KELUN PHARMA(SZ:002422) Ge Long Hui·2025-10-21 04:06Core Insights - The approval of the new drug injection trastuzumab botidotin by Kelun Pharmaceutical marks a significant milestone in the company's product portfolio, targeting HER2-positive breast cancer patients who have previously undergone treatment [1][3] - Kelun Pharmaceutical's launch of the rotigotine patch represents the first domestic generic version of a drug that has dominated the Parkinson's disease treatment market, breaking the original manufacturer's monopoly [6][9] - The company has demonstrated a strong performance in the pharmaceutical sector, with over 40 generic drugs approved this year, enhancing its competitiveness in both domestic and international markets [11] Drug Approvals - The injection trastuzumab botidotin is a HER2 ADC monoclonal antibody developed by Kelun Biotech, approved for patients with unresectable or metastatic HER2-positive breast cancer who have received prior HER2-targeted therapies [3] - The rotigotine patch, originally developed by UCB Pharma, is the first transdermal patch for treating Parkinson's disease, with global sales exceeding $300 million in 2023, accounting for approximately 22% of the market share for Parkinson's treatments [6][9] Market Position - Kelun Pharmaceutical has successfully launched two ADC drugs, trastuzumab botidotin and another drug, enhancing its position in the ADC market, which is a key focus area for the company [4] - The approval of the rotigotine patch not only diversifies Kelun's product offerings but also positions the company as a significant player in the Parkinson's disease treatment market, previously dominated by UCB Pharma [6][9] Clinical Development - Kelun has a robust pipeline with nine ADC drugs in various stages of clinical trials, indicating a strong commitment to innovation and development in the oncology sector [4] - The company has also received approvals for additional new drugs, including injection formulations that further expand its therapeutic range [11]