Group 1 - The company’s subsidiary, Hengtai Wanyang Pharmaceutical, received approval for the chemical raw material drug Dapagliflozin, indicating compliance with national drug registration requirements [1] - Dapagliflozin is a selective SGLT-2 inhibitor used for treating type 2 diabetes by promoting glucose excretion [2] - China has over 118 million diabetes patients, accounting for 22% of the global burden, with the diabetes medication market projected to reach 52.7 billion yuan in 2024, where Dapagliflozin holds a 12.83% market share [3] Group 2 - The market for Dapagliflozin is expected to grow to 7.38 billion yuan in 2025, with a sales volume of 1.78 billion tablets, reflecting a year-on-year growth of 35% and 38% respectively [3] - Dapagliflozin has been included in the national centralized procurement directory, with a price reduction of over 90%, benefiting more patients [3] - The company plans to leverage this domestic approval to accelerate international registration and sales of Dapagliflozin, targeting markets in Europe and the US [3] Group 3 - The company’s subsidiary, Yiling Wanzhou International Pharmaceutical, received approval for the drug Valaciclovir, enhancing the company’s product pipeline [7] - Valaciclovir is an antiviral drug used for treating herpes zoster and simplex virus infections, with a market share of 3.17% in the antiviral drug market projected to reach 4.5 billion yuan in 2025 [9][10] - The increasing incidence of herpes zoster, especially among the aging population, is expected to drive demand for Valaciclovir [10] Group 4 - The company has submitted a clinical trial application for a new traditional Chinese medicine, Qilong Dingchuan Tablets, which has been accepted by the National Medical Products Administration [13] - The proposed indications for Qilong Dingchuan Tablets include treating chronic obstructive pulmonary disease with symptoms such as shortness of breath and cough [16]
石家庄以岭药业股份有限公司 关于全资孙公司收到化学原料药上市申请批准通知书的公告