转自：北京日报客户端 共8家医药企业排队 截至12月25日，科创板IPO排队的医药企业共有8家，均为以科创板第五套标准申报上市。其中北芯生 命距离上市最近，已注册生效。 上交所官网于12月22日更新了北芯生命的IPO动态，公司科创板IPO已于12月18日注册生效。招股书显 示，北芯生命是一家专注于心血管疾病精准诊疗创新医疗器械研发、生产和销售的国家高新技术企业。 从北芯生命IPO历程可以看出近年来科创板IPO对未盈利医药企业监管态度的变化。回顾北芯生命科创 板IPO历程，公司IPO于2023年3月30日获得受理，随后于当年4月进入问询阶段。随着科创板重启第五 套上市标准审核，北芯生命于今年7月18日上会获得通过，并于7月25日提交注册，目前已注册生效。 作为一家以科创板第五套上市标准申报上市的企业，北芯生命申报IPO之初报告期内净利均为亏损。不 过在IPO排队过程中，北芯生命实现了扭亏。根据公司注册稿，今年一季度，北芯生命实现的营业收入 为1.28亿元，同比增长104.9%；对应实现的归属净利润为2060.61万元，同比实现扭亏。 此外，随着科创板第五套上市标准重启，今年以来，有5家未盈利医药企业科创板IPO ...

随着商业化持续推进，深圳北芯生命科技股份有限公司（以下简称"北芯生命"）已实现扭亏，同时这家 近期注册生效的医疗器械企业也即将进入发行阶段，成为科创板第五套上市标准下医药企业冲刺资本市 场的生动样本。今年以来，随着科创板第五套上市标准审核重启，沉寂一段时间的医药企业科创板IPO 市场迎来新生机。 经统计，年内已有珠海泰诺麦博制药股份有限公司（以下简称"泰诺麦博"）等6家医药企业科创板IPO获 得受理。截至目前，科创板IPO排队医药企业共8家，均为以科创板第五套标准申报上市。值得一提的 是，上海恒润达生生物科技股份有限公司（以下简称"恒润达生"）、哈尔滨思哲睿智能医疗设备股份有 限公司（以下简称"思哲睿"）早在2022年便开始闯关，不过自科创板IPO第五套上市标准重启后，除更 新财务资料外尚未有新进展。 8家药企排队 截至12月25日，科创板IPO排队的医药企业共有8家，均以科创板第五套标准申报上市。其中，北芯生 命距离上市最近，已注册生效。12月22日，上交所官网更新了北芯生命的IPO动态，公司科创板IPO已 于12月18日注册生效。招股书显示，北芯生命为一家专注于心血管疾病精准诊疗创新医疗器械研发、生 产和 ...

随着商业化的持续推进，深圳北芯生命科技股份有限公司(以下简称"北芯生命")已实现扭亏，这家近期注册生效的医疗器械企业即将进入发行阶段，也成为 科创板第五套上市标准下医药企业冲刺资本市场的生动样本。今年以来，随着科创板第五套上市标准审核重启，沉寂了一段时间的医药企业科创板IPO市场 迎来了新的生机。 经统计，年内已有珠海泰诺麦博制药股份有限公司(以下简称"泰诺麦博")等6家医药企业科创板IPO获得受理。截至目前，科创板IPO排队医药企业共有8家， 均为以科创板第五套标准申报上市。值得一提的是，上海恒润达生生物科技股份有限公司(以下简称"恒润达生")、哈尔滨思哲睿智能医疗设备股份有限公司 (以下简称"思哲睿")早在2022年就开始闯关，不过自科创板IPO第五套上市标准重启后除更新财务资料外尚未有新进展。 | 公司全称 | 上海恒润达生生物科技股份有限公司 | 受理日期 | | --- | --- | --- | | 公司简称 | 恒润达生 | 融资金额(亿 | | 审核状态 | 中止(财报更新) | 更新日期 | | 保荐机构 | 中国国际金融股份有限公司 | 保存代表人 | | 会计师事务所 | 容诚会计师事务 ...

