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]