12月7日，国家医保局、人力资源社会保障部印发《国家基本医疗保险、生育保险和工伤保险药品目 录》（以下简称"新版医保目录"）以及《商业健康保险创新药品目录》（2025年）。新版医保目录新增 114种药品，超过了去年（91种），其中50种为一类新药，总体成功率为88%，较2024年的76%也有了 明显提升。 多个"全球新""全国新"进目录 新版医保目录调整后，目录内药品总数增至3253种，肿瘤、慢性病等重点领域的保障水平得到明显提 升。2024年版医保目录新增全球创新药38个，当时为历年来最高数量，今年新版医保目录新增一类创新 药达50种，再创历史新高，其中更是囊括了多款"全球首创""首个国产"类新药。 百事美施贵宝旗下全球首个且目前唯一获批红细胞成熟剂注射用罗特西普此次被纳入了新版医保目录， 用于治疗较低危骨髓增生异常综合征（MDS），这是继成人β-地中海贫血后，罗特西普在中国纳入医 保的第二个适应症。该药今年6月新获批上市，是近20年来首个用于治疗较低危MDS的创新药。天津医 科大学总医院副院长、血液病中心主任付蓉教授表示，罗特西普通过创新作用机制促进红细胞成熟，改 善无效造血，在减轻输血负担、改善贫血和提 ...

Investment Rating - The report maintains a "positive" outlook on the pharmaceutical industry, particularly focusing on innovative drug sectors [3]. Core Insights - The pharmaceutical sector's performance saw a decline of 0.7% this week, while the Shanghai Composite Index rose by 0.4%. The pharmaceutical index ranked 21st among 31 sub-industries [3][4]. - The new National Medical Insurance Drug List added 114 drugs, including 50 innovative drugs, with an overall success rate of 88%, significantly up from 76% in 2024. The first commercial health insurance innovative drug list includes 19 drugs, enhancing coverage for critical areas such as cancer and chronic diseases [3][12][14]. - The establishment of the Chinese Drug Price Registration System allows companies to self-declare innovative drug prices, facilitating global pricing strategies for innovative drugs [17][18]. Market Performance - The pharmaceutical index's valuation stands at 29.3 times earnings, ranking 10th among 31 primary industries [6]. - The performance of various sub-sectors includes: raw materials (-2.5%), chemical preparations (-0.9%), and medical devices (-0.9%), while medical circulation saw an increase of 6.5% [6][4]. Recent Key Events - The report highlights significant clinical trial results from companies like Junsheng Pharmaceutical, which demonstrated advantages in glycemic control and cardiovascular benefits with its new drug HTD1801 [25]. - The report notes the strategic partnership between Kelun Pharmaceutical and Crescent for developing ADC therapies, with potential milestone payments reaching up to $1.25 billion [27][28]. - The report also mentions the IPO application of Lingke Pharmaceutical, focusing on innovative small molecule drugs for autoimmune and inflammatory diseases, with a post-investment valuation of 3.42 billion yuan [30]

Investment Rating - The report maintains a positive outlook on the innovative drug sector and recommends focusing on companies with strong performance in medical devices, CXO, and upstream sectors [3][4]. Core Insights - The report highlights a 0.7% decline in the Shenwan Pharmaceutical Bio Index, while the Shanghai Composite Index rose by 0.4% during the same period [3][4]. - The new National Medical Insurance Drug List added 114 drugs, including 50 innovative drugs, with an overall success rate of 88%, significantly up from 76% in 2024 [3][13]. - The launch of the Chinese Drug Price Registration System allows companies to self-declare innovative drug prices, enhancing the global pricing strategy for these drugs [19][21]. - Recent clinical trial successes and milestone payments indicate a robust pipeline for several companies, including a $250 million milestone payment received by BaiLi Tianheng [26][29]. Market Performance - The Shenwan Pharmaceutical Bio Index ranked 21st among 31 Shenwan first-level sub-industries, with a current overall valuation of 29.3 times earnings, placing it 10th among all first-level industries [3][4][6]. - Various sub-sectors showed mixed performance, with medical circulation and offline pharmacies seeing increases of 6.5% and 1.8%, respectively, while raw materials and chemical preparations declined by 2.5% and 0.9% [3][6]. Recent Key Events - The report notes the release of the first Commercial Health Insurance Innovative Drug Directory, which includes 19 drugs aimed at enhancing coverage for critical diseases and rare conditions [13][18]. - The FDA's drug review center director's resignation adds uncertainty to the regulatory environment, which may impact drug approvals and market dynamics [19][21]. - The report emphasizes the importance of monitoring flu vaccine stocks and related pharmaceutical companies as flu activity rises [22]. Company Dynamics - BaiLi Tianheng received a significant milestone payment, indicating strong progress in its global drug development efforts [26]. - Junsheng Pharmaceutical announced positive results from a head-to-head clinical trial, showcasing the advantages of its new drug HTD1801 over existing treatments [29]. - Heng Rui Pharmaceutical appointed a new senior vice president from Eli Lilly, enhancing its research and development capabilities [30]. - Kelong Botai entered a strategic partnership to develop and commercialize new cancer therapies, indicating a focus on innovative treatment options [31]. IPO Dynamics - Lingke Pharmaceutical has initiated its IPO process in Hong Kong, focusing on innovative small molecule drugs for autoimmune and inflammatory diseases [34]. - Hansi Aitai's IPO application has passed the hearing process, indicating strong market interest in its dual-function antibody therapies [36].

