— Supplemental NDAs for Toripalimab filed
— Expanding into infectious disease and collaborating with IMCAS and Lilly for COVID-19 neutralizing antibodies
— Dual Listing on the STAR Market
Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced its financial results for the six months ended June 30, 2020 and provided corporate updates.
First Half 2020 Financial Highlights
– Total revenues reached RMB575 million in the first half year of 2020, representing an 86% increase compared with the first half year of 2019. Sales of Toripalimab was RMB426 million, out of which RMB254 million was generated in the second quarter, representing recovery from the initial outbreak of COVID-19 in early 2020. Gross margin increased slightly to approximately 90% due to capacity utilization and productivity improvement. Sub-licensing and service income was RMB149 million. Junshi entered into a research collaboration and license agreement with Lilly and granted Lilly a license to conduct research, development and commercialization of JS016, an innovative drug for the treatment and prevention of COVID-19 in May 2020.
– The research and development (“R&D”) expenses were RMB709 million in the first half year of 2020, representing an increase of 92% compared to RMB369 million for the same period in 2019. The increase was primarily due to progress of key clinical trials, more R&D collaboration and license-in activities expanding our pipelines to small molecule drugs, antibody drug conjugates (ADCs) and JS016.
– The property, plant and equipment (“PPE”) by the end of June 2020 increased 11% to RMB2,026 million compared with the end of year 2019. The significant growth of the PPE was primarily due to the construction of the Lingang Production Base, which will enhance our current production capacity by ten folds.
– Total comprehensive expense for the Reporting Period was RMB593 million, representing an increase of 105% compared to first half of 2019, mainly due to profit generated from Toripalimab sales, service income and sub-licensing income but offset by the increase in R&D expenses and administrative and selling expenses.
– As of 30 June 2020, our bank and cash balances decreased to RMB676 million from RMB1,214 million as of 31 December 2019. The decrease was mainly due to: 1) investment in ongoing R&D projects, new R&D collaboration and license-in projects; 2) investment in and acquisition of companies in the pharmaceutical sector; and 3) investment in the production bases especially the Lingang Production Base. Subsequently, in July 2020, the company completed a public offering of A shares on the STAR Market of the Shanghai Stock Exchange and received gross proceeds of approximately RMB483.6 million.
Business Highlights
During the Reporting Period, we achieved significant progress with respect to our product commercialization, clinical trials and pipeline expansion. The Company’s products concentrated on self-developed biological products with original innovation. At the same time, through co-development and technology transfer/license-in, we further expanded our product pipeline. As of the end of the Reporting Period, we had 21 drug candidates, including 19 innovative drugs and 2 biosimilars, covering five major therapeutic areas including malignant tumors, autoimmune diseases, chronic metabolic diseases, neurologic diseases and infectious diseases.
– During the Reporting Period, 15 pivotal registered clinical trials for Toripalimab were being conducted, in which 2 pivotal registered clinical trials were applied for NDA to the National Medical Products Administration (“NMPA”) and included in the process of priority review, covering a broad spectrum of indications, including: melanoma, urothelial carcinoma, nasopharyngeal carcinoma, non-small cell lung carcinoma, esophageal carcinoma, small cell lung carcinoma, triple negative breast carcinoma, hepatocellular carcinoma, gastric carcinoma and renal cell carcinoma.
— In March 2020, Toripalimab in combination with Axitinib for treatment of mucosal melanoma was granted the orphan-drug designation by the US Food and Drug Administration (“FDA”).
— In April and May 2020, the supplemental NDAs in respect of Toripalimab as a treatment for recurrent/metastatic NPC after failure of second-line and above systemic treatment and for locally advanced or metastatic urothelial carcinoma who received previous treatment were accepted by the NMPA, marking a new stage in the layout of indications in the segmented areas of Toripalimab. The two supplemental NDAs had been included in the process of priority review by the NMPA in July 2020.
— In June 2020, the Company and Merck KGaA entered into clinical trial collaboration in respect of the use of Toripalimab in combination with Cetuximab (Erbitux) for the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck.
– The Company’s drug candidate TAB004/JS004 (a recombinant humanized anti-BTLA monoclonal antibody for injection) was approved for clinical trials in China by the NMPA, and the first patient was dosed in a Phase I clinical study in April 2020. In addition, its Phase I clinical study in the United States has completed dose-escalation study and entered dose-expansion stage.
– The first subject was dosed in a Phase I clinical study of JS005 (a recombinant humanized anti-IL-17A monoclonal antibody for injection) in China in May 2020. At present, the Phase I clinical study has completed random enrollment.
– In March 2020, the Company and the Institute of Microbiology, Chinese Academy of Sciences (“IMCAS”) entered into a project cooperation agreement to jointly develop and produce novel coronavirus neutralizing antibody JS016 (a recombinant fully human anti-SARS-CoV-2 monoclonal antibody for injection), an innovative drug for the treatment and prevention of COVID-19.
