55款罕见病用药获批上市，210条罕见病药物研发管线临床试验，累计超90种罕见病用药进医保……罕 见病领域正成为我国医药产业热门赛道。 政策开路，罕见病新药上市步伐加快 得益于强有力的政策手段，近年来我国罕见病药物研发供应速度明显加快。据统计，截至2022年11月 底，共有治疗45种罕见病的89种药物在国内获批。2023年起，药物上市步伐明显提速：根据国家药品监 督管理局发布的药品审评报告，2023年我国共批准45个罕见病药品上市；2024年继续"踩油门"，获批的 罕见病药品达到55个品种，其中20个品种通过优先审评审批程序得以加快上市。 进入2025年，罕见病药物加速上市的趋势仍在延续。据不完全统计，仅在今年5月，就有至少4款罕见病 新药获国家药品监督管理局批准上市。其中包括诺华申报的盐酸阿思尼布片，复星医药（600196）的芦 沃美替尼片，北海康成的注射用维拉苷酶β，泽璟制药的盐酸吉卡昔替尼片。 此外，还有多款药物上市在即。例如默克近期宣布，国家药品监督管理局药品审评中心（CDE）已正式 受理其1类创新药Pimicotinib的上市许可申请，用于需要系统性治疗的腱鞘巨细胞瘤（TGCT）成人患 者。 "每一 ...

Core Viewpoint - The implementation of the "K8 Measures" has led to a renewed focus on the fifth listing standard for unprofitable biotech companies on the STAR Market, aiming to enhance the financing environment for innovative drug firms and shift A-share valuation logic towards "technological value" and "commercial prospects" [1][5][15] Group 1: K8 Measures and STAR Market - The "K8 Measures" were introduced by the China Securities Regulatory Commission (CSRC) to support high-quality, unprofitable tech companies with key technologies and market potential to list on the STAR Market [1] - Since the introduction of the K8 Measures, two unprofitable hard tech companies have been accepted for listing, but the specific "Standard Five" for unprofitable innovative drug companies has yet to be activated [1][3] - The CSRC has reiterated its commitment to promoting the new cases under the fifth listing standard, which is expected to accelerate the financing pace for biotech companies [1][3] Group 2: Impact on Biotech Companies - Biotech companies, particularly innovative drug firms, face longer investment periods and greater uncertainty due to strict approval processes, making them highly dependent on capital [1][5] - The fifth listing standard has previously allowed 20 unprofitable biotech companies to list, with 19 of them successfully bringing 45 self-developed drugs/vaccines to market [3][5] - The introduction of the fifth standard has significantly shortened the capital cycle for these companies and has contributed to the prosperity of the biopharmaceutical primary market [3][5] Group 3: Commercialization and Financial Performance - As of 2024, the 20 companies that listed under the fifth standard collectively achieved revenues of 14.21 billion yuan, a year-on-year increase of 44.17%, with four companies expected to surpass 1 billion yuan in revenue in the coming years [12] - Companies like Ailis and Shenzhou Cell have reported significant revenue growth and profitability, attributing their success to continuous R&D investment and effective commercialization strategies [12][13] - The revised "STAR Market Attribute Evaluation Guidelines" for 2024 emphasize the importance of commercialization capabilities and revenue growth for companies seeking to list [11] Group 4: Future Prospects and Challenges - The market is keenly observing which companies will benefit first from the reactivation of the fifth listing standard, with five companies currently under review [14] - Companies with strong technological innovation capabilities and significant market potential are expected to be the first beneficiaries of the new standard [14][15] - The fifth listing standard presents both opportunities and challenges for unprofitable companies, requiring them to demonstrate their technological strengths and market potential despite not being profitable [15]

