HK inno.N Corp.

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。 自2018年港交所推出《上市规则》第18A章，允许未盈利生物科技公司上市以来，该板块已成为中国创新药行业发展的关键“风向标”和“资金池”。 2025年，港股市场再次迎来一批生物科技公司集中提交上市申请。与数年前相比，本轮拟IPO的企业呈现出更鲜明的特点，研发管线多已进入中后期，部分产品临近或已实现商业化。部分企业通过对外授权实现价值获得国际认可，相比而言，企业的技术路径也更多元，涵盖了小核酸、AI制药、溶瘤病毒等前沿领域。 据不完全统计2025年港股递交IPO申请书的生物医药企业大约30家。本文将重点分析其中五家特色公司——真实生物、先为达生物、靖因药业、滨会生物与英矽智能在资本市场的未来发展方向。 从“拟IPO”到“已上市”的全景扫描 从整理的近30家企业来看，当前的港股生物科技板块正呈现清晰的梯队化趋势，部分企业已率先叩开资本市场大门，而更多公司则带着差异化的故事排队等候。 截至当前，今年已有三家生物医药公司成功在港交所上市，明慧医药凭借其“ADC产品矩阵+早期BD授权” 的模式获得认可，在上市前便将核心资产B7H3 ADC授权给齐鲁制药。 科望医药作为一家聚焦肿瘤免疫、拥有自主双抗平台（BiME）的公司，其与安斯泰来的早期平台合作，彰显了技术平台的价值获得国际认可。 宝济医药的其经历颇具戏剧性，从与Organon的授权合作到终止，再到与安科生物订立独家销售代理协议，表明其在商业化道路上的灵活的调整能力。  上表：据公开资料整理，不完全统计 综合来看，无论是已上市的“先行者”，还是正在排队的“后续梯队”，都试图通过聚焦某个资深领域、重磅BD或押注下一代平台等方式来构建独特的投资故事。 5大领域代表企业 洞察创新药未来最具代表性的方向与挑战，需深入各领域的代表性企业，分别是已凭借商业化产品穿越周期的真实生物、在全球化BD中创下纪录的先为达生物、押注下一代平台技术的靖因药业与滨会生物，以及作为AI制药标杆面临验证的英矽智能。 01 真实生物： 2025年11月，真实生物三战港股IPO，本次IPO核心或许是在“后疫情时代”如何重构抗病毒公司的价值逻辑，能否讲出一个超越阿兹夫定的新故事。 其专注于病毒感染、肿瘤、心脑血管疾病，核心管线阿兹夫定已经获批上市，用于治疗艾滋病毒感染、新冠病毒感染，同时在探索肿瘤适应症，后续管线还有CL-197、EGFR抑制剂、TOPO1抑制剂等。 图：真实生物 在研管线 02 先为达生物： 先为达生物于今年9月正式向港交所递交IPO申请，公司专注于开发针对肥胖及相关代谢疾病的创新疗法。其核心产品埃诺格鲁肽（XW003） 是全球首款“偏向型”GLP-1受体激动剂，已在国内提交上市申请。后续管线还包括该产品的口服周制剂、小分子GLP-1激动剂及Amylin类似物等，布局全面。 公司的国际化能力尤为突出，已成功完成两项重磅海外授权： * 2024年，将埃诺格鲁肽在韩国的权益授权给HK Inno.N，获近6000万美元首付款及里程碑款。 * 2025年1月，与英国Verdiva Bio达成协议，将口服埃诺格鲁肽（XW004）等产品在大中华区及韩国以外的全球权益进行授权，潜在交易总额超过24亿美元，创下中国代谢领域海外授权金额的最高纪录。 这两笔交易不仅为公司带来了可观的现金流，也强有力地印证了其产品的全球竞争力与商业价值。 图：先为达生物 在研管线 03 靖因药业： 靖因药业专注于开发小核酸（siRNA）疗法，其管线精准布局于心血管代谢这一广阔市场，核心产品针对FXI、Lp(a)及INHBE等前沿靶点。 公司的关键亮点在于其独特的“平台价值兑现”模式。2025年5月FXI siRNA与CRISPR Therapeutics采取50:50的全球共同开发模式，获得2500万美元现金和7000万美元股权，以及8亿美元里程碑金额，这种深度绑定的合作模式，远超普通授权。 靖因药业代表了从“产品开发”向“平台赋能”的进阶。其价值不仅在于单个管线，更在于已验证的siRNA发现与开发能力。  图： 靖因药业 在研管线 04 滨会生物： 滨会生物是一家拥有超过20年研发积淀的溶瘤病毒疗法公司，其核心定位是开发基于单纯疱疹病毒（HSV）的创新肿瘤免疫疗法。 首发管线BS001 (OH2) 已进入III期临床，有望成为全球首款基于HSV-2的溶瘤病毒疗法。与常见溶瘤病毒载体不同，其HSV平台具有诱导系统性抗肿瘤免疫反应的潜力。同时，公司已建立核酸药物平台，开发基于LNP递送的免疫调节产品（如BS003），展现了从“病毒载体”向“更广义的基因疗法”平台拓展的战略视野。 III期临床数据将直接决定其核心产品的价值兑现。同时，其“溶瘤病毒+核酸”的双平台故事能否获得市场认可，将检验市场对下一代基因治疗平台长期价值的评估逻辑。  图：滨会生物 在研管线 05 英矽智能： 英矽智能是一家AI驱动的药物研发公司，经过十年发展，已成为该领域的全球标杆。其核心价值并非单一管线，而在于已验证的端到端AI药物发现平台。 首发管线TNIK抑制剂（用于特发性肺纤维化）是全球首批由AI发现并进入临床阶段的分子之一，近期被国家药监局纳入突破性治疗药物程序，标志着其临床潜力获得官方认可。在推进首款产品的同时，后续管线（如USP1、KAT6等抑制剂）持续产出。 英矽智能的IPO将是市场对“AI制药”这一新方式的关键检验。能否证明AI不仅能缩短研发时间，更能发现具有显著临床优势的分子或将是其下一个课题。  图：英矽智能 在研管线 2025年港股生物科技板块迎来新一轮上市窗口，各家企业的策略与路径已更加清晰。所有申请IPO的生物医药企业共同指向一个明确的趋势，行业正逐步摆脱同质化竞争，进入以差异化创新与实质性进展为核心竞争力的新发展阶段。 我们期待，国内生物医药企业不仅能成功登陆资本市场，更能以此为契机，持续聚焦真正的临床价值，在核心技术领域实现从跟跑到并跑的跨越。 参考资料：各企业官网、公开资料 END 官方建群啦！ 生物药大时代组建了抗体药、疫苗、核酸药物等多个相关领域的实名制微信交流群，扫描下方二维码即可入群！

HK inno.N Acquires Japanese Business Rights for K-CAB and Equity Stake in RaQualia - HK inno.N acquires Japanese business rights for K-CAB from RaQualia, a Japanese drug discovery firm. - The company secures global business rights for K-CAB in top markets, including Japan (the world’s 3rd largest), following successful entries into China and the U.S. - HK inno.N acquires additional newly issued shares in RaQualia, increasing its total equity stake to 15.95% and accelerating new drug development. Photo. Left: HK inno.N BI _ Right: RaQualia CI HK inno.N announced on December 15th that it signed an agreement to acquire the Japanese business rights for