将投中网设为"星标⭐"，第一时间收获最新推送 港股发行新规成政策东风。 作者丨 海若镜 来源丨 36氪Pro 港交所门口，排满了等待上市的创新药企。 9月28日，小核酸药企靖因药业递表港股IPO，上轮投后2.5亿美元。9月15日至今两周间，已有爱 科百发、新元素药业、先为达等六家创新药企加入港股IPO冲刺队伍。 今年4月映恩生物上市以来，沉寂多时的港股创新药板块，被高频的BD交易、汹涌的IPO热潮激活。 维立志博、银诺医药新股公开发售部分都获得超3000倍认购，出现上市首日股价翻一倍、两倍的表 现，扭转了此前三年药企到港股"上市即破发"的窘境。 "边走边看，祈祷行情可以持续，"一家近期递表药企的IR负责人说道。待上市药企，普遍渴望能抓 住这一波上市机会。 "现在大家都觉得很紧迫。因为市场很热，发行窗口难得，谁也不确定等自家通过聆讯时，行情是什 么样。"科律律师事务所上海办事处主管合伙人刘毅铭表示，"另外，当前创新药横向竞争也比较激 烈，像代谢领域，已有多家开发GLP-1靶点的药企上市，还有几家正在推进中。市场上能看懂创新 药的二级市场投资人，本身就有限，如果他投了竞品，可能不一定有胃口再投同赛道的另一家企 业 ...

来源：新浪基金 连续5日调整后，港股通创新药板块今日（9月22日）迎来反弹！100%创新药研发标的——港股通创新 药ETF（520880）高开后一度上探2.57%，全天红盘震荡，尾盘二次发力，场内收涨1.77%收复5日均 线，全天成交3.31亿元。 37只成份股涨跌参半，MIRXES-B暴涨27.68%居首，权重股信达生物涨2.88%，康方生物、三生制药涨 超1%。下跌方面，乐普生物-B、君实生物分别跌5.1%、4.67%居前。 丰晨成表示，近期我们与多位BD（商务拓展）专家（涉及跨国药企、律所和财务顾问）进行了深度交 流，从反馈来看，目前创新药行业并未受到美国潜在政策的影响，10-11月将进入每年BD交易高峰期， 年内仍有望看到重磅BD交易。 二级市场方面，短期来看，伴随创新药情绪调整，其弹性也有望进一步提升，继续重点看多！创新药核 心资产短期调整或是较好的加仓机会。展望后市，如果四季度出现医药投融资拐点，创新药有望迎来中 美产业共振。目前从上游投融资反馈看，行情有望持续。 【创新药"新势力"——港股通创新药ETF（520880）：不含CXO，纯正创新药，港股高弹性】 港股通创新药ETF（520880）是全 ...

Core Viewpoint - The collaboration between Haizheng Pharmaceutical and Aixin Dawei marks a significant step in China's innovative drug development, reflecting the rapid growth of China's innovative drug business development (BD) transactions from less than 1% of the global share in 2016 to nearly 35% today [1][4]. Company Summary - Haizheng Pharmaceutical has entered into a partnership with Aixin Dawei to introduce a potential first-in-class small molecule conjugate drug, HSE-001 (AST-3424), with a total investment of up to 240 million yuan [1][2]. - The drug AST-3424 targets the AKR1C3 enzyme in tumor cells, selectively activating and releasing a potent DNA damaging agent, showing low toxicity to normal tissues [2]. - This partnership allows Haizheng to fill a gap in its pipeline for innovative drugs targeting solid tumors, enhancing its transition from a generic drug leader to an innovative pharmaceutical company [2][6]. Industry Summary - The innovative drug BD landscape in China is evolving, with a notable increase in the number of BD transactions, reaching 95 by September 2025, which represents 11% of global BD transactions, up from 2% in 2016 [4][5]. - The total transaction value of China's innovative drug BD events reached $89 billion by 2025, accounting for 33% of the global total, a significant increase from less than 1% in 2016 [5]. - The number of heavyweight BD transactions in China has also surged, with 21 transactions by 2025, representing 28% of global heavyweight BD transactions, compared to 0% in 2016 [5]. - The collaboration trend indicates a shift in the pharmaceutical industry from a "large and comprehensive" model to a "specialized and precise" approach, with biotech firms focusing on early-stage research and traditional pharmaceutical companies leveraging their commercialization capabilities [7][8]. - China's biopharmaceutical market is projected to grow significantly, reaching $2,911 billion by 2026 and $3,732 billion by 2030, with approximately 30% of global innovative drugs under development [8].

