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基石药业-B(02616.HK):泰吉华(阿伐替尼片)100mg规格由境外转移至境内生产的药品上市注册申请已获国家药监局批准

The pharmaceutical company Cornerstone Pharmaceuticals-B (02616.HK) has received approval from the National Medical Products Administration for the registration of the listing of the drug Taijihua (Afatinib Tablets) 100mg, which was transferred from overs

Gelonghui Finance ·  Aug 14 20:03

On August 15th, Stone Pharmaceutical-B (02616.HK) announced that Taijihua (Apatinib Tablets) with 100mg specifications, which have been transferred to domestic production, have been approved for market registration applications by the National Medical Products Administration of China (NMPA). Following the approval of Taijihua 300mg specification in June 2024, the approval of the 100mg specification further enriches Taijihua's flexibility in medication selection. Both specifications are expected to gradually replace existing imported products by the end of 2024 or early 2025, achieving domestic supply.

Dr. Yang Jianxin, CEO, Chief R&D Officer, and Executive Director of Stone Pharmaceutical, said: "The approval of Taijihua 100mg and 300mg specifications for market registration of domestically produced drugs can not only better meet the needs of different patients and provide convenience for patients, but also greatly improve Taijihua's accessibility and market competitiveness in China. Our another precision treatment product, Pujihua (Pralatinib Capsules), which has been transferred to domestic production, has been accepted for market registration applications in April this year and is currently under review by the NMPA Drug Evaluation Center. We will continue to be committed to providing high-quality drugs for Chinese patients through advanced manufacturing technology, strict production and quality control."

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