K-CAB (active ingredient: tegoprazan), a novel treatment for gastroesophageal reflux disease (GERD), from RaQualia Pharma Inc., a Japanese drug discovery firm. The agreement also includes the acquisition of additional newly issued shares of RaQualia through a third-party allotment paid-in capital increase. Through this agreement, HK inno.N secures the development, manufacturing, and sales rights for K-CAB in the Japanese market. Additionally, by acquiring 1,555,900 shares of RaQualia, the company increased its equity stake by 5.98%.. This marks the second acquisition following the first acquisition of newly issued shares in March this year, and HK inno.N now holds a total of 15.95% stake as the largest shareholder of RaQualia. RaQualia, founded in 2008 by former researchers from Pfizer Japan, licensed the K-CAB compound, a novel treatment for gastroesophageal reflux disease (GERD), to HK inno.N in 2010. . The company currently holds a diversified pipeline for 18 drug candidates, spanning therapeutic areas such as gastrointestinal disorders, pain, and oncology. With this agreement, HK inno.N has successfully secured the business rights for K-CAB in the world’s first,t second, and third largest pharmaceutical markets—the U.S., China, and Japan—further raising expectations for its global growth. The peptic ulcer medications market in Japan is worth approximately KRW 2 trillion (USD 1,227 million), making it the world's third-largest market. While K-CAB is not currently marketed in Japan, this agreement paves the way for its market entry. “This agreement will enhance our innovative new drug portfolio by combining the R&D capabilities of both companies, further boosting the global market competitiveness of K-CAB,” said Dalwon Kwak, CEO of HK inno.N.. “Through our strategic partnership with RaQualia, we will conduct joint research on additional new drug pipelines, thus solidifying our standing in the global pharmaceutical market,” he added. K-CAB, a novel agent for GERD treatment, is the 30th new drug of South Korea developed by HK inno.N. Following its first launch in South Korea in March 2019, K-CAB recorded the cumulative outpatient prescription sales amounting to KRW 902.2 billion up to November this year. The drug has been licensed or distributed to 54 countries, including China and the U.S. (the figure includes South Korea), and has been officially launched in 18 countries to date. (The end) (Reference Information) Size of the peptic ulcer medications market in Japan: USD 1,227 million (based on the exchange rate 1,460 won/dollar) (source: IQVIA 2024 MAT)

HK inno.N and Kine Sciences to Jointly Develop Sarcopenia Treatment and Initiate Phase 2 Clinical Trial Joint development of Sarcopenia drug candidate ‘KINE-101’ and accelerated plans for phase 2 clinical trial in Korea Expansion of ‘KINE-101’ indications to Sarcopenia, following Rheumatoid Arthritis and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Anticipated synergy with HK inno.N’s obesity treatment currently under development Photo. HK inno.N CEO Darl-Won Kwak (front row, right) and Kine Sciences CEO Dae-Ho Cho (front row, left), along with researchers from both companies, are taking a commemorative photo to mark the signing of the joint R&D