CStone Pharmaceuticals

CStone Pharmaceuticals (基石药业) is an innovative, research-driven biopharmaceutical company founded in late 2015 and headquartered in Suzhou, Jiangsu, China. It is listed on the Hong Kong Stock Exchange under the stock code 2616.HK. The company focuses on discovering, developing and commercializing drugs in oncology, immuno-oncology and inflammation-related diseases, aiming to address unmet medical needs of cancer patients in China and globally. According to its corporate profile, CStone has successfully launched four innovative drugs, obtained approval for 21 New Drug Applications (NDAs) and nine indications. Its current pipeline is balanced across antibody-drug conjugates (ADCs), monoclonal and multi-specific antibodies, immuno-oncology agents and precision medicines, with 13 innovative drug candidates in development. The company describes its pipeline as one of the larger oncology-focused pipelines in China. CStone's commercialized precision oncology products include GAVRETO® (pralsetinib, marketed in China as 普吉华®), a selective RET inhibitor and China's first domestically approved selective RET inhibitor, and AYVAKIT® (avapritinib, marketed in China as 泰吉华®), a kinase inhibitor approved for PDGFRA exon 18 mutant gastrointestinal stromal tumors (GIST). Its immuno-oncology portfolio includes sugemalimab (择捷美®), an anti-PD-L1 monoclonal antibody developed for multiple cancer indications including non-small cell lung cancer, esophageal squamous cell carcinoma and gastric/gastroesophageal junction adenocarcinoma, as well as nofazinlimab, an anti-PD-1 antibody. The company operates a translational medicine research center in Suzhou built to international clinical trial standards, and maintains a management team covering the full chain from preclinical discovery and clinical translation to clinical development, drug manufacturing, business development and commercial operations. CStone has pursued partnerships and out-licensing arrangements in China and the Asia-Pacific region, including collaborations with companies such as 3SBio and Arrotex in Australia. CStone's stated vision is to "pioneer a new era of medicine and build the cornerstone of health" (拓新药时代 筑健康基石). It continues to advance next-generation candidates such as CS5007 (an EGFR/HER3 bispecific ADC) and CS2009 (a PD-1/VEGF/CTLA-4 trispecific antibody), reflecting its strategy of building an innovative pipeline 2.0 with global development ambitions.

CStone Pharmaceuticals was founded in late 2015 as an innovative, research-driven biopharmaceutical company. It is headquartered in Suzhou, Jiangsu, China, and is listed on the Hong Kong Stock Exchange under the stock code 2616.HK. The company set out to address unmet medical needs in oncology and immuno-oncology in China and globally, and has since built one of the larger oncology-focused pipelines in China. In January 2022, CStone achieved a significant milestone with the approval in China of 拓舒沃® (ivosidenib tablets), the first IDH1 inhibitor in China, providing a new treatment option for patients with acute myeloid leukemia. In the same month, the company announced that the GEMSTONE-302 study of 择捷美® (sugemalimab injection) for first-line treatment of metastatic non-small cell lung cancer met its overall survival endpoint, and that the registrational clinical study of sugemalimab for relapsed/refractory lymphoma met its primary endpoint. Research on sugemalimab was also published in The Lancet Oncology. In March 2022, 普吉华® (pralsetinib capsules) was approved in China for the treatment of advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer. Pralsetinib also received regulatory progress in the United States, Europe, Hong Kong and Taiwan under the brand name GAVRETO®. In the same month, 拓舒沃® (ivosidenib tablets) made multiple significant advances in the United States and Europe, and pralsetinib's NDA for RET fusion-positive NSCLC was accepted in Hong Kong. In 2023, CStone continued to expand its portfolio and global reach. In January 2023, the company announced that the registrational clinical study of 择捷美® (sugemalimab injection) for first-line treatment of esophageal squamous cell carcinoma met its primary endpoint, and that 普吉华® (pralsetinib) was approved in Taiwan for advanced RET fusion-positive NSCLC and RET-altered thyroid cancer. In February 2023, the European Medicines Agency accepted the marketing authorization application for sugemalimab for metastatic squamous and non-squamous NSCLC, and the NDA for sugemalimab as first-line treatment of locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma was accepted by China's NMPA. In March 2023, research on sugemalimab monotherapy for extranodal NK/T-cell lymphoma was published in the Journal of Clinical Oncology. In April 2023, the NDA for sugemalimab as first-line treatment of esophageal squamous cell carcinoma was accepted by China's NMPA. In June 2023, the expanded indication of 普吉华® (pralsetinib capsules) for first-line treatment of RET fusion-positive NSCLC was approved by China's NMPA. In October 2023, a new indication for 择捷美® (sugemalimab injection) for relapsed/refractory extranodal NK/T-cell lymphoma was approved in China. In November 2023, CStone entered a strategic cooperation and exclusive licensing agreement with 3SBio for nofazinlimab (an anti-PD-1 monoclonal antibody) in mainland China. By its corporate profile, CStone has successfully launched four innovative drugs, obtained approval for 21 NDAs and nine indications, and its current pipeline includes 13 innovative drug candidates spanning ADCs, monoclonal/multi-specific antibodies, immuno-oncology agents and precision medicines. The company operates a translational medicine research center in Suzhou built to international clinical trial standards and maintains a management team covering the full chain from preclinical discovery to commercial operations. It has pursued partnerships and out-licensing in China and the Asia-Pacific region, including with Arrotex in Australia for sugemalimab. In 2026, CStone was included in Stock Connect effective September 7, and reported interim results highlighting the acceleration of its innovative pipeline 2.0, including CS5007 (an EGFR/HER3 bispecific ADC) and CS2009 (a PD-1/VEGF/CTLA-4 trispecific antibody).

