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The National Medical Products Administration is seeking opinions: Inclusion of a 30-day channel application for the review and approval of clinical trials for innovative drugs.
The National Medical Products Administration's Comprehensive Department is publicly soliciting opinions on the "Notice on Optimizing the Review and Approval of Clinical Trials for Innovative Drugs (Draft for Comments)". Among them, it is proposed that applications included in the 30-day channel for the review and approval of innovative drug clinical trials should be innovative drugs classified as class 1 Traditional Chinese medicine, chemical drugs, and Biologics, capable of submitting the required application materials, and must meet one of the following conditions: key innovative drugs supported by the state. Key innovative drug varieties with significant clinical value supported by the national full-chain support policy for innovative drug development; selected for the National Medical Products Administration's Children's Drug Starlight Program or Rare Disease Care Program.
REMEGEN (09995) Shareholders will transfer Stocks from Hong Kong Stock Connect (Shanghai) to BNP Paribas, with a Market Cap of 0.373 billion Hong Kong dollars.
On June 16, REMEGEN (09995) Shareholders transferred Stocks from Hong Kong Stock Connect (Shanghai) to BNP Paribas, with a transfer Market Cap of 0.373 billion Hong Kong dollars, accounting for 3.34%.
"Big Banks" UBS Group downgraded REMEGEN (09995.HK) rating to "Neutral" and raised the Target Price to 63.8 yuan.
The UBS Group research report indicates that REMEGEN (09995.HK) has tripled in stock price since the beginning of the year, surpassing the 64% increase in the Industry, mainly due to the progress of its pipeline products, and the fundraising of 0.796 billion yuan has also alleviated the group's tight financial situation. The firm believes that from a 12-month perspective, the group's stock price is reasonable, as recent major positive catalysts have been reflected in the stock price, downgrading the rating from the original 'Buy' to 'Neutral'. Additionally, considering the global sales and estimated expenses of RC18, the Target Price has been significantly raised from 33.7 yuan to 63.8 yuan.
China Securities Co.,Ltd.: In the second half of the year, the A-share market is expected to gradually shift upward in its volatile center, poised for potential growth. Focus on innovative drugs and other areas.
China Securities Co., Ltd. released a research report stating that in the second half of 2025, driven by the trend of a weak dollar, supportive policies in the Capital Markets, and an overall improvement in the liquidity environment, the A-share market's fluctuation center is expected to gradually rise, gathering momentum for a takeoff.
UBS Downgrades RemeGen Co. Ltd. Class H (9995) to a Hold
REMEGEN (688331.SH): The company's core drug patent has received a term extension.
On June 13, Glonhui reported that REMEGEN (688331.SH) announced that the company received the "Approval Decision on Patent Term Compensation for Pharmaceutical Patents" issued by the National Intellectual Property Administration. The name of the patent is: optimized TACI-Fc fusion protein, involving the drug: injectable Tisotumab vedotin. According to the relevant provisions of China's Patent Law and its implementation rules, it has been decided to grant patent term compensation for this patented drug, with a compensation period of 1,827 days. The original expiration date of the patent was June 15, 2027, and the new expiration date is June 15, 2032. During the patent term compensation period, its protection scope is limited to the State Council's drug monitoring.
