将投中网设为"星标⭐"，第一时间收获最新推送 此一时彼一时。美国当年综合实力领先苏联太多，再加上眼一闭心一横，反超苏联不难。但终归，美 国不再是当年的美国，中国也不是那时的苏联，拿创新药来说，中国走的可不是"大力出奇迹"的路 子，而是在原料药、研发外包乃至很多创新药管线，近乎全方位将美国"拿捏"得死死的。 信心普遍很足，疑问倒也不是没有，比如未来BD交易持续性到底如何？为什么同样消沉了好几年， 相比于因为利好不断而火热的二级市场，一级市场明显有种不对称的冷清？创新药创业公司情况有变 得更好吗？再比如，虽然绝对金额一直在飙升，但平均下来看，中国出海BD交易的首付款仍然不 高，走"性价比"路线也有争议，很多资产到底算不算"贱卖"？另外，就算是二级市场，大额BD也无 法刺激创新药表现了，这是为什么？最近引发不少讨论的NewCo又是怎么回事？ 总之，关于中国创新药的成绩和疑问，还是得坐下来当面聊聊。 关于中国创新药的成绩和疑问，还是得好好聊聊。 作者丨张楠 来源丨 投中网 不知道各位最近去没去过中关村鼎好。对，就是刘强东发迹的那个"电脑城"。 今年2月，鼎好后面加了个"DH3"，摇身一变成了海淀科创生态的集中地之一， ...

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]

Core Insights - The report by KPMG highlights the dynamic and growth-oriented nature of China's biotechnology sector, emphasizing the interplay of policy, technology, capital, and international collaboration in driving industry transformation [1][2] - The integration of artificial intelligence in the healthcare sector is creating unprecedented opportunities, enhancing research efficiency, product innovation, and supply chain optimization [1] - The report indicates that China's innovation-driven pharmaceutical sector is entering a golden development period, with a shift from cost competition to value creation in the CDMO space [1] Industry Trends - China's biotechnology industry is becoming increasingly significant in the global innovation landscape, focusing on emerging areas such as cell therapy, gene therapy, in vitro diagnostics, and AI-driven pharmaceuticals [2] - The globalization of Chinese biopharmaceuticals has transitioned from an optional strategy to a necessary one, with a notable increase in license-out transactions since 2020 [2] - The deep integration of scientific innovation and business models is identified as a key factor for success in the current biotechnology landscape [2]

Core Insights - Kailera Therapeutics raised $600 million in a Series B funding round led by Bain Capital, marking one of the largest private biotech deals of the year amidst a challenging U.S. biopharmaceutical market in 2025 [1][2] - The success of this funding is primarily attributed to the positive results from the Phase 3 clinical trials of KAI-9531, a GLP-1/GIP dual receptor agonist developed in collaboration with Chinese pharmaceutical giant, HengRui Medicine [2][4] Funding and Clinical Data - KAI-9531 demonstrated impressive results in a 48-week Phase 3 trial in China, with an average weight loss of 17.7% across all tested doses, and 88% of participants losing at least 5% of their body weight, while 44.4% lost over 20% [2] - The certainty of clinical data, rather than just the mechanism similarity to Eli Lilly's Zepbound, was a key factor in attracting top-tier investors like Bain Capital [2] Strategic Moves - Following the Phase 3 data release, Kailera quickly secured approval from the FDA to initiate global Phase 3 clinical trials, indicating a swift progression in their development timeline [2] - The $600 million funding will enable Kailera to expand its operations globally, particularly in the U.S. market, which is crucial for the pharmaceutical industry [3] HengRui's Global Strategy - HengRui's "NewCo" model allowed it to transfer global development, production, and commercialization rights of three GLP-1 drugs to a newly established U.S. company, Hercules, which was backed by Bain Capital and other investors [4][7] - The total deal value could reach $6 billion, including various milestone payments, while HengRui retains approximately 19.9% equity in Kailera [4] Benefits of the NewCo Model - This model allows HengRui to avoid the high costs associated with conducting global Phase 3 trials independently, while still benefiting from the potential commercial success of its drug pipeline [8] - By leveraging Kailera's experienced management team and strong investor backing, HengRui can expedite its global expansion and clinical progress [8] Broader Implications - The successful funding and development of KAI-9531 signify a growing trend of Chinese companies with strong R&D capabilities becoming key players in the global innovative drug market [9] - This trend reflects the increasing recognition of "China innovation, global realization" as a viable strategy in the biopharmaceutical landscape [9]

