| Subject |
National Health Security Administration of China has not included Fespixon Cream in this year NRDL adjustment negotiation after the expert review. |
- Date of occurrence of the event: 2024/09/14
- Company name: ONENESS BIOTECH CO., LTD.
- Relationship to the Company (please enter ”head office” or ”subsidiaries”): head office
- Reciprocal shareholding ratios: NA
- Cause of occurrence:
- (1) For the adjustment on 2024 National Reimbursement Drug List in China, Oneness, Microbio (Shanghai) and the China partner have filed application for Fespixon (Xiangleitangzugao) but it has not been included in this year’s negotiation for NRDL adjustment after the expert review.
- (2) Fespixon has been out-licensed to the China partner in July and launched in August this year. The written package to support expert review can be reinforced and the application will be filed in 2025 with the partner after a more in-depth brand awareness building.
- Countermeasures:
- (1) Microbio (Shanghai) and the China partner will proceed as planned to market Fespixon (Xiangleitangzugao) in the self-paid market in China.
- (2) The requirements and regulations for ”natural drug” and ”traditional Chinese medicine” in China are completely different but currently, the National Health Security Administration does not have a specific expert group to review ”natural drugs”. Therefore, it is temporarily reviewed by experts of traditional Chinese medicine. To meet the requirements of NRDL application, Oneness will collect more comprehensive post-market data and analysis on Fespixon (Xiangleitangzugao) to strengthen its benefits and pharmacoeconomic advantages in Chinese patients. A new application will be filed next year.
- Any other matters that need to be specified(the information disclosure also meets the requirements of Article 7, subparagraph 9 of the Securities and Exchange Act Enforcement Rules, which brings forth a significant impact on shareholders rights or the price of the securities on public companies.): None.
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