Dimerix Ltd. announced a AU$20 million ($US13.22 million) capital raise following the news that its lead candidate, DMX-200, was successful in a prespecified interim analysis of the efficacy endpoint in its pivotal phase III trial in focal segmental glomerulosclerosis, a rare kidney disease.
Another med-tech acquisition was wiped off the charts after Japan’s Olympus Corp. rescinded the acquisition of South Korean medical device firm Taewoong Medical Co. Ltd. on March 7, after finding “data integrity issues” related to Taewoong’s products.
Sosei Group Corp. is getting €25 million (US$27.3 million) up front in a global collaboration and option-to-license deal with Boehringer Ingelheim GmbH aimed at developing GPR52 agonists, a new target for schizophrenia designed to potentially address positive, negative and cognitive symptoms at the same time.
South Korean biopharmaceutical company Celltrion Inc. submitted a BLA to the U.S. FDA on March 10 to gain approval for its Xolair (omalizumab; Novartis AG) biosimilar, CT-P39, across major indications of asthma, food allergy and chronic spontaneous urticaria.
Yuhan Corp., of Seoul, South Korea, added a new potential cancer drug to its oncology pipeline, licensing a son of sevenless homolog 1 (SOS1) inhibitor co-developed by Cyrus Therapeutics Inc. and Kanaph Therapeutics Inc. for ₩208 billion (US$156.3 million).
Foreign investment in China’s biopharma sector is beginning to pick up after the hit of severe pandemic restrictions, and as Western governments look to revive trading relationships following a spate of diplomatic rows. While the geopolitical tensions remain, the mantra from Europe is not to de-couple, but to de-risk. Following a policy review in 2023, the U.K. government position is that a positive two-way trade and investment relationship with China is “mutually beneficial.”
Shionogi & Co. Ltd., of Osaka, Japan, gained standard approval from Japan’s Ministry of Health, Labour and Welfare for Xocova (ensitrelvir fumaric acid) on March 5, making it the first COVID-19 antiviral to win full approval in the country.
In a move to widen global access to its Qdenga dengue vaccine, Takeda Pharmaceutical Co. Ltd. is partnering with India’s Biological E. Ltd. to manufacture Qdenga (TAK-003).
Pharmaust Ltd.’s monepantel met its primary safety endpoints and showed positive signals of potential efficacy in a phase I trial in patients with motor neuron disease (MND)/amyotrophic lateral sclerosis (ALS). With these results, the company will now progress to a pivotal phase II/III trial by midyear, Pharmaust CEO Michael Thurn told BioWorld.
China’s NMPA has approved Carsgen Therapeutics Holdings Ltd.’s NDA for its B-cell maturation antigen (BCMA)-targeted CAR T-cell therapy, zevorcabtagene autoleucel (CT-053, zevor-cel), for treating adults with relapsed or refractory (r/r) multiple myeloma (MM) who have progressed after at least three prior lines of therapy, including a proteasome inhibitor and immunomodulatory agent.
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