The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to provide Clover Biopharmaceuticals Ltd. with an additional $36.9 million to support development of SCB-2019, a recombinant trimeric Spike-protein subunit COVID-19 vaccine.
Top-line results of Daiichi Sankyo Co. Ltd.’s phase III Quantum-First study, testing the addition of quizartinib to chemotherapy vs. chemotherapy alone for adults with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML), found the combination therapy provided a “statistically significant and clinically meaningful improvement” in overall survival vs. standard treatment alone, meeting the trial’s primary endpoint, Ken Takeshita, global head of R&D at Daiichi Sankyo, told BioWorld.
LONDON – Sosei Heptares is to get $100 million up front in a potential $2.6 billion deal with Neurocrine Biosciences Inc., in which the pair will develop muscarinic receptor agonists in the treatment of schizophrenia, dementia and other neuropsychiatric disorders. San Diego-based Neurocrine is taking rights to a portfolio of small molecules against specific subtypes of the muscarinic receptor family, targeting M1 and M4 alone, plus a dual M1/M4 agonist.
Ono Pharma Korea Co. Ltd. has received approval in South Korea for Velexbru (tirabrutinib hydrochloride), its oral Bruton’s tyrosine kinase (BTK) inhibitor, as treatment of recurrent or refractory B-cell primary central nervous system lymphoma.
Aptose Biosciences Inc. has bought over the worldwide rights to Hanmi Pharmaceutical Co. Ltd.’s myeloid kinome inhibitor in a deal worth up to $420 million. Seoul, South Korea-based Hanmi has granted Aptose exclusive worldwide rights to HM-43239 for all indications. The candidate was developed for relapsed or refractory acute myeloid leukemia.
Sichuan Clover Biopharmaceuticals Inc. raised HK$2.03 billion (US$260.17 million) in its Hong Kong Stock Exchange debut. Shares closed at HK$12.98 (US$1.67) on Nov. 5 after trading as high as HK$13.56 earlier.
Plants could be an alternative vaccine platform for both COVID-19 and future pandemics, shaking up a biologics sector that is currently mostly protein-based. South Korean company Bioapplications Inc., for example, is aiming to have a plant-derived booster shot for COVID-19 in the clinic in 2022.
Antengene Corp. Ltd. has formed a partnership with Legochem Biosciences Inc. to jointly develop new antibody-drug conjugates (ADCs) primarily for cancer. The partners will integrate antibodies from Antengene with Legochem’s ADC technology.
Cerecin Inc. has raised $40 million in an oversubscribed round of financing, paving the way for a potential listing in South Korea. Proceeds of the financing will fund the expansion of the company’s current studies and support the planning and initiation of a global phase III study of its lead candidate, tricaprilin, in Alzheimer’s disease.
China’s Center for Drug Evaluation (CDE) released a draft guide on clinical trials of drugs for rare disease as part of an ongoing push to encourage new drug development and nudge developers to focus on biomarkers, pharmacometrics and patient-reported outcomes. Both are needed to continue moving China’s R&D capabilities up the value chain and closer to being on par with the capabilities of other countries that are at the forefront of new drug development.
RSS
