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復星醫藥：海外監管公告 - 關於控股子公司獲藥品註冊申請受理的公告

FOSUN PHARMA: Overseas Regulatory Announcement - Announcement in Relation to the Acceptance of a Subsidiary's Drug Registration Application

HKEX ·  Dec 3 18:02

Summary by Moomoo AI

2024年12月3日，复星医药宣布其控股子公司河北万邦复临药业有限公司的中药3.1类新药桃红四物颗粒的药品注册申请已获国家药品监督管理局受理。该新药主要用于治疗血虚血瘀证，症状包括月经不调、血多有块等。至2024年10月，复星医药在该新药的研发上累计投入约372万元人民币。\\n该新药的处方来源于清代柴得华的《妇科冰鉴》桃红四物汤，并已列入国家中医药管理局的古代经典名方目录。尽管药品注册申请已获受理，但在商业化生产前仍需通过GMP符合性检查及获得药品注册批准。复星医药表示，此次受理不会对集团现阶段业绩产生重大影响。\\n复星医药提醒投资者，由于医药产品的行业特点，药品上市后的销售情况可能受到用药需求、市场竞争及销售渠道等因素影响，具有较大不确定性。投资者需注意相关风险。
2024年12月3日，复星医药宣布其控股子公司河北万邦复临药业有限公司的中药3.1类新药桃红四物颗粒的药品注册申请已获国家药品监督管理局受理。该新药主要用于治疗血虚血瘀证，症状包括月经不调、血多有块等。至2024年10月，复星医药在该新药的研发上累计投入约372万元人民币。\\n该新药的处方来源于清代柴得华的《妇科冰鉴》桃红四物汤，并已列入国家中医药管理局的古代经典名方目录。尽管药品注册申请已获受理，但在商业化生产前仍需通过GMP符合性检查及获得药品注册批准。复星医药表示，此次受理不会对集团现阶段业绩产生重大影响。\\n复星医药提醒投资者，由于医药产品的行业特点，药品上市后的销售情况可能受到用药需求、市场竞争及销售渠道等因素影响，具有较大不确定性。投资者需注意相关风险。
On December 3, 2024, Fosun Pharma announced that its subsidiary, hebei Wanbang Fulin Pharmaceutical Co., Ltd., has had the drug registration application for the traditional Chinese medicine class 3.1 new drug Taohong Siwu Granules accepted by the National Medical Products Administration. This new drug is primarily used to treat symptoms of blood deficiency and blood stasis, including irregular menstruation and excessive menstrual bleeding with clots. As of October 2024, Fosun Pharma has invested approximately 3.72 million RMB in the development of this new drug. The prescription for this new drug is derived from the Taohong Siwu Decoction in the "Gynecological Ice Mirror" by Chai Dehua from the Qing Dynasty and has been included in the catalogue of ancient classic formulas by the National Administration of...Show More
On December 3, 2024, Fosun Pharma announced that its subsidiary, hebei Wanbang Fulin Pharmaceutical Co., Ltd., has had the drug registration application for the traditional Chinese medicine class 3.1 new drug Taohong Siwu Granules accepted by the National Medical Products Administration. This new drug is primarily used to treat symptoms of blood deficiency and blood stasis, including irregular menstruation and excessive menstrual bleeding with clots. As of October 2024, Fosun Pharma has invested approximately 3.72 million RMB in the development of this new drug. The prescription for this new drug is derived from the Taohong Siwu Decoction in the "Gynecological Ice Mirror" by Chai Dehua from the Qing Dynasty and has been included in the catalogue of ancient classic formulas by the National Administration of Traditional Chinese Medicine. Although the drug registration application has been accepted, commercial production still requires passing GMP compliance checks and obtaining drug registration approval. Fosun Pharma stated that this acceptance will not have a significant impact on the group's current performance. Fosun Pharma reminds investors that due to the characteristics of the pharmaceutical industry, the sales situation of drugs after listing may be affected by factors such as medication demand, market competition, and sales channels, which carry a high degree of uncertainty. Investors should be aware of the associated risks.

This announcement is a separate document:

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