Juniper Biologics Pte. Ltd. has added another candidate to its pipeline in the space of less than a month. In the latest deal, the Singapore-based company inked an exclusive licensing agreement with Switzerland’s Helsinn Healthcare SA, gaining rights to develop and commercialize oncology drug infigratinib in Australia, New Zealand, Southeast Asia and certain markets in the Middle East and Africa.
Hansoh Pharmaceutical Group Co. Ltd. has acquired greater China rights to oncology candidate NKT-2152 from Nikang Therapeutics Inc. in a deal worth up to $218 million. Jiangsu, China-based Hansoh picked up exclusive rights to develop and commercialize the candidate in mainland China, Hong Kong, Macau and Taiwan. In turn, Nikang is eligible to receive $15 million up-front cash payment, as well as up to $203 million in potential development, regulatory and sales-based milestone payments, and tiered royalties.
Beigene Ltd. reported that its global phase III trial of PD-1 inhibitor tislelizumab in combination with chemotherapy met the primary endpoint of overall survival in first-line advanced esophageal cancer.
Connect Biopharma Holdings Ltd. pointed to positive secondary endpoint data and a numerical trend on the primary endpoint in favor of its S1P receptor modulator, CBP-307, in ulcerative colitis, but those results weren’t enough to keep the stock (NASDAQ:CNTB) from falling by more than 57% to close at 82 cents, as investors focused on the primary endpoint miss and the company’s decision to partner the program going forward.
A quartet of companies on May 2 announced three complete response letters (CRLs) that left them scrambling to get back on the path to approval. Hutchmed Ltd.'s surufatinib met with word from the U.S. FDA that two positive phase III studies in China and a bridging study in the U.S. would not support approval of the drug for pancreatic and extra-pancreatic neuroendocrine tumors. A multi-regional clinical trial in the U.S. is needed, the regulator said, brushing aside China-only studies when seeking a U.S. approval.
New trial results presented by Shionogi & Co. Ltd. at the 32nd European Congress of Clinical Microbiology and Infectious Diseases showed the company’s 3CL protease inhibitor, S-217622, was well-tolerated, with the potential to rapidly clear SARS-CoV-2, Simon Portsmouth, executive medical director at Shionogi, told BioWorld.
Ashvattha Therapeutics Inc. secured $69 million in a series B financing that it said will strengthen its ability to develop hydroxyl dendrimer-based medicines and accelerate efforts to advance its candidates to the clinic.
Arrowhead Pharmaceuticals Inc. and Vivo Capital LLC have launched a joint venture named Visirna Therapeutics for RNA interference therapeutics in the greater China market. Arrowhead is the majority shareholder of the new entity, while Vivo invested $60 million in the new entity.
Australia’s Therapeutic Goods Administration will begin conducting routine risk-based good clinical practices (GCP) inspections for clinical trials of drugs and biologics. The agency outlined in final guidance how it would prioritize inspections, what the process would look like and how it would report and follow up on inspections.
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