SHANGHAI, March 30, 2020 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced its audited consolidated annual results of the Company and its subsidiaries for the full-year ended December 31, 2019.
Financial Highlights (IFRS):
- Total revenue was RMB775 million, mainly due to the sales of toripalimab since its commercialization in February 2019.
- Due to continued investment in research and development (“R&D”), our R&D expenses were RMB946 million, representing a 75.8% increase from that in 2018. With constant progress in key clinical trials and the introduction of co-R&D and license-in projects, the Company’s R&D pipeline expanded to small molecule drugs and antibody drug conjugates.
- Selling and distribution expenses were RMB320 million, mainly due to the launch and commercialization of toripalimab.
- Total comprehensive expense was RMB741 million, representing a slight increase from RMB715 million in 2018, mainly benefits from the contribution of toripalimab sales, but offset by the increase in R&D expenses and administrative expenses.
- Net cash from financing activities was RMB594 million, principally attributable to net cash from the exercise of over-allotment option of H shares amounting RMB404 million in our initial public offering of H shares on The Stock Exchange of Hong Kong Limited.
- Net cash used in investing activities was RMB952 million, mainly due to (1) the Lingang Production Base’s construction. The Lingang Production Base is expected to enhance our current production capacity by ten times; and (2) diversification of our R&D pipeline and expansion to small molecule drugs and ADCs through equity investment.
We have achieved significant progress with respect to our product commercialization, clinical trials, pipeline expansion and construction of production bases in the year of 2019, including:
- As of the date of this announcement, we have developed a product pipeline comprising 21 drug candidates which covers a wide variety of disease areas associated with high levels of unmet medical needs, using our core platforms and through collaborations with third parties;
- As of the date of this announcement, there were 14 pivotal registered clinical trials covering a broad spectrum indications for toripalimab being conducted simultaneously, including: urothelial carcinoma (“UC”), nasopharyngeal carcinoma (“NPC”), melanoma, non-small cell lung carcinoma (“NSCLC”), small cell lung carcinoma (“SCLC”), triple-negative breast carcinoma (“TNBC”), esophageal carcinoma (“EC”), hepatocellular carcinoma (“HCC”), gastric carcinoma (“GC”) and renal cell carcinoma (“RCC”);
- Toripalimab has been well recognized in academic research during the year. Relevant study results have been published in journals such as Monoclonal Antibodies (mAbs), Journal of Hematology & Oncology, Annals of Oncology and Journal of Clinical Oncology (JCO). In addition to the outstanding publication track-record in top academic journals, toripalimab related research was also presented in a series of influential academic conferences such as American Society of Clinical Oncology (“ASCO”), European Society for Medical Oncology (“ESMO”), World Conference for Lung Cancer (“WCLC”) and Chinese Society of Clinical Oncology (“CSCO”). With the clinically-proven safety and efficacy, toripalimab is recommended in the 2019 edition of the CSCO Guidelines for the Diagnosis and Treatment of Melanoma;
- TAB004/JS004 (anti-BTLA monoclonal antibody) Investigational New Drug (“IND”) was approved for clinical study by the US FDA. We are currently conducting Phase I clinical trial in the United States. TAB004/JS004 was also approved for clinical trial by the National Medical Products Administration of China (“NMPA”) on January 23, 2020;
- NDA application for UBP1211 (Humira biosimilar) to NMPA was submitted, and it was accepted in November 2019;
- JS005 (anti-IL-17A monoclonal antibody) has received the Clinical Trial Approval from NMPA in August 2019. Phase I clinical trial of JS005 is expected to complete the first patient enrollment in the first half of 2020; and
- Our Lingang Production Base with 30,000L capacity in Shanghai, constructed in accordance with the Current Good Manufacturing Practice (cGMP) standards, has obtained the Drug Production License issued by the Shanghai Medical Products Administration.
At present, we have 21 drug candidates, including 13 original innovative drugs independently developed by the Company and 8 drugs jointly developed with our partners. Our diversified drug pipeline covers different R&D stages. Our first product, JS001 (i.e. toripalimab), was officially launched for sale with approved indication of locally advanced or metastatic melanoma after standard treatment failure. Nine candidates obtained IND approvals from NMPA, including:
- JS001, which was conditionally approved for marketing, commenced clinical trials for indication expansion;
- UBP1211 (a biosimilar of Humira) was accepted for New Drug Application (“NDA”) by NMPA;
- JS002 (a recombinant humanized anti-PCSK9 monoclonal antibody for injection) commenced Phase II clinical trial;
- JS501 (a biosimilar of Avastin);
- JS003 (a recombinant humanized anti-PD-L1 monoclonal antibody for injection);
- JS101 (a pan-CDK inhibitor);
- TAB004/JS004 (a recombinant humanized anti-BTLA monoclonal antibody for injection);
- JS005 (a recombinant humanized anti-IL-17A monoclonal antibody for injection) commenced Phase I clinical trial; and
- UBP1213 (a recombinant humanized anti-BLyS monoclonal antibody for injection) is being prepared for clinical trial.
Two candidates obtained approval from the US FDA for clinical trial:
- JS001 commenced Phase Ib clinical trial in the United States.
- TAB004/JS004 is the world’s first anti-BTLA monoclonal antibody for cancer treatment approved for clinical trial, and commenced Phase I clinical trial in the United States.
Twelve candidates are in the preclinical research stage, and an IND application for JS108 (a recombinant humanized anti-Trop2 monoclonal antibody-Tub196 conjugate for injection) has been submitted to the NMPA.
About Junshi Biosciences
Established in 2012, Junshi Biosciences is committed to developing first-in-class and best-in-class drugs through original innovation and becoming a pioneer in the area of translational medicine to provide patients with effective and affordable treatment options. On December 24, 2018, Junshi Biosciences was listed on the Main Board of the Stock Exchange of Hong Kong with the stock code: 1877.HK. The Company has established a diversified R&D pipeline comprising 21 drug candidates with therapeutic areas covering cancer, metabolic diseases, autoimmune diseases, and neurologic diseases. Product types include monoclonal antibodies, fusion proteins, antibody drug conjugates, and small molecule drugs. With a combined 33,000L fermentation capacity in two GMP facilities at Shanghai and Wujiang, Junshi has established the manufacturing infrastructure to support commercialization and provide our partners and patients with high-quality products through a global supply chain network. For more information, please visit: http://junshipharma.com/en/
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