理论上可通过追求更高浓度和更低注射体积，使抗衰除皱效果维持更久。 文 ｜ 胡香赟 编辑 ｜ 海若镜 近年来，不少国内外医药公司都在探索创新的A型肉毒素生产技术。通过将A型肉毒素的基因序列克隆在大肠杆菌等工程菌中，发 酵产生肉毒素前体蛋白，激活后获得重组A型肉毒素，理论上重组产品在安全性、可靠性和产品纯度方面都更具优势，也符合生 物制剂产品从提取技术转向重组技术的大趋势。 "我们合作方的技术已通过大肠杆菌表达出稳定、高纯度且具有高度活性的肉毒素核心蛋白。第一代产品已完成III期临床，展现 出安全性和免疫原性，验证了其技术的可行性。本次交易中，我们获得的003是进一步迭代的产品，从传统的冻干制剂升级为液 体预充制剂，拆开包装即可使用。"纽尔利资本医疗组负责人表示。 该负责人进一步介绍，当前，艾尔建、高德美等国际药企也探索过相关液体剂型的专利和产品布局。除了使用更便捷、更精准、 避免人为操作带来了的使用误差之外，这种剂型还在浓度等方面进一步探索产品优势。"稳定可靠的液体制剂可以通过追求更高浓 度和更低注射体积，有望使精准的抗衰除皱效果维持更久。" 封面来源 ｜ Pexels 36氪获悉，Revelyx Bio In ...

文｜胡香赟 编辑｜海若镜 36氪获悉，Revelyx Bio Inc.（下称"Revelyx"）近期已完成数千万美元A轮融资。本轮融资由纽尔利资本 （NRL Capital）独家领投，募集资金将用于推进公司旗下产品在全球范围内的临床研发和商业拓展。 Revelyx于2025年在美国特拉华州设立，是由纽尔利资本等3家国际投资机构联合孵化的NewCo企业，核 心管线重组A型肉毒毒素液体制剂003来自于一家中国创新药企，现已在澳洲开展眉间纹适应症的临床II 期试验。按照协议，Revelyx拥有003在除中国大陆、香港特别行政区、澳门特别行政区外的海外市场独 家许可权益。 "我们合作方的技术已通过大肠杆菌表达出稳定、高纯度且具有高度活性的肉毒素核心蛋白。第一代产 品已完成III期临床，展现出安全性和免疫原性，验证了其技术的可行性。本次交易中，我们获得的003 是进一步迭代的产品，从传统的冻干制剂升级为液体预充制剂，拆开包装即可使用。"纽尔利资本医疗 组负责人表示。 该负责人进一步介绍，当前，艾尔建、高德美等国际药企也探索过相关液体剂型的专利和产品布局。除 了使用更便捷、更精准、避免人为操作带来了的使用误差之外，这种剂 ...

记者丨季媛媛 韩利明 编辑丨张伟贤 BD（商务拓展），曾在生物医药领域融资市场持续收紧的"资本寒冬"中，为中国生物科技公司（Biotech）带来了新的募资契机。 2025年，BD掀起了前所未有的热潮。央视财经数据显示，截至2025年11月18日，国产创新药对外授权总金额已突破千亿美元，相较于2024年 实现了翻倍式增长。手握优质BD项目的Biotech迎来了股价上涨、IPO畅通等红利，更有不少企业提前预告BD进展。 BD交易的持续强劲，既印证了中国医药资产在全球范围内性价比与竞争力的提高，推动行业迈入"创新兑现+全球布局"的关键时期，也引发了 行业对交易质量的深入审视。一方面，"本土创新低卖"等争议随着交易数量的增加而同步升温；另一方面，业内普遍认为，BD交易的考验不 在于签单的金额和数量，而在于协议签署后产品价值落地的实现。 事实也是如此。BD交易对于创新药全球价值的实现固然重要，但BD交易后，产品本身全球价值的逐步验证和实现更为关键。而产品全球价值 的验证和实现主要影响因素包括全球临床的推进、产品数据的发布、竞争格局的变化等。 未来行业BD走向究竟怎样？对此，高特佳投资副总经理于建林向21世纪经济报道记者 ...