Investment Rating - The industry rating is "stronger than the market" indicating that the overall return of the industry is expected to exceed the market benchmark index by more than 5% in the next 6 months [6][75]. Core Insights - The report analyzes the impact of the "Biological Safety Act" on the CXO industry and concludes that the BD policies will not have a substantial effect on the innovative drug sector [4][28]. - The CXO companies have shown resilience, with stock prices recovering and reaching new highs despite the changes in the Biological Safety Act [4][17]. - The report emphasizes the advantages of China's innovative drug industry, including talent resources, research efficiency, and cost-effectiveness, which are expected to mitigate the impact of external policies [4][28]. Summary by Sections Market Review - During the week of September 8-12, 2025, the CITIC Pharmaceutical Index fell by 0.3%, underperforming the CSI 300 Index by 1.7 percentage points, ranking 28th among CITIC's primary industry classifications [3][30]. - Year-to-date, the CITIC Pharmaceutical and Biotechnology Index has risen by 27.8%, outperforming the CSI 300 Index by 12.9 percentage points, ranking 8th among CITIC's industry classifications [3][30]. - The top five performing stocks for the week included: Zhend Medical (+41.3%), Haooubo (+28%), Jimin Medical (+25.9%), Kangwei Century (+23.2%), and Ao Jing Medical (+20.5%) [3][44]. Impact of the Biological Safety Act - The report details the evolution of the Biological Safety Act since December 30, 2023, noting that the stock price reactions of representative CXO companies have become desensitized over time, with current prices surpassing levels from December 29, 2023 [4][17]. - The performance of CXO companies in the U.S. market has remained strong, with significant growth in orders and revenue despite the act's implications [24][28]. Investment Focus - The report suggests focusing on three main areas in the innovative drug and its supply chain: companies with revenue and commercialization capabilities, potential BD opportunities based on technological trends, and exploring cutting-edge technologies such as gene therapy and CAR-T [5][28]. - The medical device sector is also highlighted as a key area for investment, with expectations of a policy turning point and improving fundamentals [5][28]. Stock Recommendations - The report recommends a focus on specific stocks including Kangfang Biotech, Baiji Shenzhou, Xinda Biotech, Enhua Pharmaceutical, and others for the upcoming month [5][12].

Core Viewpoint - The Trump administration is preparing a new executive order targeting the Chinese pharmaceutical industry, particularly focusing on the licensing-out (BD) of innovative drugs, which may restrict U.S. pharmaceutical companies from importing new drugs from China and impose stricter reviews on drug licensing transactions and clinical data from China [1][3]. Group 1: Impact on the Market - Following the news, shares of innovative drug companies in both A-shares and H-shares fell, with companies like BeiGene and Rongchang Bio experiencing declines, while the Hang Seng Biotechnology Index saw a significant drop [1]. - Despite initial declines, the innovative drug sector showed signs of recovery, with a partial rebound observed on September 12 [1]. Group 2: Details of the Proposed Executive Order - The draft executive order includes four main points: limiting U.S. pharmaceutical companies from importing in-development drugs from China, requiring licensing transactions to undergo mandatory review by the Committee on Foreign Investment in the United States (CFIUS), enhancing FDA scrutiny on projects using Chinese clinical data, and promoting domestic drug production in the U.S. [3][5]. - The proposed restrictions are seen as a response to the increasing trend of U.S. pharmaceutical companies acquiring Chinese innovative drug pipelines, which has raised concerns among some U.S. investors [3][4]. Group 3: Industry Reactions and Feasibility - Industry insiders express skepticism about the feasibility of the executive order due to the complex interests involved, suggesting that even if the order is implemented, it may only affect the most sensitive areas like cell therapy and human genetic resources, while allowing other transactions to proceed normally [2][6]. - The potential impact of the order on U.S. pharmaceutical companies is significant, as it could limit their access to innovative drugs and hinder their development capabilities [6][7]. Group 4: Economic Implications - The executive order is perceived as a move that could harm both U.S. and Chinese companies, as it may restrict BD transactions that are crucial for innovation and collaboration in the pharmaceutical sector [2][6]. - The financial stakes in BD transactions are substantial, with the potential for significant profits for multinational companies, as evidenced by BioNTech's recent acquisition and subsequent sale of a Chinese innovative drug [7].