Core Insights - The national medical insurance negotiation for 2025 has introduced a dual-directory system, marking a significant change in the negotiation process for innovative drugs and commercial insurance [1][2][15] - The negotiation process for innovative drugs has seen a price reduction range suggested by the National Medical Insurance Administration (NMIA) of 15% to 50%, with a focus on the CAR-T drugs [3][4] - The introduction of the innovative drug directory is expected to create a more sustainable market payment mechanism for new drugs, with companies needing to reassess their product positioning and market strategies [15] Summary by Sections National Medical Insurance Negotiation - The negotiation took place from October 30 to November 3, 2025, with the first three days dedicated to the national medical insurance directory and the last two days for the commercial insurance innovative drug directory [1] - This year marks the first introduction of an innovative drug directory, which has altered the negotiation dynamics for drug pricing [1][15] Price Negotiation Mechanism - The NMIA has introduced a new price negotiation mechanism for innovative drugs, allowing for price discussions between drug companies and commercial insurance [1][3] - Companies have been advised to consider a price reduction of 15% to 50% during negotiations, with some expressing skepticism about achieving reductions below 15% [3][4] CAR-T Drugs - CAR-T drugs have been a focal point in the negotiations, with successful negotiations reported for some products, such as the CAR-T drug from HeYuan Biotech priced at 999,000 yuan [3][4] - A limited number of CAR-T drugs are expected to be included in the innovative drug directory, with estimates suggesting around 20 drugs may be approved [1][3] Commercial Insurance Dynamics - The dual-directory negotiation allows companies to choose between reporting to the basic medical insurance directory, the innovative drug directory, or both, creating strategic options for different companies [2][10] - The commercial insurance market has shown limited interest in covering rare disease drugs due to their high costs and small patient populations, which may affect their inclusion in the innovative drug directory [14][15] Focus on ADC and Bispecific Antibodies - ADC (Antibody-Drug Conjugates) and bispecific antibodies remain key focus areas in the negotiations, with several innovative drugs vying for inclusion in the directories [8][10] - Companies are adopting varied strategies based on their market positioning, with some prioritizing the basic medical insurance directory for broader market access, while others focus on maintaining high-end product positioning through the innovative drug directory [10][11]

Core Viewpoint - Kolon Pharmaceutical's subsidiary, Kolon Biotech, has received acceptance for the marketing application of the new drug, Furmasan Lunbotin Capsules, aimed at treating RET fusion-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults [1][4]. Group 1: Drug Development and Clinical Trials - Lunbotin (A400/EP0031) is a second-generation small molecule selective RET inhibitor developed by Kolon Biotech, showing broad activity against common RET gene fusions and mutations, which may help overcome resistance seen with first-generation inhibitors [4]. - Kolon Biotech has conducted several key clinical studies for Lunbotin, including pivotal trials for first-line and second-line treatment of advanced RET fusion-positive NSCLC, as well as studies for RET fusion-positive medullary thyroid carcinoma (RET + MTC) and solid tumors [4]. Group 2: Market Trends and Company Performance - The anti-tumor drug market is experiencing robust growth, with sales in hospitals projected to exceed 120 billion yuan in 2024, reflecting a year-on-year increase of 6.15% [7]. - Kolon Biotech has successfully developed and commercialized several anti-tumor and immune modulators, including the first-class new drug, Tagolizumab Injection (PD-L1), and the antibody-drug conjugate, Lukanosatuzumab Injection [9]. - In the first half of 2025, Kolon Biotech reported revenues of 950 million yuan, with self-commercial sales amounting to 310 million yuan, representing 32.6% of total revenue [12].

Core Viewpoint - The adjustment of the national medical insurance and commercial health insurance drug directories is a significant event for the innovative drug investment landscape in the second half of the year, with over 650 drugs entering the basic medical insurance directory and commercial insurance innovative drug directory [1][2]. Group 1: Medical Insurance Directory Adjustments - A total of 534 drug generic names passed the initial review for the basic medical insurance directory, with 310 drugs being added to the directory, a significant increase from 249 in 2024 [2]. - The directory adjustments allow newly approved innovative drugs to have the opportunity to enter the insurance directory, including several notable drugs such as the lung cancer drug Gorailis and the autoimmune drug Fuanqi [2]. Group 2: Commercial Health Insurance Directory - The commercial health insurance innovative drug directory has approved 121 drugs, including five CAR-T therapies and a domestic vaccine, marking a new approach for market access for preventive biological products [3]. - Notable CAR-T therapies that made it into the directory include products from Fosun Kite, Huyuan Bio, and WuXi AppTec, with the latter's product achieving $808 million in revenue in the first half of the year, reflecting a doubling in growth [3]. Group 3: Future Outlook for Innovative Drugs - The upcoming months will see significant overseas pharmaceutical conferences and further developments in the medical insurance directories, providing ample opportunities for speculation and investment in innovative drugs [4]. - The domestic innovative drug sector is expected to benefit from increased clinical data catalysts and a rebound in funding and secondary market activity, enhancing the demand for new drug development [4].