On September 9, the MVA strain of the monkeypox attenuated live vaccine independently developed by Shanghai Institute of Biological Products, China National Pharmaceutical Group Corporation (Sinopharm), received the clinical trial notification issued by the National Medical Products Administration. This is the first monkeypox vaccine in China to be approved for clinical trials.On September 9, the NMPA website showed that the listing application for Otsuka Pharmaceutical's Ponatinib Tablets had been approved for: 1) Chronic Myeloid Leukemia (CML) patients with resistance or intolerance to prior medications; 2) Relapsed or refractory Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL); 3) T315I-positive Chronic Myeloid Leukemia (CML) or T315I-positive Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL).On September 9, Yingtai Biotechnology announced that the first-in-human Phase 1/2a study (NCT06554795) of its bispecific antibody-drug conjugate (ADC) DB-1419, developed based on its proprietary DIBAC platform for advanced/metastatic solid tumors, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) and Clinical Trial Notification (CTN) approval from the Australian Therapeutic Goods Administration (TGA). The global first patient dosing has been successfully completed.On September 9, the CDE website announced that CHIATAI TIANQING's Class 1 new drug TQC3721 Inhalation Powder has been approved for clinical trials, intended for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). According to publicly available information from CHIATAI TIANQING, TQC3721 is a PDE3/4 dual inhibitor.Investment and Financing Pharmaceutical AffairsOn September 9, Candid Therapeutics announced the completion of a $370 million financing round, dedicated to developing innovative drugs for autoimmune diseases. Candid Therapeutics also announced the acquisition of Vignette Bio and TRC004, obtaining the former's BCMA/CD bispecific antibody and the latter's CD3/CD20 bispecific antibody. Vignette Bio is a NewCo company established by EpimAb Biotherapeutics authorizing EMB-06 and Foresite, while TRC 2004 is a NewCo company formed by Genor Biopharma authorizing GB261 with Two River and Third Rock.Recently, Junhe Alliance BioPharmaceutical (Hangzhou) Co., Ltd., after receiving 100 million yuan in B-round financing from the listed company Tonghua Dongbao at the end of May this year, completed another B+-round financing of over 200 million yuan just over three months later, bringing the total financing amount to nearly 350 million yuan. The proceeds from this round of financing will mainly be used to further advance the development of the company's R&D pipeline, deepen its presence in both serious medical and consumer healthcare sectors, and accelerate the industrialization and commercial promotion of the company’s product pipeline.Technology-Driven Drug Research
Recently, Atsena Therapeutics announced that the phase 1/2 clinical trial data of the investigational gene therapy ATSN-101 for patients with Leber congenital amaurosis (LCA1) caused by GUCY2D biallelic mutations has been published in The Lancet. According to the press release, ATSN-101 is the first gene therapy for the treatment of LCA1.[1]Yang, Paul et al.Safety and efficacy of ATSN-101 in patients with Leber congenital amaurosis caused by biallelic mutations in GUCY2D: a phase 1/2, multicentre, open-label, unilateral dose escalation study. The Lancet, Volume 404, Issue 10456, 962 – 970.