• 2026

  CStone included in Stock Connect, effective September 7.

• 2026

  CS5007 (EGFR/HER3 bispecific ADC) IND application approved by China NMPA after global Phase I trial initiation in Australia.

• 2023

  择捷美® (sugemalimab) registrational study met primary endpoint in first-line esophageal squamous cell carcinoma.

• 2023

  European Medicines Agency accepted marketing authorization application for sugemalimab in metastatic NSCLC.

• 2023

  普吉华® (pralsetinib) expanded indication for first-line RET fusion-positive NSCLC approved in China.

• 2023

  CStone and 3SBio signed strategic cooperation and exclusive licensing agreement for nofazinlimab in mainland China.

• 2022

  拓舒沃® (ivosidenib tablets), China's first IDH1 inhibitor, approved in China for acute myeloid leukemia.

• 2022

  GEMSTONE-302 study of 择捷美® (sugemalimab) met overall survival endpoint in first-line metastatic NSCLC.

• 2022

  普吉华® (pralsetinib capsules) approved in China for RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer.

• 2015

  CStone Pharmaceuticals founded in late 2015.

• 普吉华® (pralsetinib capsules)

  China's first selective RET inhibitor, approved as a Class 1 new drug by China NMPA for RET fusion-positive locally advanced or metastatic NSCLC, RET-mutant medullary thyroid cancer, and RET fusion-positive thyroid cancer. Marketed as GAVRETO® in the US, EU and Hong Kong.

• 泰吉华® (avapritinib tablets)

  China's first approved treatment for PDGFRA exon 18 mutant gastrointestinal stromal tumors (GIST). A kinase inhibitor for adults with unresectable or metastatic GIST harboring PDGFRA exon 18 mutations. Marketed as AYVAKIT® in the US and Hong Kong, AYVAKYT® in the EU, and 泰時维® in Taiwan.

• 择捷美® (sugemalimab injection)

  An anti-PD-L1 monoclonal antibody developed for multiple cancer indications including non-small cell lung cancer, esophageal squamous cell carcinoma, gastric/gastroesophageal junction adenocarcinoma, and extranodal NK/T-cell lymphoma.

• 拓舒沃® (ivosidenib tablets)

  China's first IDH1 inhibitor, approved in China for acute myeloid leukemia and also落地博鳌 for cholangiocarcinoma patients.

• nofazinlimab (anti-PD-1 monoclonal antibody)

  An anti-PD-1 monoclonal antibody; CStone signed a strategic cooperation and exclusive licensing agreement with 3SBio for mainland China in November 2023.

• CS5007 (EGFR/HER3 bispecific ADC)

  An EGFR/HER3 bispecific antibody-drug conjugate; IND application approved by China NMPA after global Phase I trial initiation in Australia.

• CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody)

  A PD-1/VEGF/CTLA-4 trispecific antibody; two oral presentations selected at ESMO 2026.

• 2022

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• 2021-04-27

  Yuanshin Technology Group and CStone Pharmaceuticals enter strategic cooperation[7]圆心科技集团与基石药业达成战略合作finance.sina.com.cn

  Reported: 2021-04-28

  Yuanshin Technology Group and CStone Pharmaceuticals held a strategic cooperation signing ceremony in Shanghai and announced cooperation to explore internet healthcare services and medical insurance-related areas, including payment solutions for innovative medicines.

• 2020-10-11

  CStone completes approximately $200 million share subscription by Pfizer affiliate[8]基石药业完成辉瑞关联方约2亿美元认购股份prnewswire.com

  Reported: 2020-10-12

  CStone announced that a Pfizer affiliate completed a subscription for newly issued CStone shares worth approximately US$200 million, representing about 9.90% of CStone's enlarged issued share capital.

• 2020-03-26

  CStone Pharmaceuticals releases 2019 annual financial results[9]基石药业发布2019年度财务业绩prnewswire.com

  Reported: 2020-03-26

  CStone Pharmaceuticals released its audited annual financial results for the year ended December 31, 2019.

• 2019-09-30

  CStone presents CS1001 Phase Ib study results at ESMO[10]基石药业于ESMO发布CS1001 Ib期研究资料finance.sina.com.cn

  Reported: 2019-09-30

  CStone presented a poster at the 2019 European Society for Medical Oncology annual meeting with safety summary data from the Phase Ib GEMSTONE-101 study of its investigational anti-PD-L1 antibody CS1001; the results showed overall safety and tolerability were good.

1. 1CStone Pharmaceuticals (China) - Wikidatawikidata.org
2. 2基石药业官网首页cstonepharma.com
3. 3发展历程-基石药业cstonepharma.com
4. 4公司概况-基石药业cstonepharma.com
5. 5精准治疗药物-基石药业cstonepharma.com
6. 6理财浮亏5千多万、高管离任引争议thepaper.cn
7. 7圆心科技集团与基石药业达成战略合作finance.sina.com.cn
8. 8基石药业完成辉瑞关联方约2亿美元认购股份prnewswire.com
9. 9基石药业发布2019年度财务业绩prnewswire.com
10. 10基石药业于ESMO发布CS1001 Ib期研究资料finance.sina.com.cn
11. 11CStone Pharmaceuticals Reports Financial Results for the First Half of 2020prnewswire.com