（来源：北京商报） 随着商业化的持续推进，深圳北芯生命科技股份有限公司（以下简称"北芯生命"）已实现扭亏，这家近期注册生效的医疗器械企业即将进入发行阶段，也成 为科创板第五套上市标准下医药企业冲刺资本市场的生动样本。今年以来，随着科创板第五套上市标准审核重启，沉寂了一段时间的医药企业科创板IPO市 场迎来了新的生机。 经统计，年内已有珠海泰诺麦博制药股份有限公司（以下简称"泰诺麦博"）等6家医药企业科创板IPO获得受理。截至目前，科创板IPO排队医药企业共有8 家，均为以科创板第五套标准申报上市。值得一提的是，上海恒润达生生物科技股份有限公司（以下简称"恒润达生"）、哈尔滨思哲睿智能医疗设备股份有 限公司（以下简称"思哲睿"）早在2022年就开始闯关，不过自科创板IPO第五套上市标准重启后除更新财务资料外尚未有新进展。 | 公司全称 | 上海恒润达生生物科技股份有限公司 | 受理日期 | | --- | --- | --- | | 公司简称 | 恒润达生 | 融资金额(亿 | | 审核状态 | 中止(财报更新) | 更新日期 | | 保荐机构 | 中国国际会融股份有限公司 | 保荐代表人 | | 会计师事务所 ...

Core Insights - Shanghai's manufacturing output in the three leading industries grew by 8.5% year-on-year in the first three quarters of this year, outpacing the overall industrial output growth by 2.8 percentage points [1] - The pharmaceutical sector, particularly the export of medicines and raw materials, saw significant growth, with exports increasing by 21.5% and 40.7% respectively [1] Group 1: Industry Growth and Development - Shanghai has positioned its biopharmaceutical industry as a pillar industry, with plans to develop a world-class biopharmaceutical cluster by 2025, aiming for an industry scale exceeding 1 trillion yuan [2] - The biopharmaceutical industry in Shanghai has shown consistent growth, with the scale increasing from 761.71 billion yuan in 2021 to an expected 984.70 billion yuan in 2024, reflecting a compound annual growth rate of 8.94% [2] - The manufacturing output in the biopharmaceutical sector is projected to grow from 171.20 billion yuan in 2021 to 201.17 billion yuan in 2024, with a compound annual growth rate of 6.9% [2] Group 2: Enterprise and Investment Landscape - By the end of 2024, Shanghai is expected to have 2,183 biopharmaceutical enterprises, with significant presence from global industry leaders [3] - Shanghai has established a biopharmaceutical industry mother fund with a total scale of 22.5 billion yuan, which has completed the selection of 13 sub-funds, achieving a leverage effect of 5.59 times [3] - In the biopharmaceutical sector, Shanghai has seen cumulative financing of 238.37 billion yuan from 2021 to 2024, with 255.31 billion yuan raised in the first nine months of this year alone [3] Group 3: Market Expansion and Innovation - As of September 2025, there are 102 biopharmaceutical companies listed on A-shares, Hong Kong stocks, and US stocks, indicating a growing capital market presence [4] - Shanghai's biopharmaceutical sector has a strong innovation output, with 7 first-class innovative drugs and 15 third-class innovative medical devices approved in 2024, ranking second and first nationally respectively [6] - The city has produced several first-in-class and first-in-China innovative products, including a long-acting GLP-1 receptor agonist and a gene therapy drug for hemophilia B [10][11] Group 4: Future Directions and Focus Areas - The biopharmaceutical industry in Shanghai is expected to continue focusing on cutting-edge innovations, particularly in areas such as dual antibodies, ADCs, cell gene therapy, and AI applications in medicine [12] - The industry aims to support disruptive innovations and cultivate benchmark products in both pharmaceuticals and medical devices [12]