Core Viewpoint - The article highlights the unprecedented surge in business development (BD) activities in China's biotech sector, with the total amount of domestic innovative drug licensing exceeding $100 billion by November 18, 2025, marking a doubling compared to 2024. This trend reflects the increasing global competitiveness and value of Chinese pharmaceutical assets, while also prompting a deeper examination of transaction quality and product value realization post-agreement [1][2]. Summary by Sections BD Market Dynamics - The BD market in China is experiencing a significant boom, with a projected compound annual growth rate (CAGR) for external BD activities expected to remain in double digits over the next five years, despite a forecasted decline in growth rate [2]. - Key characteristics of future transactions include an increase in late-stage pipeline contributions and a shift from pure technology transfer to models involving "licensing + co-development + commercialization" [2]. Major Transactions - Notable transactions in 2025 include: - Hengrui Medicine's collaboration with GSK, involving a total potential amount of approximately $120 billion, with an upfront payment of $500 million [3]. - Innovent Biologics' agreement with Takeda, with a potential total of $114 billion and an upfront payment of $1.2 billion [3]. - A record-setting deal between 3SBio and Pfizer, with an upfront payment of $12.5 billion and potential milestone payments reaching $48 billion [5][6]. Global Interest in Chinese Biotech - Chinese innovative drugs are gaining significant traction in global markets, with multinational corporations increasingly sourcing early-stage innovation pipelines from China due to cost-effectiveness and potential efficacy [7][8]. - The trend indicates a shift where Chinese biotech firms are evolving from technology providers to value co-creators in the global pharmaceutical landscape [7]. Transaction Models - The dominant transaction model remains "License-out," which accounted for 91% of upfront payments and 99% of total amounts in related transactions in the first half of the year [10]. - NewCo models are gaining popularity, allowing companies to inject parts of their product pipelines into newly formed entities with foreign capital, reflecting a flexible asset operation strategy [10][11]. Future Outlook - The BD market is expected to continue thriving, driven by the need for multinational companies to replenish their pipelines as many blockbuster drugs face patent expirations, creating a significant market opportunity [15]. - Emerging technologies, particularly in ADCs and bispecific antibodies, are anticipated to dominate future BD transactions, with a notable interest in metabolic and autoimmune products [16][17]. Challenges and Considerations - Despite the growth, challenges remain in ensuring compliance with international standards and protecting intellectual property during global collaborations [13]. - The market is expected to stabilize, with a rational return to expectations regarding BD transactions, as the industry matures and the focus shifts from explosive growth to sustainable value creation [17].

Core Insights - The surge in BD (business development) transactions in China's innovative pharmaceutical sector is a reflection of the industry's maturation and increasing global recognition, with 2025 marking a significant year for License-out agreements [3][4][5] Group 1: BD Transactions Overview - In December 2025, several Chinese pharmaceutical companies, including Ganli Pharmaceutical and Heng Rui Medicine, announced significant BD agreements, indicating a trend towards increased collaboration and innovation in the sector [2] - The total value of BD transactions for Chinese innovative drugs reached $135.655 billion in 2025, with upfront payments totaling $7 billion, marking a historical high in both transaction volume and value [3] - The number of BD transactions involving Chinese companies and top multinational corporations (MNCs) increased from 3 in 2015 to 35 in 2025, highlighting the growing interest from global players [3] Group 2: Market Dynamics and Future Outlook - The BD transaction boom is expected to continue into 2026, with industry experts predicting sustained high activity levels, although the focus may shift from quantity to value [5][14] - The NewCo model, which allows for "technology equity + capital cooperation," is emerging as a new pathway for Chinese pharmaceutical companies to engage in international markets, although its prevalence may decrease in 2026 [14][15] - The overall trend indicates a shift from isolated transactions to a more collaborative ecosystem, where companies leverage partnerships to enhance their global market presence [16][20] Group 3: Transaction Structures and Strategies - The structure of BD transactions is evolving, with companies increasingly engaging in co-development and co-commercialization agreements, allowing for shared risks and benefits [10][11] - The pricing of BD transactions is becoming more rational, with companies focusing on the clinical value and market potential of their products, which influences upfront payment amounts [19][18] - Legal and advisory services are becoming integral to BD transactions, reflecting the increasing complexity and importance of these deals in the pharmaceutical landscape [17]

整理 | GLP1减重宝典内容团队 一条极具诱惑力、也极其艰难的技术路线 ORMD-0801 最大的亮点，在于它试图解决一个全球医学界长期未解的难题：让胰岛素实现真正的口服给药。相较注射制剂，口服形式 在患者依从性、长期用药体验上具有天然优势。 从需求端看，全球糖尿病患者规模庞大，胰岛素市场本身就具有足够吸引力。更关键的是，在口服降糖药中，绝大多数药物依赖患者自 身残存的胰岛β细胞功能来促进胰岛素分泌。对于病程较长、胰岛功能几乎耗竭的2型糖尿病患者而言，外源性胰岛素几乎是唯一选择。 但长期注射所带来的依从性问题、安全性隐患，也正是口服胰岛素被寄予厚望的根本原因。这一逻辑，并非天汇生物独有，而是整个行 业的共同判断。 12月29日，国家药监局官网一则并不起眼的通知，引发了业内对口服胰岛素命运的再度关注。合肥天汇生物申报的重组人胰岛素肠溶胶 囊 ORMD-0801 出现在当日药品通知件送达信息中，意味着这款备受期待的创新药未能获得批准。 次日，天汇生物方面回应称，此次注册申请终止为公司主动撤回，是整体战略调整的一部分。但在医药产业看来，这一结果并非单一企 业的取舍，而是再次凸显了口服胰岛素这一"高难度赛道"的长期 ...