Core Viewpoint - The recent licensing agreement between Nuo Cheng Jian Hua and Zenas has led to a significant market reaction, with Nuo Cheng Jian Hua's stock dropping while Zenas's stock surged, indicating a divergence in market sentiment regarding the deal's value and potential [1][2]. Summary by Sections Licensing Agreement Details - Nuo Cheng Jian Hua has licensed its BTK inhibitor, Oubutini, for multiple sclerosis and other autoimmune diseases to Zenas, receiving an upfront payment of $100 million, milestone payments, and 7 million shares of Zenas stock, with a total potential deal value exceeding $2 billion [1][2]. - The upfront payment and stock value combined amount to $280 million, which is considered reasonable compared to industry standards, where the average upfront payment ratio is around 8% [3]. Market Reaction and Sentiment - The market's cautious sentiment towards the deal stems from two main concerns: the upfront payment not meeting expectations and the perceived lack of recognition of Zenas as a partner [2][5]. - Nuo Cheng Jian Hua's stock fell by 6.24% in A-shares and 11.64% in Hong Kong shares, while Zenas's stock rose by 24.22% following the announcement [1]. Strategic Considerations - Nuo Cheng Jian Hua had previously engaged with multinational corporations (MNCs) but ultimately chose Zenas due to smoother communication and Zenas's strong clinical development capabilities, particularly in the field of multiple sclerosis [5][10]. - Zenas, founded in 2019 and listed on NASDAQ in 2024, currently has no commercial products but has a promising pipeline, including a dual-function monoclonal antibody that complements Oubutini [7][8]. Industry Context - The collaboration reflects a shift in the global innovation drug landscape from one-time licensing deals to deeper collaborative models, where local pharmaceutical companies can retain equity in new ventures [12]. - Nuo Cheng Jian Hua's previous partnership with Biogen ended after about 18 months, highlighting the challenges in securing long-term collaborations in the industry [11]. Future Outlook - The partnership aims to advance the development of Oubutini in treating primary and secondary progressive multiple sclerosis, with significant market opportunities projected in the U.S. alone [8]. - The success of this collaboration will depend on Zenas's ability to progress its pipeline and the overall market performance of its shares [12].

Core Insights - The Chinese innovative pharmaceutical industry is at a historic juncture, with significant overseas licensing deals and challenges arising from potential U.S. regulatory scrutiny [2][3]. Group 1: Market Performance - In 2024, the Chinese innovative drug sector achieved 94 overseas licensing transactions totaling $51.9 billion [5]. - By mid-2025, the momentum continued with 72 transactions exceeding $60 billion, surpassing the previous year's total of $8.1 billion [6]. - The secondary market for biopharmaceuticals has shown signs of recovery, with companies like BeiGene reaching a market cap of over 500 billion yuan [7]. Group 2: Regulatory Challenges - The Trump administration is considering mandatory reviews by the Committee on Foreign Investment in the United States (CFIUS) for transactions involving U.S. pharmaceutical companies acquiring rights to Chinese drugs [8]. - If implemented, this could hinder the supply channels for Chinese experimental therapies to the U.S. market, impacting both U.S. and Chinese pharmaceutical companies [8]. Group 3: Financial Dynamics - Despite high transaction volumes, upfront payments for Chinese pharmaceutical deals remain significantly lower than those in the U.S., with only $2.9 billion in upfront payments out of $60.8 billion in total transactions [10]. - The disparity indicates a persistent reliance on "cost-performance" perceptions, leading to a notable valuation gap compared to international markets [10]. Group 4: Investment Trends - The domestic biopharmaceutical investment landscape is still in a downturn, with 371 financing events totaling approximately 20 billion yuan, reflecting a year-on-year decline of 31.2% [13]. - However, the industry is transitioning from a "burning cash" phase to demonstrating healthier self-sustaining capabilities, as evidenced by companies like BeiGene achieving profitability for the first time [16]. Group 5: Innovation and Collaboration - The integration of artificial intelligence in drug development is enhancing global competitiveness by reducing costs and shortening timelines [17]. - The NewCo model, which involves local investment institutions leading new company formations, is gaining traction, providing a flexible exit mechanism for early-stage innovations [21][20].

Core Viewpoint - Heng Rui Medicine has announced a new collaboration with Braveheart Bio for the global development and commercialization of its heart disease drug HRS-1893, marking its second NewCo transaction aimed at expanding its international presence [1][3]. Group 1: Transaction Details - Heng Rui Medicine will receive a total of $65 million in upfront payments, consisting of $32.5 million in cash and $32.5 million in equity from Braveheart Bio [1]. - After the technology transfer, Heng Rui will receive an additional $10 million milestone payment, along with potential milestone payments and sales royalties that could total up to $1.013 billion, bringing the maximum potential revenue from this deal to $1.088 billion [1]. - A joint management committee will be established to coordinate the global development and commercialization of the licensed product, with equal representation from both companies [1]. Group 2: Product Development Status - HRS-1893 is currently undergoing a Phase III clinical trial in China for obstructive hypertrophic cardiomyopathy, which is a common hereditary heart disease and a leading cause of sudden cardiac death among adolescents and athletes [2]. Group 3: Previous Transactions and Company Background - This is Heng Rui Medicine's second NewCo model transaction; the first involved licensing three GLP-1 innovative drugs to a newly established U.S. company, Kailera, for an upfront payment of $100 million and a potential total deal value of $6 billion [3]. - Braveheart Bio was established in 2024 in Delaware, USA, with major investors including Forbion Capital and OrbiMed, and is led by CEO Travis Murdoch, who has a history of successful clinical project management [3][4]. - As of September 5, Heng Rui Medicine's A-shares rose by 3.35%, with a market capitalization of 470.9 billion yuan, while its Hong Kong shares increased by 3.07%, with a market capitalization of 555.9 billion HKD [4].