Core Insights - The National Healthcare Security Administration (NHSA) has published the preliminary review results for the 2025 medical insurance and commercial insurance innovative drug directory, with significant changes in the approval status of six drugs compared to the previous version [1][2]. Summary by Categories Drug Approval Changes - Six drugs have had their approval status changed, with two drugs (Injectable Risperidone Microspheres and Injectable Triptorelin Acetate) being disapproved, while two others (Levodopa Injection and Calcium Gluconate Sodium Chloride Injection) have been approved [1][3]. - The oral suspension of Ursodeoxycholic Acid remains approved, but the conditions for approval have been adjusted [1][3]. Application Statistics - For the 2025 directory adjustment, the NHSA received 718 applications, involving 633 drug generic names, with 535 passing the preliminary review [1][2]. - The approval rate has increased significantly, reaching 84.52% this year, compared to 68.42% in 2023 and 76.66% in 2024 [2]. Notable Drugs - Levodopa Injection, used for Parkinson's disease, has been approved and is not an exclusive product, indicating its potential for broader market access [4]. - Injectable Ceftriaxone Sodium Sulbactam, another approved drug, is noted for its broad antibacterial spectrum and safety profile [4]. - The oral suspension of Ursodeoxycholic Acid has had its approval conditions modified to include rare disease categories [6]. Innovative Drug Directory - The commercial insurance innovative drug directory has been introduced alongside the basic medical insurance directory, with 141 applications received, of which 121 passed the preliminary review [2]. - A significant number of drugs in both directories are new, with 303 in the basic medical insurance directory meeting specific conditions for approval [7]. Rare Disease Drugs - The directories include a total of 37 rare disease drugs in the basic medical insurance directory and 35 in the commercial insurance innovative drug directory, with 19 drugs approved in both [10][11]. - Notable rare disease drugs include those from Merck and other companies, which have gained attention for their potential market impact [11][12]. Market Trends - The introduction of the commercial insurance innovative drug directory is expected to enhance market access for several high-profile drugs, including CAR-T therapies that have previously struggled to gain approval [9][12]. - The performance of rare disease drug companies has seen significant stock price increases, indicating strong market interest and potential for growth [13].

Core Viewpoint - The National Healthcare Security Administration (NHSA) has officially announced the preliminary review results for the adjustment of the 2025 medical insurance and commercial insurance innovative drug catalog, indicating an increase in the number of drugs passing the review and the overall approval rate compared to previous years [1][2]. Summary by Relevant Sections Drug Review Changes - Six drugs underwent changes in their review status, with two drugs, injectable risperidone microspheres and injectable triptorelin, being disapproved, while injectable levodopa and calcium gluconate sodium injection were approved [1][5][6]. - The injectable risperidone microspheres, an exclusive product of Shengzhao Pharmaceuticals, was first launched in mainland China in February 2025 for treating mental disorders [6][7]. - The injectable triptorelin, also an exclusive product, was launched in 2023 for treating prostate cancer and precocious puberty [7]. Approval Statistics - A total of 718 applications were received for the 2025 catalog adjustment, involving 633 drug generic names, with 535 passing the preliminary review, resulting in an approval rate of 84.52% [1][2]. - The approval rates have shown a significant increase over the past three years, with 68.42% in 2023, 76.66% in 2024, and 84.52% in 2025 [2]. Innovative Drug Catalog - The commercial insurance innovative drug catalog was introduced for the first time, with 141 applications received, involving 141 drug generic names, and 121 passing the review [3]. - Among the drugs, 79 were submitted for both the basic medical insurance catalog and the commercial insurance innovative drug catalog [3]. Notable Products - Several notable products are highlighted, including CAR-T products that have previously failed to enter the medical insurance catalog but are now included in the commercial insurance innovative drug catalog [11][12]. - Unique products such as the first and only AKT inhibitor and the only Trop-2 ADC for breast cancer treatment are also included in the catalogs, indicating a focus on innovative therapies [13][14]. Rare Disease Medications - The review process has also included rare disease medications, with 37 drugs in the basic medical insurance catalog and 35 in the commercial insurance innovative drug catalog, of which 19 are approved in both [15][16]. - The approval of rare disease drugs is seen as a significant development, with companies like Beihai Kangcheng gaining attention for their innovative products [20].

Core Insights - The article discusses the challenges and opportunities faced by innovative drug companies in China, particularly in relation to pricing strategies and market access for CAR-T therapies [1][2][3] Pricing Strategies - Innovative drug companies are experiencing a significant pricing gap between domestic and international markets, with some drugs priced 20 to 30 times higher abroad compared to China [1][2] - The introduction of a dual directory system for insurance coverage, including a commercial insurance directory for innovative drugs, aims to enhance pricing confidentiality and improve patient access [9][11] Market Dynamics - There is a trend of local innovative drug companies shifting their focus to overseas markets, which may impact their competitiveness in China and the benefits to domestic patients [2][7] - The average time for innovative drugs to be included in the national insurance directory has decreased from around 5 years to approximately 1 year, with 80% of new drugs entering the directory within two years of launch [6][8] Regulatory Environment - The National Healthcare Security Administration (NHSA) has been implementing a price confidentiality mechanism since 2019, with the proportion of companies requesting non-disclosure of negotiation prices rising from under 50% in 2019 to over 70% in 2022 [3][4] - Despite the introduction of price confidentiality, there are concerns about the effectiveness of these measures in practice, particularly during the distribution and procurement phases [4][5] Future Outlook - The article highlights the need for improved regulatory frameworks to support innovative drug pricing strategies, especially as China becomes a more prominent market for new drug launches [7][10] - The potential for innovative payment models, such as risk-sharing agreements, is discussed as a way to enhance the sustainability of innovative drug pricing while maintaining confidentiality [10][11]