Core Viewpoint - The TCE bispecific antibody sector is entering a "golden era" with significant growth potential and innovation opportunities in cancer and autoimmune disease treatments [2][9]. Company Overview - A new generation of bispecific antibody pioneer, "Anmai Biotech," is advancing its listing process on the Hong Kong Stock Exchange, with a focus on T cell engagers (TCE) to address unmet medical needs in cancer and autoimmune diseases [3][4]. - Anmai Biotech has developed a robust pipeline of products, including three clinical-stage candidates: core product EMB-01, key product EMB-06, and EMB-07, along with four preclinical TCE candidates [4]. Commercialization Strategy - Anmai Biotech demonstrates industry-leading commercialization capabilities and is a model for domestic innovative drug companies expanding internationally through the NewCo model, having secured over $2.1 billion in global licensing deals, ranking second in the TCE field [6][8]. - The NewCo model allows for higher upfront payments and better resource integration, enabling partnerships with top global players to maximize the value of innovative assets [6]. Key Collaborations - A notable collaboration involves EMB-06, with a potential total transaction value of $635 million, showcasing the company's strategic partnerships and rapid clinical development efforts [7]. - Anmai Biotech has also engaged in multiple high-value business development transactions, including a global licensing agreement with Juri Biosciences worth up to $210 million [8]. Market Outlook - The global TCE market is projected to grow from $400 million in 2020 to $3 billion in 2024, with an expected CAGR of 43.4% from 2024 to 2034, indicating a significant market opportunity for Anmai Biotech [9].

Core Viewpoint - The article emphasizes that investing in the innovative drug sector in Hong Kong is one of the most promising opportunities for 2025, with significant growth potential compared to other sectors, particularly in light of the recent performance of the Hang Seng Index and the healthcare indices [3][5]. Group 1: Market Performance - The Hang Seng Index has achieved a return of over 28% this year, ranking among the top global markets, but the innovative drug sector has outperformed with an 80% increase in indices related to innovative drugs [3][5]. - The innovative drug sector's performance is attributed to a combination of fundamental, emotional, valuation, and monetary factors, creating a synergistic effect that has driven growth [6]. Group 2: Financial Metrics - In the first half of 2025, the total revenue for 36 companies in the Hong Kong innovative drug sector is projected to be 28.5 billion RMB, reflecting a year-on-year growth of 15.8%, with a net profit of 1.8 billion RMB [6][7]. - Expanding the sample to 50 Hong Kong "18A companies," total revenue reached 44.9 billion RMB, with a year-on-year growth rate of 31.48% and a net profit of 2.727 billion RMB, showing a significant increase of 128.4% [7]. - For a broader sample of 149 Hong Kong pharmaceutical companies, total revenue was 896.12 billion RMB, with a modest growth of 1%, while net profit increased by 29.7% [7]. Group 3: Industry Trends - The innovative drug industry is seen as a natural fit for large countries like China, which can leverage its industrial chain advantages to reduce high R&D costs, making it more feasible to develop new drugs compared to markets like the U.S. [12]. - The article discusses the evolution of the innovative drug sector, highlighting the transition from generic drugs to innovative products, and the increasing clarity in the industry's development trajectory [10][12]. Group 4: Business Development Models - Business Development (BD) and NewCo models are crucial in the innovative drug sector, with BD involving licensing agreements that allow companies to recoup investments quickly while minimizing commercialization risks [14][15]. - The NewCo model allows companies to establish new entities for overseas operations, facilitating funding and development while retaining stakes in the original company [15][16]. - The BD model is not yet saturated, as many multinational corporations face patent cliffs and are actively seeking to replenish their pipelines through licensing agreements [16]. Group 5: Market Environment - The innovative drug sector is heavily influenced by monetary conditions, with low interest rates fostering a favorable financing environment, which is essential for companies that rely on external funding and M&A activities [17][18]. - The article notes that the healthcare sector in Hong Kong has raised a total of 61.5 billion HKD in funding as of August 31, 2025, indicating a robust fundraising environment that surpasses the total of the previous three years [18].

