Abbisko Therapeutics Achieves Major Milestone for Pimicotinib
Abbisko Therapeutics Makes Progress with Pimicotinib
Abbisko Therapeutics Co., Ltd. (02256.HK) has announced that the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for pimicotinib. This indicates a significant step in providing treatment for Tenosynovial Giant Cell Tumor (TGCT), a condition that can severely affect the daily lives of those who experience it. Pimicotinib is a unique, small-molecule inhibitor of CSF-1R and represents an important advancement in cancer therapy for adult patients.
The Importance of Pimicotinib in TGCT Treatment
Professor Niu Xiaohui, Director of the Bone and Soft Tissue Tumor Diagnosis and Research Centre, highlights the severe impact TGCT has on young to middle-aged adults. The symptoms, including swelling, pain, and stiffness around joints, can hinder the ability to perform daily functions effectively, diminishing both work and social lives. The data from the recent MANEUVER study showcases pimicotinib's potential to shift the treatment landscape for TGCT patients.
Accelerating Review Process
The acceptance of the NDA was further bolstered by the designation of Priority Review granted to pimicotinib by the NMPA’s Center for Drug Evaluation (CDE). This expedited review process showcases the urgency and potential of this medication for patients needing systemic treatment, considering the challenges TGCT poses. Also, pimicotinib has received Breakthrough Therapy Designation (BTD) from the NMPA, reinforcing its promise.
Collaboration with Merck
In a strategic move, Abbisko entered an agreement with Merck for global commercialization rights for pimicotinib. Yao-Chang Xu, Chairman and CEO of Abbisko Therapeutics, acknowledges that NDA acceptance is pivotal for the company’s journey and affirms their commitment to innovation within drug development. Meanwhile, Hong Chow, Head of Healthcare business of Merck in China and internationally, emphasizes the aim of providing the first approved systemic therapy for TGCT in China, addressing a considerable need.
Clinical Study Successes
The NDA submission is founded on the encouraging results from Part 1 of the global Phase 3 MANEUVER study. Here, pimicotinib showcased a statistically significant enhancement in the primary endpoint of the objective response rate (ORR) compared to a placebo after 25 weeks (54.0% vs. 3.2%, p<0.0001). Moreover, it also displayed significant improvements in other patient-reported outcomes, indicating enhanced mobility, reduced stiffness, and less pain.
Global Designation and Market Perspectives
In addition to its recognition by the NMPA, pimicotinib has also received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) and PRIME Designation from the European Medicines Agency (EMA). This global attention underlines the drug's exceptional potential and opens avenues for expanded treatment options for patients.
About Abbisko Therapeutics
Founded in April 2016, Abbisko Therapeutics Co., Ltd. (HKEX: 02256.HK) is a biopharmaceutical company focused on oncology. With its base in Shanghai, the company is dedicated to developing innovative medicines for unmet medical needs, both in China and worldwide. Founded by a team of experienced drug developers with rich backgrounds in multinational pharmaceutical companies, Abbisko has built a robust pipeline focused on precision and immuno-oncology.
Frequently Asked Questions
What is pimicotinib?
Pimicotinib is a small-molecule CSF-1R inhibitor developed by Abbisko Therapeutics aimed at treating Tenosynovial Giant Cell Tumor (TGCT).
What company is behind pimicotinib?
Abbisko Therapeutics Co., Ltd. is the biotechnology firm developing pimicotinib.
What was achieved with the NMPA's acceptance?
The acceptance of the New Drug Application for pimicotinib marks a significant milestone in providing treatment options for TGCT patients in China.
What has been said regarding the clinical trials?
Clinical trials have shown significant improvements in treatment outcomes, including reductions in pain and increased mobility for patients suffering from TGCT.
What future plans does Abbisko have for pimicotinib?
Abbisko and Merck plan to engage in further commercial activities, with potential applications to other markets, including the US and Europe.
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