CStone Pharmaceuticals Announces 2018 Annual Financial Results

Shanghai, China; March 22, 2019 -- CStone Pharmaceuticals (“CStone”; HKEX: 2616), a leading clinical-stage biopharmaceutical company focused on developing and commercializing innovative immuno-oncology therapies for the treatment of cancer, today released its audited annual financial results for the year ended December 31, 2018.

“2018 was a milestone year for CStone Pharmaceuticals, which led to our successful listing on the Hong Kong Stock Exchange on February 26, 2019 with a satisfactory trading performance since listing.” said Dr. Frank Jiang, Chairman and CEO of CStone.In 2018, we obtained 2 IND approvals from the U.S. FDA, and initiated 6 Phase I studies and 4 Phase II/III pivotal studies, including our first Phase II and Phase III pivotal studies. Our core drug candidate, a leading domestically developed fully human PD-L1 antibody CS1001, is currently being investigated in two Phase III studies for NSCLC. In June 2018, we obtained exclusive licenses from Agios and Blueprint for the development and commercialization of four molecularly targeted compounds in Greater China, all of which have proof of concept for their lead indications based on clinical data from their U.S. trials and are currently being prepared for clinical development in China. Among the four compounds, two are the first in their respective class globally and two have the potential to be first-in-class globally.”

“Looking into 2019, we will continue to advance our five pre-clinical assets towards the IND stage and identify new drug candidates to complement our current pipeline. We plan to enhance the commercial potential of our four late-stage clinical drug candidates with worldwide or Greater China rights by adding more pivotal clinical trials in 2019. We will continue to grow our commercial team and evaluate options for partnership to maximize market potential of our assets both in China and globally.” said Dr. Frank Jiang.

FINANCIAL HIGHLIGHTS

• Other income increased by RMB18.1 million from RMB14.0 million for the year ended December 31, 2017 to RMB32.1 million for the year ended December 31, 2018.


• Other gains and losses increased by RMB649.9 million from losses of RMB103.7 million for the year ended December 31, 2017 to losses of RMB753.6 million for the year ended December 31, 2018. The increase in other losses was primarily attributable to the increase in company valuation caused by the possibility of an initial public offering.


• Research and development expenses increased by RMB636.8 million from RMB213.4 million for the year ended December 31, 2017 to RMB850.2 million for the year ended December 31, 2018.


• Administrative expenses increased by RMB151.7 million from RMB39.3 million for the year ended December 31, 2017 to RMB191.0 million for the year ended December 31, 2018.


• As a result of the above factors, the loss for the year increased by RMB1,450.6 million from RMB342.5 million for the year ended December 31, 2017 to RMB1,793.1 million for the year ended December 31, 2018.

BUSINESS HIGHLIGHTS

On February 26, 2019 (the “Listing Date”), the Company was successfully listed on The Stock Exchange of Hong Kong Limited (the “Stock Exchange”). As disclosed in the Prospectus, we have made significant progress with respect to our product pipeline:

• We have built a robust pipeline of 14 oncology drug candidates, including three IO backbone drug candidates at clinical stage, to maximize our opportunities to develop IO combination therapies.


• Our core product candidate, CS1001, is an investigational monoclonal antibody directed against PD-L1 that is currently being investigated in pivotal clinical trials in China. We have initiated a first-in-human Phase I study since October 2017 to evaluate the safety, tolerability, PK and anti-tumor activity of CS1001 in patients with advanced tumors in China. The Phase Ia (dose escalation) portion was completed in May 2018, and the Phase Ib (dose expansion) portion has also been initiated. We have initiated two pivotal Phase II trials of CS1001 as a monotherapy for the treatment of cHL and NKTL and two Phase III clinical trials of CS1001 as a monotherapy for the treatment of Stage III NSCLC and in combination with standard-of-care therapies for Stage IV NSCLC. We are strategically developing CS1001 for cHL and NKTL, both of which are in pivotal Phase II trials. If the data from these trials are positive, we expect to make the NDA submission for cHL in the first half of 2020.


• Our pipeline is complemented by four molecularly targeted compounds in order to address significant unmet patient needs. In June 2018, we obtained exclusive licenses from Agios and Blueprint for the development and commercialization of four molecularly targeted compounds in Greater China, all of which have proof of concept for their lead indications based on clinical data from the U.S. trials and are currently being prepared for clinical development in China. Ivosidenib is the first treatment for IDH1m relapsed or refractory AML in its class globally. Avapritinib (CS3007) is also the first drug candidate in its class globally, and CS3008 (FGFR4 inhibitor) and CS3009 (RET inhibitor) each has the potential to be first-in-class globally.


• We focus on clinical development because we believe it has long been a bottleneck in China's new drug development value chain. We employ adaptive and biomarker-guided clinical design to achieve efficiency and accelerate clinical development. Our clinical development capabilities have been proven by internally advancing four drug candidates into the clinical stage at an industry-leading speed. Since our inception, we have submitted twenty IND/CTA applications for nine drug candidates and obtained thirteen IND/CTA approvals for eight drug candidates, including two from the U.S. FDA for CS1001 (PD-L1 antibody) and CS1003 (PD-1 antibody) and three from TGA for CS1002 (CTLA-4 antibody), CS1003 (PD-1 antibody) and CS3006 (MEK inhibitor).

FUTURE AND OUTLOOK

• We plan to maximize the commercial potential of our four late-stage clinical drug candidates with worldwide or Greater China rights. We plan to add multiple pivotal clinical trials for our late stage drug candidates by the end of 2019, to continue to advance them to commercialization in China.


• We have recently assembled our core commercial leadership team. We will continue to expand in anticipation of our expected product launches in the next several years. We are also evaluating options for commercial partnership to accelerate commercial ramp up and maximize market potential of our assets both in China and globally.


• Leveraging our strong internal research capabilities, we continue to identify and develop new drug candidates to advance to clinical stage. We will continue to advance our five pre-clinical assets towards the IND stage and develop new internal assets through our in-house research capability and collaboration with top academic institutions and world-leading CROs.


• China's oncology drug market has grown rapidly in recent years. According to Frost & Sullivan, revenue of the oncology drugs in China is expected to further grow to RMB262.1 billion in 2022. The difference between the global market and the China market suggests significant potential for molecularly targeted drug and immuno-oncology drug market growth in China. With the vision to become globally recognized as a leading Chinese biopharmaceutical company by bringing innovative and differentiated oncology therapies to cancer patients worldwide, Cstone is dedicated to developing and commercializing innovative immuno-oncology and molecularly targeted drugs to address significant unmet medical needs in cancer treatment.

ABOUT CSTONE PHARMACEUTICALS

CStone Pharmaceuticals (HKEX:2616) is a biopharmaceutical company focused on developing and commercializing innovative immuno-oncology and precision medicine 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 with a strategic emphasis on immune-oncology combination therapies. Currently, 4 late-stage candidates are at or near 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 about CStone Pharmaceuticals, please visit: 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.

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