Core Insights - In 2025, China's innovative drug sector is experiencing a significant surge, with 43 innovative drugs approved in the first half of the year, nearing the total approvals for 2024 [1] - China now accounts for approximately one-quarter of the global innovative drug development pipeline, conducting around 3,000 clinical trials annually, placing it at the forefront globally [1] - The total amount for licensing agreements of Chinese innovative drugs has surpassed $100 billion in the first three quarters of 2025, indicating a strong market enthusiasm for domestic innovations [1] - Leading company Heng Rui has established itself as a key player in the innovative drug landscape, focusing on unmet clinical needs and leveraging new technologies for better patient service [1][2] Industry Overview - The Chinese innovative drug industry is reshaping the global biopharmaceutical landscape, transitioning from a "Fast-follower" role to a "First-in-class" and "Best-in-class" approach, led by companies like Heng Rui [2] - The approval speed and quality of innovation in China have significantly improved, with a nearly 60% year-on-year increase in new drug approvals in the first half of 2025 [3] - China has become a major source of global pharmaceutical innovation, with the number of new drug molecules designed in China surpassing those from Europe and the U.S. for the first time in 2024 [3] Heng Rui's Strategy - Heng Rui's innovation strategy focuses on three key areas: patient-centered needs, modular-driven differentiation, and comprehensive chronic disease management [4] - The company is expanding its research platforms to include various advanced technologies such as ADCs, bispecific antibodies, and small nucleic acid drugs, while continuously optimizing these platforms [4] - In oncology, Heng Rui is developing a "four-in-one" collaborative innovation therapy system that encompasses precision therapy, immunotherapy, targeted chemotherapy, and supportive care [5] Global Expansion - By 2025, Chinese innovative drugs accounted for over 20% of global licensing transactions, reflecting a shift in confidence towards China's biopharmaceutical capabilities [6] - Heng Rui has achieved significant milestones in business development (BD), with total licensing agreements exceeding $28 billion over the past three years, partnering with major multinational corporations [6][8] - A notable collaboration with GlaxoSmithKline (GSK) involved a record-breaking licensing deal for 12 innovative projects, highlighting the growing recognition of Chinese companies' research capabilities [7] Future Outlook - Heng Rui anticipates over 10 innovative drugs and approximately 20 new indications to be approved domestically within the next two years, while also exploring new BD transactions and enhancing global clinical capabilities [8] - The Chinese innovative drug sector is expected to see a wave of projects launched in major global markets, accelerating the globalization of domestic companies [10] - Heng Rui's transformation is attributed to sustained high R&D investment, with a research expense ratio reaching 30%, and a robust pipeline of over 100 innovative products in clinical development [11]

Core Insights - The Chinese medical insurance directory will undergo its largest expansion of innovative drugs in history starting January 1, 2026, adding 114 new drugs, including 50 class 1 innovative drugs, while removing 29 drugs that are either unavailable or can be replaced by better alternatives [1][9] - The new directory will increase the total number of drugs to 3,253, significantly enhancing coverage for key areas such as oncology, chronic diseases, mental health, rare diseases, and pediatric medications [1][9] - The inclusion of innovative drugs in the medical insurance directory reflects a strong commitment to support genuine innovation and differentiated innovation in the healthcare sector [1][9] Medical Insurance Directory Expansion - The new medical insurance directory will include 114 new drugs, with nearly 44% being class 1 innovative drugs, indicating a growing emphasis on innovative treatments [1][2] - The directory aims to balance the clinical value of innovative drugs, corporate profits, and the sustainability of the insurance fund, with a new commercial insurance directory established for high-cost innovative drugs [2][15] - The entry of innovative drugs into the medical insurance directory is seen as a critical step in making these treatments accessible to patients, thereby reducing their economic burden [13][23] Market Dynamics and Trends - The inclusion of innovative drugs in the medical insurance directory is expected to accelerate sales growth for these products, reshaping the business models of Chinese innovative drug companies [4][20] - Companies like Hengrui Medicine and Innovent Biologics have successfully included multiple innovative products in the new directory, indicating a trend of increasing market access for innovative therapies [4][5] - The commercial insurance directory, which includes 19 innovative drugs, aims to provide additional support for high-cost treatments, potentially lowering patient treatment costs significantly [15][18] Focus on Key Therapeutic Areas - The new directory emphasizes significant clinical value and urgent patient needs, particularly in oncology, with new drugs targeting various types of cancers being added [10][11] - The inclusion of drugs for rare diseases and conditions like severe asthma highlights a commitment to addressing critical healthcare challenges faced by patients [16][17] - The directory also includes innovative treatments for chronic conditions such as diabetes, further expanding access to essential therapies for a large patient population [8][12] Policy and Regulatory Environment - Recent reforms in drug approval and medical insurance payment systems have created a conducive environment for the development of innovative drugs in China [19][20] - The acceleration of drug review processes and the establishment of a more rigorous value assessment framework are expected to enhance the accessibility of innovative treatments [19][22] - The collaboration between policy and capital markets is crucial for fostering innovation and ensuring the sustainability of the healthcare system [21][22] Future Outlook - The successful implementation of the new medical insurance directory is anticipated to restore investor confidence in the innovative drug market, which has seen a slowdown in investment interest recently [18][21] - The ongoing development of commercial insurance options for innovative drugs is expected to play a significant role in expanding patient access and improving treatment outcomes [18][19] - The transition from merely making innovative drugs available to ensuring they are affordable and effective represents a significant shift in the Chinese healthcare landscape [23][24]

Core Insights - The National Medical Insurance Drug List for 2025 includes 11 anti-tumor products from Heng Rui Medicine, with 5 innovative drugs newly added to the national insurance directory, enhancing accessibility for patients [1] - Heng Rui's oncology division has developed a differentiated product matrix covering various high-incidence tumors, including immunotherapy and targeted therapy [1][5] Group 1: New Drug Inclusion - Five innovative drugs newly included in the insurance directory are: - Injection of Rukang Trastuzumab (Aivida®) - Injection of Phronolapitan Palonosetron (Ruitanning®) - Malic Acid Famitinib Capsules (Aibite®) - Acetate Abiraterone Tablets (II) (Airiji®) - Liposomal Irinotecan Injection (II) (Yueyouli®) [1][2] - These drugs address long-standing treatment gaps in various cancers, providing improved accessibility and efficacy for patients [1][2] Group 2: Expanded Indications - Three existing drugs in the insurance directory have expanded indications: - Fluorouracil Capsules (Airiyi®) now includes treatment options for breast cancer patients with specific genetic markers - Apatinib Tablets (Aitan®) have new indications for combination therapy - Injection of Carrelizumab (Airika®) is now indicated for recurrent/metastatic cervical cancer [3][4] Group 3: Long-term Drug Continuity - Three key products have successfully renewed their insurance coverage, ensuring continuous access for patients: - Pyrotinib Tablets (Airini®) for HER2-positive breast cancer - Hecoriparib Ethanolamine Tablets (Hengqu®) for immune thrombocytopenia and severe aplastic anemia - Sulfapeginterferon Injection (Aido®) for reducing infection risk in chemotherapy patients [4][5] Group 4: Overall Coverage - Out of 16 innovative drugs launched by Heng Rui, 14 have been included in the national insurance directory, achieving near-complete coverage of innovative results [5] - The company aims to continue focusing on patient needs while expanding its technological platforms and diverse pipeline to meet unmet clinical demands [5]