Group 1 - The company demonstrates excellent profitability and operational efficiency, with 2023 H1 revenue of approximately 1.603 billion (up 8.7%) and a 5-year sales revenue CAGR of 18%. The net profit for 2023 H1 is around 630 million (up 18.4%), with a 5-year operating profit CAGR of 102%. The gross margin remains above 75%, and the net profit margin is over 30%, with sales expense ratio below 25% [1] - The company has maintained a strong growth trajectory, with a 5-year CAGR of 14.3% despite policy challenges. The product has a strong brand barrier and patient loyalty, with nearly 80% of sales occurring outside the insurance system. The potential for reshaping the immunotherapy landscape is highlighted, particularly with the combination of IO therapy [1] Group 2 - The company is set to launch multiple innovative products, including Elacestrant, the world's first oral SERD, which is expected to replace Fulvestrant and significantly penetrate the HR+ breast cancer market. The annual new patient group for breast cancer is 400,000, with a peak sales potential of at least 2 billion [2] - The company has established a leading GTP commercialization platform that integrates digital and retail strategies, covering over 2,000 core hospitals. This platform connects doctors, patients, and DTP pharmacies, creating a high user stickiness with over 200,000 registered healthcare professionals and 250,000 patient clients [2] Group 3 - Profit forecasts indicate that the company expects to achieve net profits of 1.014 billion, 1.187 billion, and 1.375 billion for 2023-2025, with current market capitalization corresponding to PE ratios of 7, 6, and 5 for those years. The estimated value of the company is around 20 billion RMB, indicating significant undervaluation [3] - The company is initiating coverage with a "buy" rating based on a sum-of-the-parts valuation method, estimating a net profit of 1 billion for 2023 and assigning a 10x PE to listed products, contributing approximately 10 billion in market value [3]

Core Viewpoint - The 2025 list of prohibited substances has been officially released, including 400 types of drugs, with 9 new additions compared to 2024 [2] Group 1: New Additions to the Prohibited List - Anabolic agents: 95 types (no new additions) [3] - Peptide hormones: 75 types (2 new additions) [3] - Narcotic drugs: 14 types (no new additions) [3] - Stimulants (including psychoactive drugs): 84 types (2 new additions) [3] - Precursor chemicals: 3 types (no new additions) [3] - Medical toxic drugs: 1 type (no new additions) [4] - Other drugs: 128 types (5 new additions) [4] Group 2: Specific New Drugs - The 2 new peptide hormones are: - S519 (No. 159) [6] - S597 (No. 160) [6] - The 2 new stimulants are: - Midodrine (No. 241) [7] - Tisofenacin (No. 265) [7] - The 5 new drugs in the "Other" category are: - Elagolix (No. 323) [7] - MOTS-c (No. 351) [7] - S-107 (No. 375) [7] - S48168 (No. 376) [7] - Hipamine (No. 400) [7] Group 3: Clarification on Semaglutide - Recent claims that Semaglutide is a stimulant are inaccurate, as it is not listed in the 2025 directory [7] - Semaglutide is classified under GLP-1 receptor agonists, which are not included in the 2025 directory [8] - The only related substance in the directory is IGF-1 (Insulin-like Growth Factor 1), which is different from GLP-1 [8] - Semaglutide remains under monitoring programs to observe its impact on athletes, consistent with 2024 arrangements [8]

Core Viewpoint - The 2025 list of prohibited substances has been officially released, including 400 types of drugs, with 9 new additions compared to 2024 [2] Group 1: New Additions to the Prohibited List - The new additions include 2 peptide hormones and 2 stimulants, while other categories have seen various changes [3][4] - The two new peptide hormones are S519 and S597 [6] - The two new stimulants are Midodrine and Tesofensine [7] - Five new drugs have been added under the "Other Drugs" category, including Elagolix and MOTS-c [7] Group 2: Clarification on Semaglutide - Recent claims that Semaglutide is classified as a stimulant are inaccurate, as it is not listed in the 2025 directory [7][8] - Semaglutide is a GLP-1 receptor agonist, and the directory does not include GLP-1 or its analogs [8] - The only related substance in the directory is IGF-1, which is fundamentally different from GLP-1 [8] - Semaglutide remains under monitoring programs to observe its impact on athletes, consistent with 2024 arrangements [8] Group 3: Industry Context - The GLP-1 drugs are a new class of hypoglycemic agents that enhance insulin secretion and suppress appetite, leading to weight loss and blood sugar reduction [15]

Investment Rating - The report maintains an "Outperform" rating for the industry [1] Core Insights - There is an unmet clinical need in HR+/HER2- breast cancer (BC), which accounts for approximately 60-70% of all breast cancer cases globally [2][8] - New mechanism drugs are expected to extend chemotherapy-free survival for HR+/HER2- BC patients, with a focus on overcoming resistance to endocrine therapy (ET) and enhancing the efficacy of CDK4/6 inhibitors [2][40] - The report highlights the potential of various new target molecules and mechanisms to improve patient outcomes and expand market size [2][40] Summary by Sections 1. Unmet Clinical Needs in HR+/HER2- BC - HR+/HER2- BC is the most common subtype of breast cancer, with significant unmet clinical needs, especially for patients with specific mutations [2][8] - Current treatment options, including ET and CDK4/6 inhibitors, are limited for patients who progress after first-line therapy [2][40] 2. Endocrine Therapy: New Mechanism Molecules to Overcome Resistance - New generation oral SERDs and ER PROTACs are promising in overcoming resistance caused by ESR1 mutations [2][40] - The estrogen signaling pathway plays a critical role in breast cancer, and targeting this pathway is essential for effective treatment [13][48] 3. CDK Inhibitors: Partners in ET to Extend Treatment Duration - CDK4/6 inhibitors significantly improve progression-free survival (PFS) when combined with ET in first-line treatment [14][25] - There is a need for new mechanism molecules targeting the CDK-cyclin pathway to address resistance after first-line therapy [2][40] 4. Other New Target Molecules: Potential to Extend Chemotherapy-Free Survival - Activation of the PI3K/AKT/mTOR pathway is a common resistance mechanism in HR+/HER2- BC, with several products already approved for treatment [2][40] - New targets such as KAT6i and ADCs are expected to show advantages over chemotherapy and occupy significant positions in treatment sequences [2][40] 5. Company Analysis - Companies leading in the development of new mechanism drugs include BeiGene, Hansoh Pharmaceutical, Kelun-Botai Biopharmaceutical, and China National Pharmaceutical Group [2][40]