Core Insights - HengRui Pharma has entered into an exclusive licensing agreement with Braveheart Bio for its proprietary Myosin small molecule inhibitor HRS-1893, aimed at treating Hypertrophic Cardiomyopathy (HCM) [1][2] - The agreement grants Braveheart Bio exclusive rights to develop, manufacture, and commercialize HRS-1893 globally, excluding Greater China, with an upfront payment of $65 million and potential milestone payments totaling up to $1.013 billion [1][2] - HRS-1893 is a significant innovation in HengRui's cardiovascular portfolio, currently in Phase III clinical trials, with over 10 innovative products in clinical research stages targeting cardiovascular diseases [3] Financial Terms - Braveheart Bio will pay HengRui a total of $75 million, which includes $32.5 million in cash and $32.5 million in equity, along with a $10 million milestone payment upon successful technology transfer [1] - The potential milestone payments related to clinical development and sales could reach up to $1.013 billion, in addition to sales royalties [1] Market Potential - The CEO of Braveheart Bio expressed confidence in HRS-1893's potential as a best-in-class Myosin inhibitor, highlighting the significant unmet needs in the cardiovascular disease market [2] - HengRui's recent licensing of GLP-1 class innovative drugs to a newly established U.S. company could yield up to $6 billion in total payments, indicating a strong focus on expanding its innovative drug portfolio [2]

Core Viewpoint - HengRui Pharma has entered into an exclusive licensing agreement with Braveheart Bio for its Myosin small molecule inhibitor HRS-1893, marking a strategic move to leverage international capital through the NewCo model [1][2] Group 1: Licensing Agreement Details - HengRui Pharma will receive a total of $75 million from Braveheart Bio, which includes a $65 million upfront payment and a $10 million milestone payment upon technology transfer [1] - The agreement allows Braveheart Bio to develop, produce, and commercialize HRS-1893 globally, excluding China, with potential milestone payments reaching up to $1.013 billion related to clinical development and sales [1][4] Group 2: NewCo Model Advantages - The NewCo model allows HengRui to separate R&D risks and commercialization execution, enabling quicker cash flow recovery through upfront and milestone payments [2][6] - This model is particularly suitable for large pharmaceutical companies like HengRui, which have a rich early pipeline but limited overseas clinical and commercialization capabilities [2][5] Group 3: HRS-1893 and Clinical Development - HRS-1893 is a highly selective Myosin small molecule inhibitor aimed at normalizing myocardial contractility and reducing left ventricular hypertrophy [4] - The drug has already initiated Phase III clinical trials for obstructive hypertrophic cardiomyopathy, with multiple clinical trials ongoing in HengRui's cardiovascular portfolio [4][5] Group 4: Strategic Implications - The involvement of reputable investors like Forbion and OrbiMed provides funding and international operational resources, enhancing the credibility of HengRui's technology platform [4][9] - The NewCo model is emerging as a preferred strategy for Chinese pharmaceutical companies to navigate international markets while retaining core regional rights [7][9] Group 5: Market Trends and Future Outlook - The NewCo model has gained traction since 2024, with several companies, including HengRui, exploring this approach to overcome barriers in the global biopharmaceutical market [6][9] - Future pipelines with first-in-class or best-in-class potential are likely to utilize this model for international expansion, necessitating strong collaboration among legal, financial, and medical teams during negotiations [9]

Core Viewpoint - HengRui Medicine has entered into an exclusive licensing agreement with Braveheart Bio for its self-developed Myosin small molecule inhibitor HRS-1893, marking a significant step in the company's international expansion strategy through the NewCo model [1][3]. Group 1: Licensing Agreement Details - The agreement grants Braveheart Bio exclusive rights to develop, produce, and commercialize HRS-1893 globally, excluding mainland China, Hong Kong, Macau, and Taiwan [3]. - Braveheart Bio will pay a total of $75 million, which includes a $65 million upfront payment (comprising $32.5 million in cash and $32.5 million in equity) and a $10 million milestone payment upon completion of technology transfer [3]. - Additionally, HengRui Medicine could receive up to $1.013 billion in milestone payments related to clinical development and sales, along with corresponding sales royalties [3]. Group 2: Product Information - HRS-1893 is a highly selective Myosin small molecule inhibitor that specifically inhibits myocardial ATPase activity, normalizing myocardial contractility, reducing left ventricular hypertrophy, and improving diastolic compliance [4]. - The drug is currently undergoing a Phase III clinical trial in China for obstructive hypertrophic cardiomyopathy and has multiple ongoing clinical trials in the cardiovascular disease field [4]. Group 3: Strategic Implications - The partnership with top-tier life science investment firms like Forbion and OrbiMed highlights HengRui's international competitiveness and the high value of its diversified R&D pipeline [6]. - The collaboration aims to accelerate the global development of innovative therapies in the cardiovascular field, addressing unmet medical needs [6]. - This agreement follows HengRui's previous successful licensing deals, including a notable transaction with GSK, which set a new record for outbound licensing agreements from China [7].