CStone Pharmaceuticals Sells Exclusive Rights to Tibsovo® (Ivosidenib) in Greater China and Singapore to Servier

Suzhou and ParisDecember 21, 2023PR Newswire -- CStone Pharmaceuticals (HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative cancer immunotherapies and precision treatments, and Servier, a French pharmaceutical company, jointly announced today that they have reached an agreement. Under the agreement, CStone Pharmaceuticals will develop, manufacture, and commercialize TIBSOVO in Greater China (including mainland China, Hong Kong, Macau, and Taiwan) and Singapore.^®CStone Pharmaceuticals transfers the exclusive rights of (Ivosidenib Tablets) to Servier.

According to the terms of the agreement, CStone Pharmaceuticals will sell TIBSOVO at a transaction price of $44 million.^®The rights in the above regions are transferred to Servier, and an additional $6 million will be received upon completion of the transaction. Therefore, the licensing agreement between CStone Pharmaceuticals and Servier will be terminated, and CStone Pharmaceuticals will no longer be required to make subsequent R&D and commercial milestone payments. In 2021, Servier acquired Agios' oncology business. CStone Pharmaceuticals entered into an exclusive collaboration and licensing agreement with Agios in 2018, subsequently gaining access to TIBSOVO.^®Development and commercialization rights in Greater China and Singapore.

Dr. Jason Yang, CEO of CStone Pharmaceuticals, stated: "Over the past nearly three years, we have closely collaborated with Servier to develop and commercialize TIBSOVO in the Asian region.^®, making it the first IDH1 inhibitor in China and maximizing the drug's accessibility. CStone Pharmaceuticals has made tremendous efforts in commercializing the drug and established a solid market foundation in the authorized regions. We look forward to Servier, as the global rights holder of this product, further enhancing the accessibility of this innovative drug. Meanwhile, the benefits from this deal will help us focus on developing more first-in-class and best-in-class drugs with global rights, bringing more high-quality innovative therapies to patients worldwide."

Philippe Gonnard, Executive Vice President of Global Product Strategy at Servier, said: "Tibsovo^®It is a breakthrough therapy for treating cancer patients with IDH1 mutations. This agreement aligns closely with our global oncology development strategy and will drive Servier to provide innovative treatment options for patients with rare and refractory cancers in Greater China and Singapore. This milestone initiative demonstrates Servier's commitment to strengthening its oncology business in Asia and serving cancer patients worldwide.

In January 2022, the National Medical Products Administration of China approved Toshuwo.^®The new drug application for (Ivosidenib Tablets) is used to treat adult patients with relapsed or refractory acute myeloid leukemia (AML) carrying susceptible IDH1 mutations. Since its launch in mainland China, TIBSOVO^®Listed in more than 80 hospitals and DTP pharmacies, and included in approximately 100 city and commercial insurance programs. TIBSOVO^®Included in more than 6 national clinical diagnosis and treatment guidelines due to its clinical advantages. In addition, TIBSOVO^®Has also launched a Named Patient Program (NPP) in Hong Kong, China, Taiwan, China, and Singapore.

About TIBSOVO^®(Ivosidenib Tablets)

TIBSOVO^®Is an oral targeted inhibitor against the IDH1 mutant enzyme. TIBSOVO^®Has been approved by the China National Medical Products Administration for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) carrying IDH1 susceptible mutations.

TIBSOVO^®Approved in the United States for use as a single agent to treat patients with relapsed or refractory AML carrying susceptible IDH1 mutations as detected by an FDA-approved test, and for use as a single agent or in combination with azacitidine for newly diagnosed AML patients 75 years of age or older who carry susceptible IDH1 mutations as detected by an FDA-approved test, or for patients with comorbidities who are ineligible for intensive induction chemotherapy. TIBSOVO^®Approved for monotherapy in patients with previously treated cholangiocarcinoma harboring susceptible IDH1 mutations, as detected by an FDA-approved test. In 2023, TIBSOVO^®Approved by the U.S. FDA for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes (MDS) harboring susceptible IDH1 mutations as detected by an FDA-approved test.

TIBSOVO^®As a targeted therapy, it has been approved for two indications in Europe: TIBSOVO^®In combination with azacitidine for the treatment of newly diagnosed AML adult patients with IDH1 R132 mutations who are not suitable for standard induction chemotherapy; TIBSOVO^®Adult patients with locally advanced or metastatic cholangiocarcinoma harboring an IDH1 R132 mutation who have received at least one prior systemic therapy before single-agent treatment.

About CStone Pharmaceuticals

CStone Pharmaceuticals (HKEX Code：2616) is a biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology and precision treatments to address the significant unmet medical needs of cancer patients in China and globally. Established at the end of 2015, CStone Pharmaceuticals has assembled a management team with extensive experience in new drug discovery, clinical research, and commercial operations. With a core focus on combination therapies in immuno-oncology, the company has built a robust pipeline comprising 14 oncology drug candidates. To date, CStone Pharmaceuticals has received approval for 13 new drug applications for four innovative medicines. Several late-stage drug candidates are currently in pivotal clinical trials or registration stages. CStone Pharmaceuticals aspires to become a globally renowned biopharmaceutical company, leading the way in the fight against cancer.

For more information about CStone Pharmaceuticals, please visit:www.cstonepharma.com。

About Servier

Servier is an international pharmaceutical group managed by a foundation, with the mission of serving human health and aspiring to bring profound social impact for patients and the sustainable development of the world. With its unique management model, Servier fully commits to its long-term mission with a forward-looking vision: advancing progress in therapeutic fields and addressing patients' needs. The group’s 21,400 employees are dedicated to this shared mission, which is the driving force behind all our actions.

As a global leader in the field of cardiology, Servier will next target refractory cancers and become a focused and innovative contributor in the field of oncology. To this end, the group allocates more than 50% of its R&D budget to the field of oncology.

Neuroscience and immune inflammation are the driving forces behind the Group's sustained growth. In these fields, Servier will focus on a few diseases, enabling targeted treatment responses through precision medicine by means of precise patient analysis. To promote high-quality medical services at a lower cost for all, the Group leverages the influence of its strong brand clusters in France, Eastern Europe, Brazil, and Nigeria to offer a range of high-quality generic drugs covering most conditions. In all these areas, the Group places the patient's voice at every stage of the drug lifecycle.

Servier, headquartered in France, operates in more than 150 countries and regions worldwide, achieving revenue of 4.9 billion euros in 2022.

For more information, please visit servier.com

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