China - CStone Pharmaceuticals ('CStone', HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, and Servier, a global independent pharmaceutical group, today announced an agreement whereby Servier acquires from CStone the exclusive rights to develop and commercialize TIBSOVO (ivosidenib tablets) in Greater China and Singapore.
Under the terms of the Agreement, CStone will transfer the TIBSOVO business, in the territories, to Servier for 44 million USD, followed by a payment of up to 6 million USD upon completion of the transition. As a result, the licensing agreement with Servier will be terminated and CStone will be released from payment obligations of any remaining development and commercialization milestones. In 2021, Servier acquired the oncology business of Agios Pharmaceuticals that had, since 2018, an exclusive collaboration and license agreement with CStone to develop and commercialize TIBSOVO in Greater China and Singapore.
'We have been working closely with Servier over the past two years, and actively advancing the development and commercialization of TIBSOVO in Asian regions, positioning it as the first IDH1 inhibitor in greater China territories. We are very proud of what CStone has accomplished and the significant efforts in the commercialization of this innovative medicine.' said Dr. Jason Yang, CEO of CStone, 'As the holder of its global rights, Servier is the ideal partner to further develop and commercialize TIBSOVO to maximize its value for patients in the Asian territories. This transaction will also enable us to focus on developing more first-in-class and best-in-class therapies for patients globally.'
'TIBSOVO marks a transformative breakthrough in cancer therapy for patients with an IDH1 mutation. Aligned with our global oncology strategy, this agreement empowers Servier to potentially deliver pioneering therapeutic options to patients with rare and challenging cancers in Greater China and Singapore' said, Philippe Gonnard, Executive Vice President, Global Product Strategy at Servier. 'This milestone underscores Servier's commitment to fortifying our oncology presence in Asia and our dedicated to oncology patients worldwide.'
In January 2022, the National Medical Products Administration (NMPA) of China approved TIBSOVO for the treatment of adult patients with relapsed/refractory acute myeloid leukemia (AML) who have a susceptible IDH1 mutation. Since its launch in mainland China, TIBSOVO is now accessible in close to 80 hospitals and DTP pharmacies and is covered by commercial insurance programs in about 100 cities. TIBSOVO has been included in over 6 clinical guidelines and consensus based on its strong clinical profile. Additionally, the Named Patient Program (NPP) for TIBSOVO has been launched in Hong Kong, Taiwan, and Singapore.
About TIBSOVO (ivosidenib tablets)
TIBSOVO is an oral targeted IDH1 inhibitor. The National Medical Products Administration of China has approved the NDA of TIBSOVO for the treatment of adult patients with relapsed/refractory acute myeloid leukemia who have a susceptible IDH1 mutation.
TIBSOVO is currently approved in the U.S. as monotherapy for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test, and as monotherapy or in combination with azacitidine for the treatment of adults with newly diagnosed AML with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adult patients who are 75 years old, or who have comorbidities that preclude use of intensive induction chemotherapy. TIBSOVO is also approved by the U.S. FDA as a monotherapy for the treatment of adult patients with previously treated locally advanced or metastatic cholangiocarcinoma with an IDH1-mutation as detected by an FDA-approved test. In 2023, TIBSOVO was approved by the U.S. FDA for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible IDH1 mutation as detected by an FDA-approved test.
TIBSOVO is also approved in Europe as a targeted therapy in two indications: in combination with azacitidine for the treatment of adult patients with newly diagnosed AML with an IDH1 R132 mutation who are not eligible to receive standard induction chemotherapy; as well as in monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.
Servier is the owner of TIBSOVO's rights globally.
About CStone
CStone (HKEX: 2616) is a biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established in 2015, CStone has assembled a management team with extensive experience in innovative drug development, clinical research, and commercialization. The company has built an oncology-focused pipeline of 14 drug candidates with a strategic emphasis on immuno-oncology combination therapies. Currently, CStone has received 13 NDA approvals for its four drugs. Multiple late-stage drug candidates are now under pivotal clinical trials or registration. CStone's vision is to bring innovative oncology therapies to cancer patients worldwide.
About Servier
Founded to serve health, Servier is a global pharmaceutical group governed by a Foundation that aspires to have a meaningful social impact, both for patients and for a sustainable world. With its unique governance model, it can fully serve its vocation with a long-term vision: being committed to therapeutic progress to serve patient needs. The 21,400 employees of the Group are committed to this shared vocation, a source of inspiration every day.
A world leader in cardiology, Servier's ambition is to become a focused and innovative player in oncology by targeting difficult and hard-to-treat cancers. That is why the Group allocates over 50% of its R&D budget to oncology.
Neuroscience and immuno-inflammatory diseases are future growth drivers. In these areas, Servier is focused on a limited number of diseases in which accurate patient profiling makes it possible to offer a targeted therapeutic response through precision medicine. To promote access to quality care for all at a lower cost, the Group also offers a range of quality generic drugs covering most pathologies, relying on strong brands in France, Eastern Europe, Brazil and Nigeria. In all these areas, the Group includes the patient voice at each stage of the life cycle of a medicine.
Headquartered in France, Servier has a strong geographical footprint with medicines distributed in over 150 countries and achieved a revenue of EUR4.9 billion in 2022.
Contact:
Email: presse@servier.com
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CSTONE PHARMACEUTICALS 