Core Viewpoint - The article discusses the significant fluctuations in stock prices of innovative pharmaceutical companies, highlighting both the successes and failures in the market, particularly focusing on the performance of companies that reached historical highs in 2025 and those that have experienced substantial declines. Group 1: Performance of Innovative Pharmaceutical Companies - As of September 11, 2025, 90% of Hong Kong and STAR Market innovative pharmaceutical companies have seen significant stock price increases since the beginning of the year [6] - A total of 17 companies reached historical highs in stock price and market capitalization in 2025, with notable companies including BeiGene (688235.SH) and Innovent Biologics (01801.HK) [7][10] - Among these 17 companies, 12 have entered or are about to enter the commercialization phase, establishing stable revenue sources [7] Group 2: Key Events and Financial Performance - BeiGene and Innovent Biologics achieved their first profits in the first half of 2025, with BeiGene reporting a net profit of approximately 450 million yuan, a significant turnaround from a loss of 2.877 billion yuan in the same period last year [10] - Innovent Biologics reported a net profit of 834 million yuan, benefiting from the growth of PD-1 and other oncology drugs in the domestic market [10] - Other companies like Kintor Pharmaceutical (06990.HK) and Rongchang Biologics (688331.SH) have also made significant progress through BD transactions and drug approvals [11] Group 3: Declining Companies and Market Challenges - Despite the successes, 50% of innovative pharmaceutical companies still have stock prices below their initial offering prices, with 31 out of 55 Hong Kong 18A innovative pharmaceutical stocks experiencing declines [14][15] - Companies like Tengsheng Bo Pharmaceutical (02137.HK) and Akeso (09939.HK) have seen significant drops in stock prices, with some losing over 90% of their value since their IPOs [20][21] - The article notes that many of these declining companies faced challenges such as failed drug trials or adverse market conditions, leading to substantial losses [20][21] Group 4: Recent Trends and Future Outlook - Three companies, including Tongyuan Kang Pharmaceutical (02410.HK), have seen stock price declines of 70% or more since the beginning of the year, indicating ongoing volatility in the sector [25] - The article emphasizes the importance of BD transactions and successful drug approvals as key factors for recovery and growth in the innovative pharmaceutical market [12][22]

Core Viewpoint - The stock prices of several innovative pharmaceutical companies in A-shares and Hong Kong stocks have significantly declined following reports of a potential U.S. government order to restrict American companies from purchasing Chinese drugs under development, although the White House later stated that the government was not actively considering such a draft [2][3]. Group 1: Stock Performance and Market Trends - As of September 11, 2025, 90% of Hong Kong and STAR Market innovative pharmaceutical companies have seen substantial stock price increases since the beginning of 2025, with 17 companies reaching historical highs in stock price and market capitalization [3][6]. - The stock price surge has been driven by the commercialization of innovative drugs, with 12 out of the 17 companies having entered or about to enter the commercialization phase, generating stable revenue [3][6]. - Notably, companies like BeiGene (688235.SH) and Innovent Biologics (01801.HK) achieved their first profits in the first half of 2025, with BeiGene reporting a net profit of approximately 450 million yuan, a turnaround from a loss of 2.877 billion yuan in the same period last year [6][7]. Group 2: Company Highlights - Companies such as Kintor Pharmaceutical (688506.SH) and Hengrui Medicine (09926.HK) have also made significant strides, with Kintor achieving a market capitalization of 139.5 billion yuan [5]. - The stock price of Kintor has risen significantly since its listing, with its stock reaching a peak of 541.5 HKD on September 9, 2025, and a total market capitalization exceeding 110 billion HKD [7]. - Rongchang Biotechnology (688331.SH) has seen its stock price increase by 246% in A-shares and 625% in Hong Kong stocks since the beginning of the year, driven by significant BD transactions [7][8]. Group 3: Market Challenges - Despite the successes of some companies, 50% of innovative pharmaceutical companies still have stock prices below their initial public offering (IPO) prices, with 31 out of 55 Hong Kong innovative pharmaceutical stocks experiencing a decline [8][9]. - The highest rate of stock price decline is observed among companies listed between 2021 and 2023, with over 70% of these companies currently trading below their IPO prices [8][9]. - Companies like Tengsheng Bo Pharmaceutical (02137.HK) and Akeso (09939.HK) have seen their stock prices drop significantly, with declines of 90% or more from their peak prices shortly after listing [12][13].