Core Insights - The article discusses the significant achievements and ongoing questions surrounding China's innovative pharmaceuticals, highlighting a pivotal moment akin to the "Sputnik moment" for the U.S. in the 1950s, where China has surpassed the U.S. in overseas licensing deals for innovative drugs, reaching $51.9 billion in 2024 [3][4][7]. Group 1: Market Dynamics - In 2023, the total amount of outbound business development (BD) transactions for Chinese innovative drugs was $8.4 billion, which surged to $51.9 billion in 2024, marking a 65% year-on-year increase [7][10]. - The first half of 2025 has already seen licensing deals nearing $66 billion, indicating a robust growth trajectory in the sector [7][10]. - The current BD activity reflects a long-term accumulation of industry capabilities, showcasing the effectiveness of the ecosystem from research to clinical application [8][9]. Group 2: Investment Sentiment - Investors express optimism about the sustainability of the current BD boom, with many believing that the ongoing trends will continue to benefit the sector [9][10]. - The anticipated U.S. interest rate cuts and the "patent cliff" faced by major pharmaceutical companies are expected to create favorable conditions for Chinese biotech firms to provide valuable pipelines [10][11]. - The disparity in upfront payments for BD transactions between China and the U.S. remains significant, with Chinese deals being 5-6 times lower, raising questions about the perceived value of these transactions [10][11]. Group 3: Challenges and Opportunities - Despite the positive outlook, there are concerns regarding the sustainability of the current BD activity and whether it can maintain momentum in the face of market fluctuations [4][10]. - The article highlights the importance of clinical data in securing BD deals, with many companies struggling to balance funding needs with the demands of clinical development [15][18]. - The emergence of the "NewCo" model, where investment firms acquire undervalued pipelines to further develop and sell, is seen as a potential avenue for mitigating risks and enhancing cash flow for innovative drug companies [21][22]. Group 4: Future Prospects - The establishment of supportive ecosystems, such as the "Beijing Drug and Medical Device Innovation Service Station," aims to enhance registration and approval efficiencies for innovative drug companies [8][9]. - The article concludes that China's innovative pharmaceuticals are now positioned on a global competitive stage, with the potential for significant advancements in addressing patient needs [23].

Core Insights - The article highlights the rise of 康诺亚 as a prominent player in the "BD为王" (BD is King) innovation drug market, having completed four NewCo transactions in the past year, establishing itself as a "NewCo factory" through asset splits and cross-border collaborations [1][3][4] - While the NewCo model is seen as a promising concept, it fundamentally relies on the potential of pipeline assets, creating uncertainty regarding the realization of expected outcomes [2][7] NewCo Empire - 康诺亚 has strategically executed four NewCo transactions, solidifying its position as a specialist in this model through precise asset selection and strong capital partnerships [3] - The transactions include: - July 2024: Partnership with OrbiMed's Belenos for TSLP×IL-13 dual antibody CM512, receiving $15 million upfront and potential milestone payments of up to $170 million [4][5] - November 2024: Exclusive licensing agreement with Platina Medicines Ltd for CM336, with an upfront payment of $135 million [4][5] - January 2025: Collaboration with Timberlyne for CD38 monoclonal antibody CM313, securing $30 million upfront and potential milestone payments of up to $337.5 million [6] - January 2025: Joint venture with Prolium for CD20/CD3 dual antibody CM355, receiving $8.75 million upfront and potential milestone payments of up to $502.5 million [6] - These transactions have created a "NewCo empire" for 康诺亚, allowing it to cover multiple therapeutic areas while enhancing cash flow through upfront and milestone payments [6][7] Clinical and Market Challenges - The pipeline assets involved in the NewCo model are primarily in early clinical stages, which introduces significant uncertainty regarding their future success [8][9] - The success rate for drugs from early clinical trials to market is less than 10%, with additional competition from established products in the same therapeutic areas [9][10] - The valuation of NewCo equity is based on future expectations rather than actual asset value, leading to potential discrepancies if market conditions worsen [10][11] Financial Performance and Market Dynamics - 康诺亚's cash reserves increased to approximately 2.796 billion yuan in the first half of 2025, up by 200 million yuan from the previous year, supported by NewCo transactions [6] - Despite strong expectations for its core product 康悦达, sales have not met projections, with only 1.69 billion yuan achieved in the first half of 2025, representing 33.8% of the annual target [13][14] - The competitive landscape for 康悦达 is challenging, with multiple candidates in clinical stages for similar indications, raising concerns about its market position [13][14] Conclusion on NewCo Model - The NewCo model provides short-term cash flow and pipeline expansion but carries inherent risks of over-leveraging future expectations, potentially leading to commercialization challenges [10][11][15] - The reliance on external investors for pipeline valuation and the loss of core control over potential blockbuster assets may weaken long-term competitiveness [11][15]