SIHUAN PHARM (00460) saw an increase of more than 5% before the midday break. As of the time of writing, the stock had risen by 5.19% to HK$1.42, with a turnover of HK$19.4691 million. On March 3, the company announced that its non-wholly owned subsidiary, Xuanzhu Biotech, had received approval from the National Medical Products Administration (NMPA) for a new supplemental new drug application (sNDA) for its self-developed innovative drug, Palociclib Tablets (brand name: Xuan Yue Ning®). The approval covers its use in combination with an aromatase inhibitor (AI) as a first-line treatment for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. This marks the third approved indication for Palociclib in China, following earlier approvals for use in combination with fulvestrant and as a monotherapy. With this latest approval, Palociclib has become the first and only drug of its kind in China to cover the entire treatment course—first-line, second-line, and later-line therapy—for HR+/HER2- advanced breast cancer. The expansion of Palociclib's indications to include first-line treatment for HR+/HER2- advanced breast cancer significantly broadens the patient population it can serve, enhances the drug’s clinical value and accessibility, and provides strong support for future sales growth.
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