Tianfeng Securities·2025-06-09 05:15Industry Rating - The industry rating is maintained at "Outperform" [3] Core Insights - Breakthrough therapies (BTD) are defined as drugs that demonstrate significant and reliable clinical significance, aimed at accelerating the treatment of serious diseases or conditions that severely impact the quality of life [4][6] - As of June 4, 2025, a total of 126 domestic innovative drugs have been approved for BTD by CDE, with a trend of expanding from traditional targets like PD-1 and HER2 to emerging targets such as PD-1/IL-2 and BCL2 [4][13] - The potential for overseas expansion of BTD drugs is notable, with 25% of domestic BTD molecules having successfully entered international markets, compared to only 1% of all domestic molecules [28][29] Summary by Sections Breakthrough Therapy Overview - Breakthrough therapies were introduced in China in 2020 to expedite the development of drugs for serious diseases with no effective treatment options [4][6] - The dynamic shift in breakthrough therapies shows a diversification of targets and companies involved, with emerging biotech firms gaining traction alongside established pharmaceutical companies [4][5] Market Potential and Opportunities - The report highlights the increasing global competitiveness of domestic molecules due to their inclusion in the BTD program, which indicates commercial viability and clinical advantages [5][28] - Companies like Kolon Biotech, 3SBio, and others have made significant strides in international markets, achieving record high upfront payments and total deal values [29][30] Clinical Progress and Distribution - As of June 4, 2025, 171 products have been approved for BTD, with 126 being domestic innovative drugs, and a significant number of these are progressing well in clinical trials both domestically and internationally [13][17] - The distribution of BTD approvals shows that companies like Hengrui Medicine lead with 17 approvals, followed by Innovent with 10 and CSPC with 8 [17][18] Target and Molecule Types - The majority of BTD drugs are small molecules, with 49 approved, followed by monoclonal antibodies and antibody-drug conjugates (ADCs), which are gaining popularity [14][23] - Emerging targets such as B7-H4 and B7-H3 are being explored, indicating a trend towards innovative therapeutic approaches [20][23] Future Outlook - The report identifies potential BTD candidates for international expansion based on their clinical progress and whether they have received BTD certification in the U.S. [31][32] - The analysis suggests that the ongoing development of BTD drugs will continue to align with international market trends and demands, enhancing their global market presence [24][28]