Core Viewpoint - Recently, China Resources Double Crane (华润双鹤) announced that its subsidiary, Hunan Xiangzhong Pharmaceutical Co., Ltd., received the drug registration certificate for Oxcarbazepine tablets from the National Medical Products Administration (NMPA), which is expected to enhance the company's product line and market competitiveness [1][2]. Group 1: Drug Registration and Market Potential - The Oxcarbazepine tablets are indicated for the treatment of primary generalized tonic-clonic seizures and partial seizures in adults and children aged 5 and above [1]. - The research and development of this generic drug began in August 2021, with the application for market approval submitted in July 2024 and the approval expected in November 2025 [1]. - The global sales of Oxcarbazepine tablets are projected to reach $351 million in 2024, with the brand "Trileptal" accounting for $162 million of that total [1]. Group 2: Competitive Landscape - In the Chinese market, there are 10 approved manufacturers of Oxcarbazepine tablets, with 9 having passed or deemed to have passed the consistency evaluation [2]. - The total sales of Oxcarbazepine tablets in the domestic medical and retail markets are estimated at 738 million yuan in 2024, with Novartis holding a market share of 74.17%, followed by Beijing Four Ring Pharmaceutical at 13.78% and Wuhan Renfu Pharmaceutical at 11.85% [2]. Group 3: Company Overview and Financial Performance - China Resources Double Crane operates 24 subsidiaries and employs 13,000 staff, focusing on new drug research and development, formulation production, drug sales, and active pharmaceutical ingredient production [2]. - The company reported a third-quarter revenue of 2.542 billion yuan, a year-on-year decrease of 2.96%, while net profit increased by 6.71% to 374 million yuan [3]. - For the first three quarters of 2025, the total revenue was 8.283 billion yuan, down 3.1% year-on-year, with net profit declining by 3.4% to 1.35 billion yuan [3]. Group 4: Recent Drug Approvals - Recently, the company has received multiple drug registration certificates for its subsidiaries, including Bosentan dispersible tablets for pulmonary arterial hypertension and a new injection for acute coronary syndrome [4].
华润双鹤控股子公司获得奥卡西平片药品注册证书 进一步丰富公司产品线