Core Viewpoint - The Chinese innovative pharmaceutical industry is experiencing a significant breakthrough, marked by a surge in new drug approvals and business development (BD) transactions, leading to a re-evaluation of the sector's market value and a shift in investor expectations towards stable dividends [1][3][11]. Group 1: Market Dynamics - The innovative drug sector in China has seen a strong rise in the secondary market, with the A-share and Hong Kong stock markets' innovative drug indices increasing by 32.79% and over 70% respectively from April 8 to June 16 [3][4]. - Notable individual stocks, such as Shuyou Pharmaceutical and Changshan Pharmaceutical, have seen their prices double, with Shuyou's stock price increasing by over 500% since April 8 [3][6]. - The core drivers of this market rally include active BD transactions and the commercialization of innovative drugs, as investor sentiment shifts from pessimism to optimism regarding domestic medical demand [3][4]. Group 2: Regulatory and Policy Support - The National Medical Products Administration (NMPA) has been actively optimizing the clinical trial review and approval process for innovative drugs, aiming to enhance the efficiency of drug development and reduce time to market [1][10]. - Recent policy changes are expected to further support innovative drug research and development, with a focus on clinical value [10][11]. Group 3: Business Development Trends - Chinese innovative pharmaceutical companies are increasingly engaging in BD transactions, with a record-breaking upfront payment of $12.5 billion from Pfizer to 3SBio for an ADC pipeline, highlighting the growing interest from international firms [7][8]. - The first quarter of 2025 saw a significant increase in License-out transactions, with 41 deals totaling $369.29 billion, indicating a shift in funding strategies for innovative drug companies [8][9]. - The trend of License-out has become a primary funding source for unprofitable innovative drug companies, allowing them to monetize their pipelines amid a challenging financing environment [8][9]. Group 4: Commercialization and Profitability - The commercialization of innovative drugs is gaining momentum, with 20 new class 1 innovative drugs approved in the first five months of the year, setting a record for the past five years [10][11]. - Leading innovative pharmaceutical companies are reaching breakeven points, with companies like BeiGene expected to achieve positive operating profits by 2025, marking a significant milestone for the industry [11][12]. - As companies begin to realize profits, their negotiating power in BD transactions is increasing, allowing them to retain more favorable terms in agreements with international partners [12][13]. Group 5: Competitive Landscape - The competition in the innovative drug sector is intensifying, particularly in the ADC and bispecific antibody platforms, with over 100 companies entering the PD-1/PD-L1 space, leading to a crowded market [13][14]. - Companies are focusing on developing First-in-Class pipelines to differentiate themselves and avoid the pitfalls of homogenous competition [13][14]. - The need for innovative drug companies to enhance their clinical and commercialization capabilities is critical for competing on a global scale and reducing reliance on international partners [14][15].

截至10:09，港股通创新药ETF(159570)标的指数前十大权重股多数飘绿：药明生物跌超5%，消息面上，主要股东WuXi Biologics Holdings Limited拟每股26.6 港元配售8294万股现有股份，占股约2.04%，涉资约22.07亿港元。配售价较上周五收市价28港元折让5%。百济神州、中国生物制药跌超1%，信达生物微 跌，康方生物涨超5%。 【创新药催化不断！持续看好创新药投资机会】 随着国产创新药的临床数据和临床进度在全球范围内的竞争力越来越强，创新药出海的趋势不断加强。继5月20日三生制药与辉瑞就PD-1/VEGF双抗 （SSGJ-707）达成的交易首付款再次刷新国产创新药出海纪录（首付款）后，石药集团于5月30日公告，3项潜在交易正在进行磋商，每项潜在交易项目的 总交易额均可能达到50亿美元。 今日，港药大幅波动，港股通创新药ETF(159570)早盘一度跌1.5%后快速拉起转为涨超2%，随后冲高回落涨幅收窄，成交额已大幅爆量超15亿元，规模和 流动性大幅领先同类！资金面持续火热，港股通创新药ETF(159570)盘中再获净流入近2亿元，截至6月13日近9日已累计"吸金"18 ...

□ 本报记者杨彦 近日，国家药监局官宣发布，批准11款创新药上市，其中江苏获批5款创新药。据统计，今年以来江苏 已获批7款国产1类创新药。 百济神州(苏州)生物科技有限公司申报的注射用泽尼达妥单抗，适用于既往接受过全身治疗的HER2高 表达(IHC3+)的不可切除局部晚期或转移性胆道癌患者。 江苏恒瑞医药（600276）股份有限公司申报的1类创新药苹果酸法米替尼胶囊，该药联合注射用卡瑞利 珠单抗用于既往接受含铂化疗治疗失败但未接受过贝伐珠单抗治疗的复发或转移性宫颈癌患者。 江苏泰康生物医药有限公司申报的注射用阿格司亭α，适用于成年非髓性恶性肿瘤患者在接受容易引起 发热性中性粒细胞减少症的骨髓抑制性抗癌药物治疗时，降低以发热性中性粒细胞减少症为表现的感染 发生率。 今年以来，省药监局全面深入贯彻《国务院办公厅关于全面深化药品医疗器械监管改革促进医药产业高 质量发展的意见》，着力打造医药产业发展的政策高地、服务高地、创新高地、质量高地。年初，省药 监局制定《关于持续深化药品医疗器械监管改革优化"面对面"对接服务助力医药产业高质量发展的工作 方案》，全系统深入摸排、组织座谈会、实地走访等形式，优化"一品一专班"服务 ...

