Summary
BeOne Medicines Ltd. (ONC) announced a significant regulatory milestone as the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) for REVLIMID® (lenalidomide) in combination with rituximab. This application seeks approval for the treatment of patients suffering from relapsed or refractory indolent lymphoma, specifically follicular lymphoma or marginal zone lymphoma. This represents a potential expansion of REVLIMID's therapeutic indications in China beyond its current approvals for multiple myeloma.
Key Highlights
- 1NMPA acceptance of sNDA for REVLIMID in combination with rituximab for relapsed/refractory indolent lymphoma (follicular lymphoma, marginal zone lymphoma).
- 2This sNDA aims to expand REVLIMID's approved indications in China.
- 3REVLIMID is already approved in China for multiple myeloma (since 2013) with label expansions in 2018.
- 4The drug is marketed in China by BeiGene under an exclusive license from Celgene Logistics Sarl (a Bristol-Myers Squibb company).
- 5This development signals potential new revenue streams and market opportunities for BeiGene in the Chinese oncology market.
- 6The filing includes the full press release announcing this regulatory update as an exhibit.