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The US FDA has granted IND clearance to initiate a P-IIa trial of 9MW1911 for the treatment of patients with mod. to sev. chronic obstructive pulmonary disease (COPD)
In the China P-IIa trial (n=80) vs PBO, 9MW1911 showed dose-proportional exposure & dose-dependent efficacy, with the RP2D (n=30) reducing mod. to sev. COPD exacerbations by…
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Mabwell has dosed its first patient with Bulumtatug Fuvedotin (BFv or 9MW2821) in P-I trial for the treatment of TNBC pts
Trial will assess safety & efficacy of BFv in TNBC pts previously treated with a taxane & an ADC with a topoisomerase inhibitor payload, measuring ORR as the 1EP
Bulumtatug Fuvedotin, a Nectin-4–targeting…
Mabwell's subsidiary T-mab has signed a licensing deal with Qilu Pharmaceutical for Albipagrastim alfa (R&D code: 8MW0511) across Greater China
As per the deal, Mabwell will grant Qilu exclusive rights to develop, manufacture, improve, utilize, and commercialize Albipagrastim alfa in Greater China(including the Chinese Mainland, Hong Kong, Macau, and Taiwan). T-mab will receive up to…
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The results from the P-III trial comparing MW032’s (SC, Q4W, until wk. 49) safety, efficacy & PK vs reference drug (denosumab) to treat patients (n=708), randomized 1:1, with solid tumors having bone metastasis are published in JAMA Oncology
The 1EP includes percentage change in natural logarithmic transformed urinary N-telopeptide/creatinine ratio (uNTx/uCr) from baseline to…
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Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients
During the month of April, Sandoz’s Hyrimoz (biosimilar, adalimumab) received EC’s…

