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.
Hong Kong Stock Market Midday Review | Hang Seng Index rose 0.24% in the morning session, Mainland Insurance Companies climbed across the board.
Six departments issued a document to promote the entry of medium- and long-term funds into the market. Institutions stated that expectations for improvements on the asset side have significantly increased.
A BD L worth up to 1.2 billion USD! The value potential of Lepu Biopharmaceutical-B (2157.HK) is gradually being realized.
BD is a key path for Innovative Drugs companies to grow and achieve breakthroughs in their development process.
Lepu Grants ArriVent Exclusive License for Anti-Gastrointestinal Drug Outside Greater China
Lepu Biotech - B [02157] is currently reported at 2.71 Hong Kong dollars, up by 13.39%.
As of 09:30, Lepu Biotech - B [02157] reported 2.71 HKD, up 0.32 HKD or 13.39% from yesterday's closing price of 2.39 HKD, with a trading volume of 1.3686 million HKD. Today's highest price is 2.71 HKD, and the lowest price is 2.71 HKD. Based on yesterday's closing price, the 10-day average is 2.35 HKD, the 50-day average is 2.77 HKD, and the current PE is -162.59 times, with a 14-day relative strength index of 35.44.
Lepu Biotech-B (02157.HK) has entered into an exclusive licensing agreement for the innovative ADC MRG007.
On January 22, according to Gelonghui, Lepu Biopharma-B (02157.HK) announced that on January 22, 2025, the company entered into an exclusive licensing agreement with ArriVent Biopharma, Inc. (the company is listed on the Nasdaq Global Market (stock code: AVBP)) (“ArriVent”). According to this agreement, the company grants ArriVent exclusive rights to develop and commercialize the group's innovative antibody-drug conjugate ("ADC") MRG007 on a global basis, excluding the Greater China region. According to the licensing agreement, the company grants...
Express News | Lepu Biopharma - Deal With Arrivent Biopharma, Inc
Express News | Lepu Biopharma Co Ltd -Exclusive License Agreement for Novel ADC Mrg007
Express News | Arrivent Biopharma Enters Exclusive License With Lepu Biopharma for Mrg007, an Antibody Drug Conjugate for the Treatment of Gastrointestinal Cancers
Highly resilient! Leading CRO companies have stabilized their fundamentals, but the shadow of the biosafety bill may still linger next year | Year-end review.
① In 2024, the USA Biodefense Act will disrupt CROs throughout the year and may continue next year; ② In the first three quarters of this year, over half of listed companies experienced revenue growth, and leading CROs demonstrated resilience; ③ Research on popular targets such as ADC, GLP-1, and bispecific antibodies will continue to be hot; ④ In 2025, the performance of leading CROs and small to medium enterprises may further diverge.
【Brokerage Focus】The Pacific Securities initially rated Lepu Biopharma (02157) as "Buy", indicating that the ADC pipeline is about to enter a harvest period.
Jinwu Financial News | The Pacific Securities Research Reports indicate that Lepu Biopharma (02157) is focusing on precision matching for PD-1, creating a diverse and comprehensive combination of combination therapies: with a forward-looking layout around "PD-1 + ADC", the current EGFR ADC and HER2 ADC combined with PD-1 treatment schemes are in the phase II clinical stage; the clinical trials of oncolytic virus CG0070 combined with PD-1 for non-muscle invasive bladder cancer indications are in the preparation stage. The institution stated that Lepu Biopharma's Putri monoclonal antibody was commercialized in 2022 and is continuously expanding new indications through the combination with ADC.
The U.S. bioterrorism law has undergone significant changes, the CRO concept has launched a major counterattack, and WuXi AppTec is excited!
Industry pessimistic expectations may improve.
How to break through the challenges in the development of innovative drugs? The industry suggests focusing on internationalization.
① The year 2024 will be the inaugural year of large-scale authorized trade, and going abroad has become an important direction for the development of local pharmaceutical companies; ② Chinese企业品牌, clinical trial capabilities, data presentation formats, and levels of international operation still need time and practical verification.
Lepu Biopharma Co., Ltd.'s (HKG:2157) Largest Shareholder, Top Key Executive Zhongjie Pu Sees Holdings Value Fall by 9.6% Following Recent Drop
Lepu Biopharma Renews Procurement Contract With Controlling Shareholder