Author:Qingfeng Pharmaceutical Group
Posted Time:2024-04-28 00:00
On the afternoon of April 28, 2024, Qingfeng Pharmaceutical Group's subsidiary, Kvvit Pharmaceuticals, signed a licensing agreement with Kexing Biopharm (688136.SH) for the international commercialization of Olaparib tablets. Qingfeng Pharmaceutical will grant Kexing Biopharm exclusive market rights for Olaparib tablets in the first 10 overseas markets. This collaboration marks another milestone in the company’s international expansion, following the approval of Enzalutamide Soft Capsules and its active pharmaceutical ingredient (API) by the U.S. FDA last year.
Olaparib tablets are a PARP (Poly ADP-Ribose Polymerase) inhibitor. The original drug was first approved by the U.S. FDA in 2014 for the treatment of advanced ovarian cancer in patients with BRCA mutations. Since then, its indications have expanded to include ovarian cancer, breast cancer, pancreatic cancer, prostate cancer, and other malignancies. It is recommended by the NCCN clinical guidelines as a first-line treatment for breast cancer and a first-line maintenance therapy for ovarian cancer.
In China, Olaparib tablets were first approved for marketing in 2018 for maintenance treatment in platinum-sensitive recurrent ovarian cancer patients. Subsequently, its indications in China have gradually expanded. In 2019, it was included in the National Basic Medical Insurance Drug List, becoming a key treatment option for many cancer patients. The Olaparib tablets currently under development by the company have entered the market approval stage in China and are expected to be approved in 2024.
Qingfeng Pharmaceutical has long been actively involved in oncology, with several drugs approved or under application, including Abiraterone, Sorafenib, Enzalutamide, Lenvatinib, Afatinib, Palbociclib, Regorafenib, and Olaparib.
As a new generation PARP inhibitor, Olaparib has a promising market outlook. In the first half of 2023, global sales of the original product reached 1.4 billion USD. The drug’s current clinical expansion includes not only the addition of new indications for monotherapy, but also exploring combination therapies, primarily with PD-L1 antibodies and Abiraterone Acetate. It is understood that the production of Olaparib tablets requires the use of advanced hot-melt extrusion technology, which is relatively rare in China. Qingfeng Pharmaceutical has taken the lead in adopting this approach for the domestic industry. Qingfeng Pharmaceutical has now established a leading high-tech manufacturing platform in China, including technologies such as microtablet compression, hot-melt extrusion, and osmotic pumps. High-end formulations like Esomeprazole Magnesium Enteric-Coated Tablets, Posaconazole Enteric-Coated Tablets, Doxazosin Sustained-Release Tablets, and Rabeprazole Sodium Enteric-Coated Tablets have all been approved and are being produced at scale.
This Collaboration Marks a Major Breakthrough in Qingfeng Pharmaceutical’s Global Expansion of High-End Formulations, Positively Impacting Overseas Markets and Bringing Significant Benefits to Patients Throughout the World
