新药周观点：口服GLP-1小分子糖尿病3期临床成功，胰岛素前用药全程口服化可期-20250420

Investment Rating - The report maintains an investment rating of "Outperform the Market - A" for the biopharmaceutical sector [5]. Core Insights - The recent positive results from Eli Lilly's oral GLP-1 small molecule Orforglipron in Phase 3 clinical trials (ACHIEVE-1) are significant for diabetes treatment, potentially increasing the number of oral medications available before insulin use [2][15]. - The global market for GLP-1 drugs is substantial, with projected sales of approximately $51.8 billion in 2024, of which $37.71 billion (73%) is for diabetes products and $14.06 billion (27%) for obesity products, indicating strong future growth potential for oral GLP-1 small molecules [20][21]. Summary by Sections Weekly New Drug Market Review - From April 14 to April 20, 2025, the top five companies in the new drug sector by stock price increase were: Boan Biotechnology (68.01%), Fuhong Hanlin (18.71%), Junsheng Tai (16.20%), Nothland (11.00%), and Yifang Biotechnology (10.48%). The top five companies with stock price declines were: Youzhiyou (-21.19%), Beihai Kangcheng (-16.57%), Aidi Pharmaceutical (-9.48%), Geely Pharmaceutical (-7.84%), and Haishike (-7.54%) [1][11]. Key Analysis of the New Drug Industry - Eli Lilly's Orforglipron demonstrated a significant reduction in HbA1c levels, with an average decrease from a baseline of 8.0% to between 1.3% and 1.6%. Over 65% of patients achieved an A1C level of ≤6.5%, and patients lost an average of 7.9% of their body weight during the trial [15][16]. New Drug Approvals and Applications - This week, three new drugs or new indications were approved for market entry in China, with 299 new drug INDs approved and 38 new drug INDs accepted for review [3][24]. Domestic New Drug Industry Highlights - On April 18, 2025, Kangfang Biologics' monoclonal antibody injection for IL-12/IL-23 received NMPA approval for psoriasis treatment [4]. - On April 17, 2025, BeiGene's new BCL2 inhibitor was prioritized for review for chronic lymphocytic leukemia and small lymphocytic lymphoma [4]. Overseas New Drug Industry Highlights - Eli Lilly's Orforglipron Phase 3 trial results were announced on April 18, 2025 [7]. - On April 16, 2025, Eisai and Biogen's Leqembi for Alzheimer's disease received EU approval [7]. - On April 14, 2025, Bristol-Myers Squibb's PD-1 inhibitor was approved by the FDA for liver cancer treatment [7].