ChemRar Group Launches Early-Access Program for the Innovative Breast Cancer Therapy Bireociclib in Russia
Russia’s first access program for the drug will provide treatment to 80 patients from the country’s leading oncology centers.
ChemRar Group and Xuanzhu Biopharmaceutical Co., Ltd. announced a scientific collaboration and the launch in Russia of an expanded (early) access program for bireociclib (Chinese approved name; proposed trade name in Russia, pending registration: Cyclinza™), a therapy intended for patients with hormone receptor-positive (HR+), HER2-negative advanced breast cancer.
Bireociclib is an oral, small-molecule agent developed by Xuanzhu Biopharmaceutical Co., Ltd. that inhibits several cyclin-dependent kinases simultaneously — CDK2, CDK4, CDK6 and CDK9 (a CDK2/4/6/9 inhibitor). Its key distinction from other CDK4/6 inhibitors — abemaciclib, ribociclib and palbociclib — lies in its multi-target activity: beyond CDK4 and CDK6, it can also overcome tumor resistance associated with increased CDK2 activity. In response to CDK4/6 blockade, cancer cells upregulate CDK2, enabling them to bypass standard-therapy blockade and restore cell-cycle progression. By inhibiting CDK2 in addition to CDK4/6, bireociclib suppresses this escape mechanism.
The drug’s efficacy and safety have been demonstrated in clinical trials, on the basis of which it was approved in China (NMPA) in May 2025 for three indications: first-line therapy in combination with aromatase inhibitors, second-line therapy in combination with fulvestrant, and third-line and beyond monotherapy.
About the Early-Access Program
The program’s objective is to provide Russian patients with innovative therapy before the drug completes state registration in Russia. This mechanism is governed by Federal Law No. 323-FZ of November 21, 2011, «On the Fundamentals of Protecting the Health of Citizens in the Russian Federation.» A total of 80 patients will take part in the program, selected across three treatment indications:
- First line + hormone therapy: bireociclib in combination with an aromatase inhibitor (letrozole or anastrozole) as first-line therapy for HR+/HER2- advanced or metastatic breast cancer, in patients with contraindications to approved therapy.
- Second line + endocrine therapy: bireociclib in combination with fulvestrant in patients progressing during or after endocrine therapy, in patients with contraindications to approved therapy.
- Third line and beyond — monotherapy: bireociclib monotherapy following ≥2 lines of endocrine therapy and/or chemotherapy at the metastatic stage, when no other therapeutic options are available.
The decision to use an unregistered drug is made by a medical board (physician council) of the specific healthcare institution, based on documented clinical justification.
Participating Medical Centers
The program involves leading Russian federal and regional oncology centers that are authorized to conduct federal medical boards and have the relevant patient base.
Quotes
|
«ChemRar Group is consistently pursuing a strategy of bringing the world’s best developments into Russian healthcare, where cooperation with Chinese partners is taking on strategic importance. This is not simply a way to compensate for the shortage of Western innovations, which have not been introduced to our market since 2022. This model allows us to rapidly select, adapt and implement the most promising global developments into Russian clinical practice — shortening the path from a scientific idea to a specific patient and strengthening our pharmaceutical capabilities. The launch of the early-access program for bireociclib is an important step toward ensuring that Russian patients with advanced breast cancer begin receiving one of oncology’s most promising innovations today, without waiting for marketing authorization, which in Russia takes an average of 2–3 years.» — Kravchenko D.V., President, ChemRar Group |
|
«The launch of the early-access program for bireociclib is truly an important step for Russian oncology. This drug, with its unique multi-target mechanism (CDK2/4/6/9), opens new possibilities for patients with hormone-receptor-positive, HER2-negative breast cancer, particularly those resistant to standard endocrine therapy. The ability to begin treatment early, without waiting for final registration, is a real opportunity for our patients, who have a limited choice of effective options. It is critically important that the drug is becoming available right now.» — Prof. Orlova R.V., MD, PhD, DSc, Honored Doctor of the Russian Federation, Chief Specialist in Clinical Oncology and Rehabilitation of the City Clinical Oncology Dispensary, St. Petersburg |
|
«For Xuanzhu Biopharmaceutical Co., Ltd., launching the bireociclib early-access program in Russia is an important step in fulfilling our mission: to make our innovative therapies part of international clinical practice. Bireociclib, a multi-target CDK2/4/6/9 inhibitor, has already demonstrated efficacy in patients with hormone-receptor-positive, HER2-negative advanced breast cancer and has a marketing authorization in China. We are glad that Russian oncologists and their patients will now have the opportunity to begin treatment with this targeted therapy. As a partner, it is especially important to us that it will be provided on preferential terms. This approach reflects our commitment to the principle of making modern therapy accessible to those who need it.» — Deyan Hou, Senior Director of Business Development, Xuanzhu Biopharmaceutical Co., Ltd. |
About the Companies
About ChemRar Group
ChemRar Group is a leading Russian association of research, manufacturing and investment companies in innovative pharmaceuticals. ChemRar Group covers the full drug development cycle — from molecule synthesis through preclinical and clinical research to market launch.
About Xuanzhu Biopharmaceutical Co., Ltd.
Xuanzhu Biopharmaceutical Co., Ltd. (HKEX: 2575) is the innovative biopharmaceutical arm of Sihuan Pharmaceutical Holdings Group Ltd. (HKEX: 0460), specializing in the development of original oncology therapeutics. The company is the developer and rights holder of bireociclib (Xuanyuening, XZP-3287).
Media Contacts
ChemRar Group: es@chemrar.ru | Tel.: +7 (495) 925-30-74
Xuanzhu Biopharmaceutical: ir@sihuanpharm.com | Tel.: +852 3628 3911