Core Viewpoint - The pharmaceutical sector in both A-shares and Hong Kong has shown significant performance, with innovative drug stocks being a key driver of growth, particularly due to external licensing transactions and favorable policies supporting the industry [4][13]. Group 1: Market Performance - The A-share pharmaceutical and biotechnology sector rose by 1.13%, ranking 17th among 31 industries [4]. - In the Hong Kong market, the healthcare index increased by 4.11%, and the biotechnology index rose by 4.52%, outperforming the Hang Seng Index, which gained 2.16% [4]. - The innovative drug sector has seen a substantial increase in external licensing transactions, with a total of $45.5 billion in transactions from January to May 2025, accounting for over 30% of the global total [4][5]. Group 2: Company Developments - The company reported potential transactions that could yield up to $5 billion in upfront and milestone payments, with one transaction expected to complete by June [5]. - The innovative drug sector has been active since a record licensing deal by a major pharmaceutical company on May 20, which has led to increased activity in the sector [4]. Group 3: ETF and Fund Performance - The largest pharmaceutical ETFs in China include the Huabao Medical ETF with a size of 25.9 billion yuan and the E Fund Medical ETF with 20.8 billion yuan, with respective year-to-date gains of 0.92% and 3.32% [9][11]. - The largest innovative drug ETFs are the GF Fund Hong Kong Innovative Drug ETF, the Yinhua Fund Innovative Drug ETF, and the Bosera Fund Hang Seng Medical ETF, with sizes of 9.889 billion yuan, 9.662 billion yuan, and 8.436 billion yuan respectively [9][11]. Group 4: Future Outlook - The innovative drug sector is expected to maintain its growth momentum, driven by policy support, global competitiveness, and the realization of commercial profits [13]. - The demand for innovative drugs is anticipated to recover by 2025, with improvements expected in the medical services and OTC sectors [13].

[Table_Reportdate] 2025年06月03日 [table_invest] 超配 行 业 周 报 杜永宏 S0630522040001 dyh@longone.com.cn 证券分析师 赖菲虹 S0630525050001 lfhong@longone.com.cn 联系人 付婷 futing@longone.com.cn [table_stockTrend] -25% -17% -8% 1% 10% 18% 27% 24-05 24-08 24-11 25-02 申万行业指数:医药生物(0737) 沪深300 [相关研究 table_product] 1.重磅BD交易再次带动创新药热度 — — — — 医 药 生 物 行 业 周 报 （2025/05/19-2025/05/25） [Table_NewTitle 创新药密集上市， ] 关注后续医保谈判 ————医药生物行业周报（2025/05/26-2025/06/01） [table_main] 投资要点： ➢ 市场表现： 上周（05月26日-05月30日）医药生物板块整体上涨2.21%，在申万31个行业中排第 2位，跑赢沪深300指数3. ...

[Table_Reportdate] 2025年06月03日 [table_invest] 超配 行 业 周 报 杜永宏 S0630522040001 dyh@longone.com.cn 证券分析师 赖菲虹 S0630525050001 lfhong@longone.com.cn 联系人 付婷 futing@longone.com.cn [table_stockTrend] -25% -17% -8% 1% 10% 18% 27% 24-05 24-08 24-11 25-02 申万行业指数:医药生物(0737) 沪深300 ➢ 市场表现： 上周（05月26日-05月30日）医药生物板块整体上涨2.21%，在申万31个行业中排第 2位，跑赢沪深300指数3.29个百分点。年初至今，医药生物板块整体上涨6.61%，在申万 31个行业中排名第6位，跑赢沪深300指数9.02个百分点。当前医药生物板块PE估值为 27.98倍，处于历史中位水平，相对于沪深300的估值溢价为137%。子板块涨幅前三的为 化学制药(申万)、生物制品(申万)、医疗服务(申万)，涨幅分别为3.83%、3.14%、2.46%。 个股方面，上 ...