— In May 2020, the Company and Lilly entered into an agreement to collaborate on research, develop and commercialize potential preventive and therapeutic antibody therapies for COVID-19, and Lilly was granted an exclusive license to conduct research, develop and commercialize JS016 outside Greater China.
— In May 2020, the international authoritative journal “Nature” published the results of JS016 pre-clinical research, which reported for the first time that the neutralizing antibody of SARS-CoV-2 can significantly inhibit novel coronavirus infection in the test on non-human primate rhesus monkeys, showing the dual effect of treatment and prevention.
— In June 2020, JS016 was approved to conduct Phase I clinical trial in China, and the enrollment of subjects in the Phase I clinical trial was completed in July 2020. The international multi-center clinical trial was a randomized, double-blind and placebo controlled Phase I clinical study, aiming at evaluating the tolerability and safety of single-dose intravenous infusion of JS016 in healthy subjects. We plan to recruit 40 healthy subjects (including both male and female) as the world’s first novel coronavirus neutralizing antibody clinical trial conducted in healthy subjects. We are conducting Phase Ib international multi-center clinical studies for patients with mild/normal novel coronavirus pneumonia. And we expect to commence Phase II/III clinical study for patients with severe and critical novel coronavirus pneumonia as soon as possible. At the same time, the Company will also conduct follow-up studies on groups who are at high risks of the novel coronavirus to evaluate the preventive effect of JS016 on novel coronavirus infection.
After the Reporting Period, we continued to make significant progress in business operations including the following:
– The Company applied to The Stock Exchange of Hong Kong Limited (the “Hong Kong Stock Exchange”) and obtained approval for the dis-application of Rules 18A.09 to18A.11 of the Rules Governing the Listing of Securities on the Hong Kong Stock Exchange (the “Hong Kong Listing Rules”) (the “Relevant Rules”) to the Company. As a result of the dis-application of the Relevant Rules, the “B” marker ceased to be affixed to the Company’s stock name and stock short name from 15 July 2020.
– The Company completed the issue of A shares. The A shares of the Company were listed and commenced trading on the STAR Market of the Shanghai Stock Exchange on 15 July 2020.
– The Company entered into a research collaboration and license agreement with Revitope Oncology, Inc. to develop next generation of T-cell engaging cancer immunotherapies that utilize Revitope’s proprietary dual-antigen targeting technology platform together with the Company’s antibody technology platform. Revitope will be responsible for designing up to 5 unique T-cell immunotherapeutic drugs against targets selected by the Company. The Company will be granted a world-wide exclusive license on products that result from such agreement.
– The Company’s recombinant humanized anti-Trop2 monoclonal antibody – Tub196 conjugate for injection (product code: JS108), obtained the Clinical Trial Approval issued by the NMPA.
– The Company and IMPACT Therapeutics entered into a joint venture agreement for the formation of a joint venture company (the “JV Company”). The JV Company will mainly engage in the R&D and commercialization of small molecule anti-tumor drugs. IMPACT Therapeutics will contribute for its equity interests by way of injection of a PARP inhibitor Senaparib (IMP4297) as an asset within mainland China, Hong Kong and the Macau Special Administrative Regions. The Company and IMPACT Therapeutics will each own 50% equity interests in the JV Company. Both parties will cooperate in conducting clinical trials, manufacturing, and commercialization preparations for various indications of the IMP4297 project within the above territory.
About Junshi Biosciences
Junshi Biosciences (HKEX: 1877; SSE: 688180) was co-established in December 2012 by alumni of famous universities of China and the United States. The founding team has extensive and solid experience in the cross-border transformation of scientific and technological achievements and substantial expertise in the pharmaceutical industry.
Our priority is researching and developing therapeutic antibodies. We are committed to researching, developing, and industrializing innovative monoclonal antibody drugs and other therapeutic protein drugs. The company has established a diversified R & D pipeline comprising 19 innovative candidate drugs and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune diseases, metabolic diseases, neurologic diseases, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for PD-1 monoclonal antibody and clinical trial approval for anti PCSK9 monoclonal antibody from NMPA. The world’s first in human anti-BTLA antibody for solid tumors was officially approved for drug clinical trials by the FDA and NMPA. From this year onwards, Junshi Biosciences pooled its efforts with Chinese science institutions to co-develop JS016, China’s first neutralizing human monoclonal antibodies against SARS-Cov-2, that has entered clinical trial, part of our continuous innovation for disease control and prevention in China and beyond. We have about 2,000 employees in San Francisco and across Maryland in the United States, as well as Shanghai, Suzhou, Beijing, and Guangzhou, China. For more information, please visit: http://junshipharma.com.
Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-2250 0300
PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800