Core Viewpoint - The Trump administration is considering strict restrictions on the flow of innovative drug pipelines from China, citing concerns over national security and the exploitation of the U.S. regulatory system by foreign entities [3][5]. Group 1: Proposed Policies - A draft executive order is circulating among major pharmaceutical companies and biotech investors, proposing stricter scrutiny for U.S. pharmaceutical companies seeking drug licenses from Chinese biotech firms, requiring evaluations by the National Security Council [3][5]. - The FDA would need to conduct more rigorous reviews of clinical trial data from China, with companies submitting such data facing higher regulatory fees [5][6]. Group 2: Market Impact - Following the news, Chinese biotech stocks experienced significant declines, with BeiGene dropping 10.59% and Zai Lab falling 9.81%, contributing to a 9.91% drop in the overall U.S. listed Chinese pharmaceutical sector [4][5]. Group 3: Industry Trends - Recent months have seen a surge in innovative drug BD transactions from China, with Pfizer prepaying $1.25 billion to a Chinese company for a drug license and AstraZeneca paying $110 million for collaboration on chronic disease drugs [5]. - A report from Jefferies indicated that by Q1 2025, 32% of the total value of biotech licensing deals will come from China, up from 21% in 2023 and 2024, highlighting China's growing influence in the global biopharmaceutical landscape [7][8]. Group 4: Government Stance - The White House has denied actively considering the draft executive order, while discussions are ongoing about expediting the FDA review process to allow pharmaceutical companies to initiate clinical trials more quickly [7][8]. - The Trump administration has previously issued a memo titled "America First Investment Policy," focusing on limiting foreign investment in strategic industries, with China being a primary concern [8][9].

Core Viewpoint - BeiGene, a leading innovative drug company, has entered the innovative drug business development (BD) wave by selling a portion of the royalty rights for a cancer drug for up to $950 million, marking a significant transaction in the Chinese innovative drug sector [1] Group 1: Transaction Details - BeiGene announced the sale of royalty rights for a cancer drug, receiving an upfront payment of $885 million, which accounts for 36% of its revenue for the first half of the year [1] - The drug, Talazoparib, is set to launch in the U.S. in May 2024 for small cell lung cancer treatment, with the overseas sales managed by Amgen [2] - Royalty Pharma, the buyer, expects a return on investment of 10%-15% from this transaction, with total sales of Talazoparib projected to reach $19.6 billion from 2025 to 2035 [3] Group 2: Market Impact and Analysis - The transaction is significant as it is BeiGene's first drug rights sale in four years and introduces a new BD model in the Chinese innovative drug industry, focusing solely on royalty rights [1][5] - Despite the substantial upfront payment, BeiGene's stock did not rise post-announcement, contrasting with other companies that saw stock increases following similar transactions [6] - Analysts suggest that the transaction may not create long-term value for BeiGene, as it resembles a debt financing rather than a value-generating deal [6] Group 3: Financial Position and Future Outlook - BeiGene's CFO emphasized the importance of a robust balance sheet, stating that the transaction enhances operational and strategic flexibility [7] - The company has over 30 drug candidates in its pipeline, with more than 10 in Phase III clinical trials, necessitating significant R&D investment [7] - As of June 30, 2025, BeiGene had approximately $2.8 billion in cash, down $170 million year-over-year, with liabilities around $2.5 billion [7]

Core Viewpoint - The recent BD transaction by BeiGene is perceived as weak in attractiveness for investors, as it does not create value but is akin to a debt financing operation [1][10]. Group 1: Transaction Details - BeiGene announced the sale of partial royalty rights for a cancer drug for up to $950 million, with an upfront payment of $885 million [2][3]. - The upfront payment represents 36% of BeiGene's revenue for the first half of the year [3]. - The drug involved, Talazoparib, is set to launch in the U.S. in May 2024 for small cell lung cancer treatment [5]. Group 2: Financial Implications - The transaction is expected to enhance BeiGene's balance sheet stability and provide a steady cash flow, which is a critical goal for the company [10]. - As of June 30, 2025, BeiGene had approximately $2.8 billion in cash, a decrease of $170 million year-over-year, with liabilities around $2.5 billion [11]. Group 3: Market Reaction and Comparisons - Following the announcement, BeiGene's stock price declined alongside the broader innovative drug sector, contrasting with other companies that saw stock price increases after similar transactions [3][9]. - The transaction structure is unique as it only involves the sale of royalty rights, differing from typical BD transactions that include upfront payments, milestone payments, and royalties over the drug's lifecycle [9]. Group 4: Future Outlook - Royalty Pharma, the buyer, anticipates a return on investment of 10%-15% from this transaction, with projected total sales of Talazoparib estimated at $19.6 billion from 2025 to 2035 [4][7]. - The deal is seen as a significant move for BeiGene, marking its first drug rights sale in four years, and it sets a precedent in the Chinese innovative drug industry [3][10].