Market Overview - The last trading day before the Dragon Boat Festival saw a volume contraction in the two markets, with the pharmaceutical sector experiencing a broad rally, particularly in Alzheimer's, innovative drugs, and CROs [1] - Several stocks, including Ruizi Pharmaceutical, Wanbangde, and Hainan Haiyao, hit the daily limit up [1] - The pork and chicken sectors also saw a rise, while bank stocks remained active, with Hangzhou Bank and Chengdu Bank reaching new historical highs [1] Banking Sector - Despite the strong performance of bank stocks, a sell-off occurred in multiple bank stocks towards the end of the trading session, indicating a potential profit-taking behavior ahead of the holiday [8] - Regional banks like Hangzhou Bank and Chengdu Bank attracted end-of-day funds due to their earnings elasticity, but this was not enough to offset the selling pressure from larger state-owned banks [8] - The banking sector has been a focus for investors this year, driven by increasing risk aversion, and is expected to remain a key market theme post-holiday [8] Pharmaceutical Sector - On May 29, the National Medical Products Administration approved 11 innovative drugs for market entry, a notably rare occurrence [10] - Among these, five were from innovative companies listed on the Sci-Tech Innovation Board, indicating a supportive policy environment for the innovative drug sector [10] - The current valuation of the innovative drug industry stands at a price-to-earnings ratio (TTM) of 27.74, with a 150% premium over the CSI 300 index, suggesting a stable growth outlook despite recent net outflows from the sector [10] Social Security Fund Holdings - A summary of the latest holdings by the Social Security Fund highlights several pharmaceutical stocks, including Wo Wu Biological, Jiuzhou Pharmaceutical, and others, with varying market capitalizations and price-to-earnings ratios [12] - The data indicates a focus on companies with strong growth potential and established market positions within the pharmaceutical sector [12]

Group 1: Resumption of Trading - Guangyang Co., Ltd. has terminated its plan to acquire 100% equity of Ningbo Yinqiu Technology through the issuance of shares and cash payment, leading to the resumption of its stock trading [1] Group 2: Equity Transfer, Buyback, and Private Placement - Shipu Testing plans to transfer a total of 9.5% of its shares to Zhongyiren Fund at a price of 20 yuan per share [2] - Qingniao Fire Protection has repurchased and canceled 12.2592 million restricted shares [2] - Tigermed has canceled 3.9225 million repurchased shares [3] - Shuanglin Co., Ltd. intends to raise no more than 1.5 billion yuan for projects related to rolling screw and joint module industrialization, high-precision CNC grinding machine expansion, and advanced technology research and application center construction [3] Group 3: External Investment and Daily Operations - Pingao Co., Ltd. has signed a contract for computing power resource services worth 397 million yuan [4] - Yiwei Communication plans to establish a wholly-owned subsidiary with an investment of 100 million yuan, focusing on artificial intelligence application software development [5] - Longjing Environmental Protection intends to acquire 20% equity of Jitai Intelligent for 75.075 million yuan [6] - Tianwei Video Technology has signed a data center service agreement with a client [7] - Fengmao Co., Ltd. plans to invest no more than 1.5 billion yuan to build an auto parts production base in Jiaxing [8] - ST Pioneer will have its stock delisted from other risk warnings starting June 3, 2025, with its stock name changing from "ST Pioneer" to "Pioneer New Materials" [8] - Maiwei Bio has received approval for the marketing of its product, Mai Li Sheng® [8] - Guangbai Co., Ltd. has completed the business registration of its duty-free goods company [9] - Zhuhai Guanyu has been selected by SAIC Volkswagen as a designated supplier for low-pressure lithium batteries [9] - Ningbo Fubang plans to transfer assets related to its aluminum profile business for 26.4579 million yuan [9] - Rongchang Bio has completed the issuance of H-shares [10] - Tebao Bio has received approval for the marketing of its growth hormone injection [10] - Zejing Pharmaceutical has received approval for the marketing of its drug, Hydrochloride Gikaxin [10] - Fengqian Technology has received record approval from the China Securities Regulatory Commission for its overseas H-share issuance [10] - Haida Group plans to distribute at least 30% of its average net profit in cash from 2025 to 2027 [10]