agreement. HK inno.N is actively advancing the development of a Sarcopenia treatment, accelerating the expansion of its portfolio in aging-related and metabolic diseases. On November 18, HK inno.N announced that it had recently signed a joint research and development agreement with Kine Sciences for ‘KINE-101,’ an inflammation-modulating peptide-based drug candidate for the treatment of Sarcopenia. Under the agreement, HK inno.N will lead the phase 2 clinical trial in Korea for KINE-101, while Kine Sciences will handle the manufacturing of the investigational medicinal product and provide technical support. Both companies will collaborate closely to ensure a swift initiation of the clinical program and secure commercialization potential in Korea, with the goal of entering phase 2 next year. ‘KINE-101’ is a peptide derived from ERDR1 (Erythroid Differentiation Regulator 1), a key protein involved in regulating inflammatory responses. It is an innovative drug candidate with mechanisms that maintain immune homeostasis and alleviate inflammation. The compound has completed a phase 1 clinical trial in the United States as a treatment for rheumatoid arthritis and a clinical study in Korea for chronic inflammatory demyelinating polyneuropathy (CIDP). It has also successfully completed preclinical studies for the Sarcopenia indication. Sarcopenia is caused by various factors such as aging, obesity, and metabolic disorders, and the number of patients is rapidly increasing as global population aging accelerates. Among Koreans aged 65 years and older, the prevalence of Sarcopenia is approximately 9.5% in men and 9.3% in women, and the demand for related treatments continues to grow. Under this joint development agreement, synergy in reducing muscle loss through combination use with ‘IN-B0009,’ HK inno.N’s obesity treatment currently in a domestic phase 3 clinical trial, is also anticipated. Most obesity treatments currently approved or under development have the limitation of causing muscle loss alongside weight reduction. KINE-101 is therefore considered to have differentiated value as a muscle-preserving therapy. Dalwon Kwak, CEO of HK inno.N, stated, “In preparation for an aging society, we are continuously strengthening our portfolio of treatments for chronic diseases. We are fully committed to developing a Sarcopenia therapy in collaboration with Kine Sciences, aiming not only to secure leadership in the Korean market but also to actively pursue global technology out-licensing.” Dae Ho Cho, CEO of Kine Sciences, stated, “KINE-101 is an innovative peptide drug candidate that restores immune homeostasis by activating regulatory T cells (Tregs). It has demonstrated therapeutic potential across various immune and inflammatory diseases. Through this collaboration, we expect to successfully advance the development of a Sarcopenia treatment for older adults.” (END) (Reference Information) CIDP: chronic inflammatory demyelinating polyneuropathy Source of Sarcopenia prevalence in Korea: Press release “Results of the 2024 Korea National Health and Nutrition Examination Survey – Increase in Chronic Disease Prevalence, Improvement in Treatment Rates,” Korea Disease Control and Prevention Agency (KDCA), September 30, 2025.