China-based Fujian Kerui Pharmaceutical Co., Ltd. announced that its generic version of Pfizer’s (NYSE: PFE) Rapamune (sirolimus) has received marketing approval from the National Medical Products Administration (NMPA). This approval marks the first domestically produced sirolimus gel in China, indicated for the treatment of facial vascular fibroadenoma associated with tuberous sclerosis.
Drug Profile
The sirolimus gel, a topical mTOR inhibitor, has demonstrated quality and efficacy comparable to the originator product. It is the only available version of sirolimus gel in China, offering a new treatment option for patients with tuberous sclerosis.
Market Context
Until now, Pfizer’s Rapamune has been the sole option for patients requiring sirolimus gel therapy. The approval of Kerui’s generic version is expected to increase accessibility and provide a more competitive pricing option in the market.
Investment Background
In 2021, Shanghai-based medical device giant MicroPort Scientific Corp. (HKEX: 00853) acquired a 45% stake in Kerui Pharma for RMB 111 million (USD 15 million), becoming the company’s largest shareholder. This investment underscores MicroPort’s commitment to expanding its presence in the pharmaceutical sector.-Fineline Info & Tech