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Lepu Biopharma to Resubmit NDA for Nasopharyngeal Cancer Drug to Chinese Drug Administrator
After supplementing the materials for MRG003, Lepu Biotech-B (02157.HK) reaffirms the NDA and strives to accelerate the上市 process.
On March 4, Gloronghui reported that Lepu Biopharma-B (02157.HK) announced the new drug application (NDA) for its candidate pharmaceutical MRG003, a drug conjugate targeted at the epidermal growth factor receptor (EGFR), for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC). As previously disclosed, the company received the Acceptance Notice from the National Medical Products Administration of China (NMPA) in September 2024, indicating that the NDA for MRG003 has been accepted.
Pharmaceutical stocks generally rose, with KCP Pharmaceutical (02171) increasing by 25.29%. Institutions expect that after the first quarter report, the pharmaceutical Sector is likely to see an overall performance reversal in the Industry.
Jinwu Financial News | Pharmaceutical stocks have generally risen, with Keji Pharmaceutical (02171) up 25.29%, INNOCARE (09969) up 14.58%, REMEGEN (09995) up 12.88%, Yiming Anke (01541) up 12.25%, Lepu Biopharma (02157) up 10.67%, YSB (09885) up 6.88%, and Gushengtang (02273) up 6.71%. The Hong Kong stock Pharmaceutical ETF has risen 3.59%, and the Hong Kong Stock Connect Yinhua CSI Innovative Drugs Industry ETF has risen 4.05%. Ping An Securities stated that on January 17, 2025, the National Healthcare Security Administration will hold a '
BOCOM INTL: AI-driven new opportunities in the onshore pharmaceutical Sector, giving the Industry a "leading" rating.
With the expectation of continued rollout of favorable policies regarding fiscal and medical insurance/commercial insurance, and the overall Sector valuation still at historical lows, BOCOM INTL believes there is still significant room for recovery in the Sector.
The "DeepSeek Moment" of medicine, has China’s Innovative Drugs also reached it?
Over the past four years, China's share of Global large-scale pharmaceutical Trade has surged from 5% to 30%. From research and development innovation to international mergers and acquisitions, Chinese Innovative Drugs companies are reshaping the Global pharmaceutical innovation landscape.
Hong Kong stock movement | Lepu Biopharma-B (02157) rose nearly 7% in early trading after signing an exclusive licensing agreement with ArriVent for MRG007.
Lepu Biotech-B (02157) rose nearly 7% in the morning session, and as of the time of writing, it has increased by 5.07%, priced at 2.9 Hong Kong dollars, with a transaction volume of 12.4945 million Hong Kong dollars.
