On May 29th, the NMPA website announced the formal market approval of Genor Biopharma’s highly selective oral CDK4/6 inhibitor, Lerociclib Hydrochloride Tablets. It is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (HR+/HER2-) locally advanced or metastatic breast cancer:
· In combination with fulvestrant for patients whose disease has progressed after prior endocrine therapy.
FAB, as China’s leading medical imaging CRO, provided comprehensive Independent Review Committee (IRC) services for the Phase III clinical study of this drug.
Source: NMPA
Lerociclib is a differentiated oral CDK4/6 inhibitor. Its innovative molecular structure, target specificity and potency, and unique pharmacokinetic/pharmacodynamic (PK/PD) profile enable continuous oral dosing without requiring treatment breaks. This achieves sustained target inhibition and superior anti-tumor efficacy while exhibiting a distinctive and favorable safety profile. Lerociclib has demonstrated outstanding efficacy in multiple registration clinical studies (including superior efficacy in refractory populations with advanced breast cancer, such as those with primary endocrine resistance and visceral metastases), along with its differentiated and improved safety and tolerability profile. It significantly reduces common CDK4/6 inhibitor-associated adverse events, such as severe myelosuppression and diarrhea, fully validating Lerociclib's differentiated advantages for patients with advanced breast cancer.
Source: Genor Biopharma
The collaboration on this project began in 2020, with FAB deeply involved in the central imaging review for the drug's Phase III clinical study. Facing enrollment pressure, FAB prioritized efficient execution, rigorously ensuring enrollment quality from an imaging perspective. This included providing baseline image quality eligibility assessments and imaging-related inclusion/exclusion criteria compliance evaluations to ensure enrolled cases met the protocol requirements. Ultimately, 275 subjects were successfully enrolled.
During clinical trial operations, FAB actively participated in designing the image acquisition protocol, developing the independent review charter, customizing the review system, and training on assessment standards at investigator meetings. Given the specificities of breast cancer diagnosis and assessment, FAB provided professional medical imaging consultation services throughout the study. The FAB project team collaborated closely with all stakeholders to promptly address and resolve various issues encountered during image quality control and transfer, demonstrating profound expertise, comprehensive operational experience, and a high level of dedication. To meet the stringent timelines for image review, the project team proactively tackled challenges, efficiently coordinated expert schedules, and ensured high-quality reviews were completed on time. The efficient synergy and deep rapport displayed by both teams throughout the collaboration earned high praise from the Sponsor.
During the NMPA inspection, Aminy Tian, Clinical Operations Director of FAB, traveled to two inspection sites. With exceptional professionalism, she adeptly addressed the inspectors' inquiries, communicated with and guided investigators on imaging-related questions, resulting in no imaging-related findings. Her outstanding performance garnered commendation and a letter of appreciation from the Sponsor!
Notably, this marks the seventh innovative drug project in the breast cancer field successfully supported to market by FAB. To date, the cumulative number of innovative drug approvals supported by FAB has reached 41, representing fruitful achievements.
FAB extends its heartfelt congratulations to Genor Biopharma on this significant milestone achievement! We look forward to continuing our partnership, scaling new heights together in future collaborations, and bringing benefits to patients worldwide!
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