By adopting Pinnacle 21® Enterprise (P21E), Abbisko Therapeutics accelerated its path to pimicotinib approval, completing its NMPA submission and securing Bijieermai FDA NDA acceptance from the FDA.

服务

Biostatistics & Statistical Programming

解决方案

Preclinical, Early Clinical

Products

Pinnacle 21 Enterprise, Pinnacle 21 Data Validation and Submission Readiness

Abbisko Therapeutics Co., Ltd. is a biopharmaceutical company dedicated to the research, discovery, and development of innovative and differentiated medicines that address unmet medical needs of patients in China and around the world. Focused on small molecule drugs, Abbisko has built deep expertise in targeted tumor therapy and tumor immunotherapy, with a growing pipeline spanning early discovery through regulatory submission.

Pimicotinib (marketed in China as Bijieermai®) is a new oral CSF-1R inhibitor discovered and developed by Abbisko. The drug is used to treat tenosynovial giant cell tumor (TGCT), a rare and often debilitating tumor of the joints and tendons. Pimicotinib is licensed to Merck KGaA, Darmstadt, Germany for worldwide commercialization.

We spoke with Hailan Feng, Statistical Programming Director at Abbisko Therapeutics, about the company’s experience adopting Pinnacle 21® Enterprise (P21E) to strengthen its clinical data compliance and regulatory review processes when seeking pimicotinib FDA approval.

Key factors in gaining pimicotinib approval

As Abbisko worked toward pimicotinib approval, its clinical pipeline grew, and the statistical programming team needed a way to raise the bar on regulatory readiness across every study. The team’s priorities were to:

Achieve end-to-end compliance control and a comprehensive upgrade of data quality
Proactively identify and manage submission risks to improve project success rates
Reduce cost and improve efficiency to:
- accelerate R&D
- speed products to market
Strengthen full lifecycle data management to build long-term industry competitiveness

Achieving regulatory compliance with Pinnacle 21 Enterprise

Since May 2024, Abbisko has deployed Pinnacle 21 Enterprise to optimize and streamline its internal regulatory review system, building on a long-term, stable collaboration with Certara and Tri-I Biotech.

The platform has helped the team validate data quality and comply with CDISC standards, establishing itself as a high-quality, efficient channel for submitting data to regulatory authorities – including its NMPA submission for pimicotinib.

“P21E fully empowers clinical data compliance management and the entire regulatory submission process, providing strong support for the efficient advancement and regulatory compliance of our R&D projects,” said Hailan Feng, Statistical Programming Director, Abbisko Therapeutics.

Their implementation of Enterprise was a smooth process, backed by professional training and responsive support from the P21E Certara team. Feng added:

“The training was very professional, and the communication and feedback were also very timely.”

How Pinnacle 21 Enterprise facilitated Pimicotinib approval and FDA NDA acceptance

With Pinnacle 21 Enterprise embedded in its clinical programming workflow, Abbisko has achieved a comprehensive upgrade across its clinical R&D data management and submission processes. This support has helped the team achieve pimicotinib approval through both pimicotinib NMPA approval and pimicotinib FDA approval, culminating in Bijieermai FDA NDA acceptance.

The platform also helped Abbisko support its multinational partner in completing pimicotinib’s global out-licensing, and continues to help the company accelerate the launch of new products.

Key impacts:

Successful pimicotinib NMPA approval (also known as pimicotinib China approval) and Bijieermai FDA NDA acceptance
Supported global out-licensing to its multinational pharmaceutical partner
Comprehensive upgrade in clinical R&D data management and submission processes
A single, standardized channel for regulatory submissions, validated for data quality and CDISC compliance
Faster, more confident regulatory reviews, helping accelerate the launch of new products

“After implementing the Pinnacle 21 Enterprise platform, Abbisko Therapeutics achieved a comprehensive upgrade in its clinical R&D data management and submission processes,” Feng said.

Next steps

Are you ready to strengthen your regulatory submissions like Abbisko Therapeutics? Abbisko’s pimicotinib drug approval is one example of how Pinnacle 21 Enterprise supports mission-critical regulatory submissions, from NMPA submission through FDA review. Learn how your organization can achieve similar results with Pinnacle 21 Enterprise

Pinnacle 21 是一家软件领域的全球领先公司，其软件的作用是准备临床试验数据以进行监管申报。全球最大的 25 家生物制药公司中有 22 家信任 Pinnacle 21 Enterprise。It is the same validation platform used by the US FDA and Japan’s PMDA to review a submission’s data quality, CDISC compliance, and fitness for use.

Certara continues to help more life science innovators accelerate their modern drug development in China.

Are you ready to transform your validation of clinical data management like Abbisko?

To discover how your organization can achieve similar results, learn more about Pinnacle 21 Enterprise.

了解更多信息

Book a demo of Pinnacle 21

常见问题解答

What is pimicotinib approval?

Pimicotinib approval refers to regulatory clearance for pimicotinib, an oral CSF-1R inhibitor for adult patients with symptomatic tenosynovial giant cell tumor (TGCT).

What does Bijieermai FDA NDA acceptance mean for the pimicotinib FDA approval process?

Bijieermai FDA NDA acceptance means the FDA has confirmed pimicotinib’s New Drug Application is complete enough for formal review. This is an important step toward full pimicotinib FDA approval. Acceptance is not the same as approval; the FDA will now conduct a substantive review of clinical and manufacturing data before reaching a decision.

What is the difference between pimicotinib NMPA approval (pimicotinib China approval) and pimicotinib FDA approval?

Pimicotinib NMPA approval, also known as pimicotinib China approval, was granted in December 2025 for adult TGCT patients in China. Pimicotinib FDA approval is a separate process still underway in the U.S., following FDA acceptance of the NDA. Each regulator applies its own review timelines and data standards.

Why is CDISC compliance important for an NMPA submission?

CDISC standards ensure clinical trial data is structured consistently, making it easier for regulators to review and validate submitted datasets during an NMPA submission. Non-compliant data can trigger delays or added queries, so validating compliance early supports a smoother regulatory pathway across markets.

How long does pimicotinib approval typically take after FDA NDA acceptance?

Standard FDA review is about 10 months from acceptance, while Priority Review can shorten timelines to around 6 months. Breakthrough Therapy Designation, which pimicotinib has received, does not guarantee a faster review but can accelerate the overall pimicotinib approval timeline.

Securing Pimicotinib Approval: How Abbisko Therapeutics Successfully Completed its NMPA and FDA Submissions with Pinnacle 21 Enterprise