Hainan Shuangcheng Pharmaceuticals Co. Ltd (the “company”) received the notification from the U.S. FDA that the ANDA (abbreviated new drug application) of Paclitaxel (Albumin bound) for injection s
2025-11-18 10:25
Hainan Shuangcheng Pharmaceuticals Co. Ltd (the “company”) received the notification from the U.S. FDA that the ANDA (abbreviated new drug application) of Paclitaxel (Albumin bound) for injection submitted has been approved.
Hainan Shuangcheng Pharmaceuticals Co. Ltd (the “company”) received the notification from the U.S. FDA that the ANDA (abbreviated new drug application) of Paclitaxel (Albumin bound) for injection submitted has been approved.
Product detail
The name of the drug: Paclitaxel (Albumin bound) for injection
ANDA application No. : 216355
Dosage form: Sterile injection
Strength: 100 mg/vial
Applicant holder: Hainan Shuangcheng Pharmaceuticals Co. Ltd
Manufacturer: Ningbo Shuangcheng Pharmaceuticals Ltd
Indication: Paclitaxel (Albumin bound) for injection is used as microtubule inhibitor to treat:
Breast cancer that has spread to other parts of the body and has not improved or worsened after treatment with other medications or Breast cancer that recurs within 6 months of adjuvant chemotherapy. Unless there are clinical contraindications, neoadjuvant treatment should include anthracyclines.
Paclitaxel is also used in combination with carboplatin as first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC).
Paclitaxel in combination with gemcitabine is used as first-line treatment for metastatic pancreatic adenocarcinoma.
Paclitaxel (Albumin-bound) for Injection is classified as a high-difficulty and complex pharmaceutical preparation. Due to the high review requirements of the U.S. FDA for this type of product and the strict GMP production management standards, it is difficult to obtain FDA approval.
The company's Abbreviated New Drug Application (ANDA) for Paclitaxel (Albumin-bound) for Injection has been approved by the U.S. FDA for marketing. This approval indicates that the safety and efficacy of the company's Paclitaxel for Injection (Albumin-bound) have reached the level of the original innovator drug, demonstrating the internationally advanced R&D and production capabilities of Shuangcheng Pharmaceutical. Meanwhile, it enriches the company's product pipeline for international sales, further advances the process of the company's international layout, and has an important positive impact on enhancing the international influence of the company's products and the company's future operating performance.
The approval of this Paclitaxel (Albumin-bound) for Injection means the drug has obtained legal sales qualification in the United States. The company has received multiple order applications from distributors and completed the first export shipment to the United States. This will help enhance the market competitiveness of the company's products, provide a new profit growth point for the company, and facilitate the healthy, long-term and stable development of the company.