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [2] Core Insights - The pharmaceutical and biotechnology industry index increased by 4.90%, ranking third among 31 primary industries, outperforming the CSI 300 index, which decreased by 0.09% [4][15] - The sub-industries of medical research outsourcing and vaccines saw significant gains of 12.70% and 6.59%, respectively, while blood products and offline pharmacies lagged with increases of only 0.35% and 2.41% [4][15] - As of August 1, 2025, the overall PE (TTM) for the pharmaceutical and biotechnology industry was 30.97x, up from 30.09x in the previous period, indicating an upward valuation trend [4][21] - The top three sub-industries by PE (TTM) are vaccines (62.06x), hospitals (38.94x), and other biological products (38.44x), while the lowest valuation is in pharmaceutical circulation (16.12x) [4][21] Industry Review - The National Medical Products Administration (NMPA) is seeking public opinion on the "Regulations on the Filing Management of Internet Drug and Medical Device Information Services" [6] - The State Council's news office held a press conference discussing multiple measures for drug price management [6] - Bristol-Myers Squibb's "Nivolumab Injection" combined with "Ipilimumab Injection" received NMPA approval, marking it as China's first approved dual immune therapy for lung cancer [6] - The total transaction amount for innovative drug BD in China exceeded 60 billion USD in the first half of 2025, indicating a significant market shift towards platform-based pipeline output [7] Investment Recommendations - The National Healthcare Security Administration (NHSA) has clarified a "reverse inward competition" direction in the 11th batch of centralized procurement, promoting a shift from price competition to a quality-first and reasonably priced ecosystem [7] - The report suggests focusing on companies with "true innovation" capabilities, strong barriers (complex formulations/high-end device domestic replacements), platform-based operations, and internationalization [7]

Investment Rating - The report maintains an investment rating of "Outperform the Market - A" [4] Core Insights - The innovative drug sector has seen a significant increase in institutional interest, with the total heavy positions in Biotech innovative drugs reaching 80.371 billion yuan, a quarter-on-quarter growth of 39% [7][18] - The proportion of heavy positions in Biotech innovative drugs relative to the overall market has increased to 2.39%, up by 0.49 percentage points, indicating sustained enthusiasm from institutions towards the innovative drug sector [19][25] - The heavy positions in Biotech innovative drugs account for 24.93% of the total heavy positions in the pharmaceutical industry, reflecting a rise of 5.49 percentage points [19][25] Summary by Sections Weekly Review of New Drug Market - From July 28 to August 1, 2025, the top five companies in the new drug sector by stock price increase were: Zhongsheng Pharmaceutical (29.53%), WuXi AppTec (17.72%), CSPC Pharmaceutical Group (14.60%), Maiwei Biotech (12.08%), and Haizhi Pharmaceutical (11.76%) [14][15] - The top five companies by stock price decrease were: Kintor Pharmaceutical (-19.09%), Hualing Pharmaceutical (-16.19%), Junsheng Pharmaceutical (-13.24%), Kintor Pharma (-12.70%), and Yunding New Drug (-11.29%) [14][15] Key Analysis of New Drug Industry - The report analyzed the latest heavy positions of all funds in the innovative drug sector as of June 30, 2025, focusing on A-share and Hong Kong Biotech companies [18] - The heavy positions in Biotech innovative drugs accounted for 7.05% of the total market capitalization, an increase of 0.93 percentage points [23][28] New Drug Approval and Acceptance - This week, 13 new drug or new indication applications were approved, including drugs such as Risperidone orally disintegrating film and Nivolumab injection [33][34] - Additionally, 6 new drug or new indication applications were accepted, including drugs like Eptinezumab injection and Edaravone tablets [35][36] Clinical Application Approval and Acceptance - A total of 50 new drug clinical applications were approved this week, while 44 new drug clinical applications were accepted [37]