust pipeline for Sanofi's innovative therapies [2]. - The trend of Chinese innovative drug companies entering into licensing agreements with multinational pharmaceutical companies is growing, driven by the increasing recognition of Chinese innovation and the need for multinational firms to address patent cliffs [3][4].

证券代码： 688336 证券简称：三生国健 公告编号：2025-021 三生国健药业（上海）股份有限公司 关于与关联方共同签署许可协议暨关联交易的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 重要内容提示: ? 交易内容：三生国健药业（上海）股份有限公司（以下简称"本 公司"或"公司"或"三生国健"）及本公司的关联方三生制药和沈 阳三生制药有限责任公司（以下简称"沈阳三生"）共同授予被许可 方辉瑞公司（Pfizer Inc.）（以下简称"辉瑞"）在许可区域（即 除中国大陆以外的其他国家和地区）及领域（即人类和兽医用途的所 有治疗、诊断及预防适应症）的独家开发、生产和商业化许可产品 此外，被许可方保留通过支付额外的付款获得在中国大陆商业化许可 产品的权利。对于被许可方支付给许可方的所有款项将在遵守排他性 许可协议约定的前提下，按照各许可方对许可产品的前期研发投入、 截至《许可协议》签署日各方拥有的有关许可产品的资产权属等合理 因素于各方之间合理分配，具体分配比例为：三生国健 30%，沈阳三 生 70%。 ? 本交易 ...

Core Viewpoint - The biotech sector, particularly companies involved in monoclonal antibody cancer therapies, experienced significant stock price volatility due to competitive developments, particularly the FDA approval of Akeso's cancer drug [1][2]. Group 1: Company Developments - Summit Therapeutics saw its shares drop by 36.1% following the news of Akeso's FDA approval, despite having positive phase 3 trial data for ivonescimab [1][5]. - BioNTech's shares fell by 15.4%, likely influenced by the competitive landscape as Akeso's drug received approval while BioNTech's drugs remain in late-stage trials [1][7]. - Akeso's penpulimab-kcqx received FDA approval for treating nasopharyngeal carcinoma, and ivonescimab was approved in China for PD-L1-positive non-small cell lung cancer [3][4]. Group 2: Competitive Landscape - Akeso's approval of its cancer drugs has created a competitive challenge for Summit, especially since Akeso holds rights to ivonescimab in China [4][5]. - The approval of Akeso's drugs may allow it to explore additional cancer treatments, potentially impacting Summit's market position [6]. - The rapid developments in the bispecific antibody space highlight the intense competition and uncertainty in the biotech industry, affecting investor sentiment towards companies like Summit and BioNTech [8].