The latest: Connect Biopharma (CNTB.US) said on Tuesday its CBP-201 drug candidate achieved all primary and key secondary endpoints in the primary analysis population for a 16-week pivotal trial of the drug in Chinese patients with moderate-to-severe atopic dermatitis.

Looking up: The company expects to approach China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) in the next several months to determine the potential for a new drug application (NDA) filing.

Take Note: During the 16-week treatment period, the incidence of adverse events from the CBP-201 treatment was 73.5%, mainly injection site reactions lasting longer than 24 hours, and conjunctivitis. But none of those led to the study’s termination. The incidence of serious adverse events was 0.6%.

Digging Deeper: Founded in 2012 and listed on the Nasdaq in 2021, Connect Biopharma has three drug candidates for five indications, but has yet to generate drug revenues and reported an operating loss of 402 million yuan ($56.4 million) in the first half of the year, mainly due to 341 million yuan in R&D expenses. The company’s core product, CBP-201, used to treat moderate to severe atopic dermatitis, has completed a Phase 2b clinical trial and is expected to start a global Phase 3 trial by the end of this year. If all goes well, the company will submit a new drug application and could start commercializing the drug in China as early as 2024.

Market Reaction: Following the news, shares of Connect Biopharma plunged 15.3% to $1.11 on Tuesday, with volume surging 42 times from the previous trading day. The stock fell another 2.8% to $1.08 on Wednesday, close to its 52-week low.

Translation by Jony Ho

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