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Subjects: ERN, CCA

CStone Pharmaceuticals Reports Financial Results for the First Half of 2020


Suzhou, China, Aug. 18, 2020 /PRNewswire/ -- CStone Pharmaceuticals ("CStone"; HKEX: 2616), a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology (IO) therapies and precision medicines, today reported recent business highlights and financial results for the first half of 2020.

Dr. Frank Jiang, Chairman and Chief Executive Officer of CStone Pharmaceuticals, said, "We continued to make significant progress in our strategic transition to commercialization in the first half of 2020. We obtained one marketing approval from the regulator in Taiwan Region. In addition, we also filed two New Drug Applications (NDAs) in Chinese mainland and Taiwan Region respectively, and was granted priority review status in Chinese mainland. Furthermore, we have released highly promising data for our three core assets in their application for several key indications and have obtained several IND approvals.

Since the beginning of 2020, we've achieved three critical clinical and regulatory milestones, which propelling the company to near commercial stage:

These significant milestones further demonstrate our robust clinical development engine as we continue to accelerate our commercialization strategy.

As of today, we have completed the building of an industry-leading commercialization core team, successfully had our two precision therapies recommended for use according to the guidelines of Chinese Society of Clinical Oncology (CSCO) and launched our first drug in China through a commercial agreement in Bo'ao Hope City, Hainan. In the meantime, our Suzhou manufacturing site also started construction in the first half of the year. It is expected to provide strong manufacturing capabilities to bolster our commercialization initiatives and set a new benchmark for the industry.

The company is working on to accelerate the progress of nearly 30 clinical trials, including 15 registrational clinical studies and 11 clinical trials on combination therapies. In parallel, we continue to engage potential partners to discuss an array of value-creating opportunities, including in-licensing, out-licensing and strategic partnerships.

In terms of upcoming milestones in the second half of 2020, we look forward to one marketing approval and the submission of three NDAs. The two NDAs we plan on filing for NSCLC, together with ongoing pivotal trials for other products in our pipeline indicated for NSCLC, have prepared us with a powerful product portfolio for lung cancer, the largest cancer type presently found in China. The company will continue to strengthen product accessibility by leveraging synergies between our industry-leading commercial team and active external strategic collaborations, in turn better serving patients in need in China and across the globe, and further maximizing our overall commercial value."

Business Highlights

As of the date of this announcement, significant advancement has been made with respect to our product pipeline and business operations:

Late-stage Assets Progress

Early-stage Assets and Research Progress

Manufacturing Facility

Commercial Progress

Business Development

Financial Highlights

For the six months ended June 30, 2020, the research and development expenses and the administrative and selling expenses amounted to RMB470.4 million and RMB100.3 million respectively. While the loss excluding the effect of the fair value changes of the conversion feature of preferred shares and share-based payment expenses amounted to RMB508.5 million. As of June 30, 2020, our time deposits and cash and cash equivalents were RMB2,123.8 million.

Interim Results Presentation Information

The Company will host a live webcast for 2020 interim result presentation at 10am HKT, August 19, 2020, please find the access information as below.

If you are connecting outside Mainland China
Audience URL:
https://morganstanley.webcasts.com/starthere.jsp?ei=1353977&tp_key=0d201dc5a5

If you are connecting within Mainland China
Audience URL:
https://morganstanley.gmwebcasts.cn/starthere.jsp?ei=1353977&tp_key=0d201dc5a5  

About CStone Pharmaceutical

CStone Pharmaceuticals (HKEX: 2616) is a biopharmaceutical company focused on developing and commercializing 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 world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. The company has built an oncology-focused pipeline of 15 drug candidates with a strategic emphasis on immuno-oncology combination therapies. Currently, 5 late-stage candidates are at pivotal trials. With an experienced team, a rich pipeline, a robust clinical development-driven business model and substantial funding, CStone's vision is to become globally recognized as a leading Chinese biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide. For more information, please visit the www.cstonepharma.com

Forward-looking Statement 

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

 

SOURCE CStone Pharmaceuticals


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