创新药研究框架之2024年医保谈判前瞻：国谈进入常态化阶段，创新药长期放量可期

Investment Rating - The industry investment rating is "Outperform the Market - A" [5] Core Viewpoints - The national negotiation for medical insurance has entered a normalization phase, and long-term growth for innovative drugs is expected. The 2024 medical insurance negotiation is anticipated to start soon, with multiple domestic innovative drugs participating [1][9] - Approximately 41 domestic innovative drugs are expected to participate in the new drug negotiations this year, including 28 newly approved drugs from July 1, 2023, to June 30, 2024, and 13 drugs approved before July 1, 2023 [1][20] Summary by Sections 1. Overview of 2024 Domestic Innovative Drug Medical Insurance Negotiation - The negotiation mechanism for drugs in China has gradually entered a normalization phase since 2017, maintaining an annual frequency. The 2024 medical insurance drug negotiation is expected to enter the negotiation/bidding phase soon [9] 1.1. Overall Workflow - The 2024 national drug directory adjustment process consists of five stages: preparation, application, expert review, negotiation/bidding phase, and announcement of results [10] 1.2. Renewal Rule Changes - The renewal rules for negotiated drugs have entered a normalization phase, with no significant changes compared to 2023. The rules have been refined to include provisions for the management of payment standards for drugs nearing the expiration of their first bidding cycle [12] 1.3. Initial Negotiation Price Reduction - Historically, drugs entering the medical insurance directory through negotiation have required an average price reduction of 50-60%. The overall average reduction for this year's negotiation is expected to be similar to previous years [18] 1.4. Drug Negotiation Situation - Approximately 41 domestic innovative drugs are undergoing new drug negotiations, with 28 newly approved drugs and 13 previously approved drugs participating [20] 2. Key Drug Negotiation Situations 2.1. PD-1/PD-L1 Drugs - About 10 PD-1/PD-L1 drugs have passed the formal review, while 10 others will not participate in the negotiation [26] 2.2. Third-Generation EGFR TKI - Beida Pharmaceutical's Beifu Tini is expected to negotiate for first-line treatment of NSCLC [34][36] 2.3. HER2 ADC and Small Molecules - AstraZeneca's Deruxtecan is expected to participate in the negotiation for HER2-positive breast cancer treatment [42][43] 2.4. PCSK9 Drugs - Innovent Biologics' Tolecizumab is expected to participate in the negotiation for primary hypercholesterolemia [47][48] 2.5. EGFR Exon20ins NSCLC Drugs - Dize Pharmaceutical's Shuwotini is expected to participate in the negotiation for NSCLC with EGFR exon20 insertion mutations [53][54] 2.6. Multiple Myeloma Drugs - Haisco's Epinephrine is expected to participate in the negotiation for multiple myeloma treatment [59][60] 2.7. Sleep Medications - Jingxin Pharmaceutical's Dazisni is expected to participate in the negotiation for insomnia treatment [65][66] 2.8. CAR-T - Four CAR-T drugs have passed the formal review and are expected to participate in the negotiation [70][71] 3. Key Company Negotiation Situations 3.1. Heng Rui Pharmaceutical - Heng Rui has several products, including Taji Liding and Oterconazole, participating in new drug negotiations [72][73] 3.2. Bei Da Pharmaceutical - Bei Da's Beifu Tini is expected to negotiate for first-line treatment of NSCLC [75] 3.3. Di Zhe Pharmaceutical - Di Zhe's Shuwotini and Golixitin are expected to participate in new drug negotiations [77] 3.4. Kang Fang Biologics - Kang Fang's Cardunilumab and Yivocizumab are expected to participate in new drug negotiations [78] 3.5. China National Pharmaceutical - China National Pharmaceutical has multiple products, including Yifeng Ake and An Naike, expected to participate in new drug negotiations [79] 3.6. Haisco - Haisco's Koglitin and Cligablin are expected to participate in new drug negotiations [81] 3.7. Bei Ji Shen Zhou - Bei Ji Shen Zhou's Zebutinib and Trelizumab are expected to participate in new indication negotiations [82] 3.8. Innovent Biologics - Innovent's Tolecizumab and Sepitinib are expected to participate in new drug negotiations [85] 3.9. Hansoh Pharmaceutical - Hansoh's Amatinib is expected to undergo renewal negotiations [86] 3.10. Other A-Share Innovative Drugs - Various other A-share innovative drugs are expected to participate in new drug negotiations [88] 3.11. Other H-Share Innovative Drugs - Various other H-share innovative drugs are expected to participate in new drug negotiations [90] 4. Recommended Focus Stocks - Recommended stocks include A-share companies such as Bei Da Pharmaceutical, Heng Rui Pharmaceutical, Di Zhe Pharmaceutical, and others, as well as H-share companies like Kang Fang Biologics and others [92]