Sam Chun Dang Pharm(000250) said on the 23rd that it would discuss ways to enter Japan with an oral generic of Wegovy. It has not received generic approval in Japan. If it fails to clear the tough regulatory hurdle, it could quickly turn into a negative.
Sam Chun Dang Pharm says it is developing a generic of semaglutide, the active ingredient in oral Wegovy, on its own platform. In connection with this, it disclosed that on Jan. it signed a sales agreement with Daiichi Sankyo Espha.
Sam Chun Dang Pharm plans to discuss the timeline for when to apply to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan for generic approval. If it clears the approval hurdle in Japan, Sam Chun Dang Pharm will supply the product and Daiichi Sankyo Espha will handle sales.
The sales agreement in Japan with Daiichi Sankyo Espha is effectively half-baked. The contract includes a condition that if generic approval is not obtained from the Pharmaceuticals and Medical Devices Agency during development, Daiichi Sankyo Espha may terminate the agreement within 18 months.
Earlier, Sam Chun Dang Pharm said it had held prior consultations with the U.S. Food and Drug Administration (FDA) on the generic development process. In the United States, whether a generic is approved is decided through review such as an abbreviated new drug application (ANDA). The company only received a response to a Pre-ANDA, which discusses development plans before filing an ANDA. It has not yet applied for approval.