21健讯Daily | 迈威生物董事长兼总经理收到立案告知书；派斯双林生物收到山西证监局行政监管措施决定书

Policy Developments - The new draft of the "Further Optimization of Drug Procurement Policy" has circulated in the industry, emphasizing the procurement of medical consumables alongside drugs, enhancing policy flexibility [1] - Since the implementation of the "4+7" volume-based procurement in 2018, the government has organized 10 batches of drug procurement and 5 batches of high-value medical consumables procurement, successfully procuring a total of 435 types of drugs [1] Drug and Device Approvals - Johnson & Johnson's Guselkumab has received approval for a new indication in China for treating moderate to severe active ulcerative colitis in adults who have inadequate response to traditional therapies or biologics [2] - Fosun Pharma's subsidiary has received FDA approval to conduct clinical trials for LBP-ShC4, a live biotherapeutic product aimed at treating androgenetic alopecia, with a cumulative R&D investment of approximately 0.17 million yuan by April 2025 [3] - Reindeer Biologics announced that its CAR-T cell therapy product, Ikigai, has received orphan drug designation from the Saudi FDA for treating relapsed or refractory multiple myeloma in adults [4] Capital Markets - HAYA Therapeutics has completed a $65 million Series A financing round to accelerate the clinical development of its long non-coding RNA-targeted candidate drug HTX-001 for heart failure [5] Regulatory Actions - Pace Double Forest Biopharmaceuticals received administrative regulatory measures from the Shanxi Securities Regulatory Bureau due to internal control deficiencies and inaccurate information disclosure [6] - Maiwei Biotech's chairman received a notice of investigation from the China Securities Regulatory Commission for suspected short-term trading, which is not expected to significantly impact the company's daily operations [7] - Tibet Weixin Pharmaceutical's subsidiary has withdrawn its drug registration application for a pediatric compound amino acid injection, which is not yet marketed in China [8]