WJ-13404

Clinical trials of core drug candidates are progressing steadily with the debut of the company’s FIH asset Toripalimab’s sales performance is consistently improving; the US BLA is under review SHANGHAI, China, Aug. 31, 2022 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, today announced its 2022 interim financial results and provided corporate updates. FINANCIAL HIGHLIGHTS Total revenue reached approximately RMB 946 million in the first half of 2022. In particular, the sales revenue of TUOYI® (toripalimab) was approximately RMB 298 million, representing an increase of approximately 195% compared to the second half of 2021. The sales revenue of TUOYI® still reached approximately RMB 188 million during the second quarter of 2022, representing an increase of approximately 70% compared to the first quarter of 2022 in spite of the rebound in COVID-19 infections in Shanghai City and Jilin Province. Total research and development (“R&D”) expenses were approximately RMB 1,062 million for the H1 2022, representing an increase of approximately 12% compared to the corresponding period in 2021. The increase in R&D expenses was mainly due to (i) continuous advancement of the R&D process leading to increasing clinical research expenses; and (ii) the expansion of the R&D team. Loss was RMB 998 million during the H1 2022, representing an increase of RMB 1,009 million compared to the corresponding period in 2021, which was mainly attributable to the decline of revenue from out-licensing. Net cash from financing activities was approximately RMB 535 million for the H1 2022. As of 30 June 2022, the bank balances and cash was approximately RMB 3,407 million with no significant fluctuations compared to 31 December 2021. BUSINESS HIGHLIGHTS During the first half of 2022, Junshi Biosciences focused on “unmet clinical needs” and made original, unprecedented and breakthrough progress in the discovery, R&D, production and commercialization of innovative drugs and therapies, which have filled various gaps in China and are leading in related fields globally. The following achievements and milestones were attained: Advancement in pipeline: The company’s innovative R&D field has expanded from monoclonal antibodies to the development of various drug modalities, including small molecules drugs, polypeptide drugs, antibody drug conjugates (ADCs), bi-specific or multi-specific antibodies and nucleic acid drugs, as well as the exploration of next-generation innovative therapies for cancer and autoimmune diseases. Product pipelines cover five major therapeutic areas including malignant tumors, autoimmune diseases, chronic metabolic diseases, neurologic diseases and infectious diseases. There are three assets (toripalimab, etesevimab and adalimumab) under commercialization, around 30 assets under clinical trials with ongericimab, VV116, bevacizumab and PARP inhibitor under Phase III clinical trials, and over 20 drug candidates under pre-clinical drug development. In February 2022, the dosing of the first patient was completed in the Phase III clinical trial of toripalimab in combination with standard chemotherapy as the adjuvant treatment after radical resection of gastric or esophagogastric junction adenocarcinoma (JUPITER-15 study, NCT05180734). In February 2022, the Investigational New Drug (“IND”) application for JS112 (Aurora A inhibitor) was approved by the National Medical Products Administration of China (“NMPA”). In March 2022, the marketing of JUNMAIKANG (君邁康)® (adalimumab) for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis was approved by the NMPA. In March 2022, the results of three Phase I clinical studies of VV116 (JT001) were published in Acta Pharmacologica Sinica, a renowned journal in the pharmaceutical field, which showed that VV116 exhibited satisfactory safety and tolerability in healthy subjects, was rapidly absorbed orally, and could be administered orally under fasting or normal diet conditions. In March 2022, the IND application for JS107 (recombinant humanized anti-Claudin18.2 monoclonal antibody-MMAE conjugate) was approved by the NMPA. In March 2022, the IND application for JS001sc (a toripalimab subcutaneous injection formulation) was approved by the NMPA. In April 2022, the IND application of TAB009/JS009 (recombinant humanized anti-CD112R monoclonal antibody injection) for the treatment of advanced solid tumors was approved by the United States Food and Drug Administration (the “FDA”). In April 2022, the results of the pre-clinical in vivo efficacy study of VV116 (JT001) as a potent inhibitor of respiratory syncytial virus was published online in Signal Transduction and Targeted Therapy (STTT, IF: 38.104). In April 2022, TUOYI® was granted orphan-drug designation by the FDA for the treatment of small cell lung cancer (“SCLC”), which was the fifth FDA orphan-drug designation obtained by TUOYI®. In May 2022, the IND application for JS105 (PI3K-α inhibitor) jointly developed by the Company and Risen (Suzhou) Biosciences Co., Ltd. was approved by the NMPA. In May 2022, the IND application for JS203 (recombinant humanized anti-CD20 and CD3 bispecific antibody) was accepted by the NMPA and approved in July 2022. In May 2022, a Phase III registration clinical study (NCT05341609) of VV116 (JT001) versus nirmatrelvir tablet/ritonavir tablet (namely PAXLOVID) for the early treatment of mild to moderate coronavirus disease 2019 (“COVID-19”) reached its pre-specified primary endpoints and secondary efficacy endpoints. The VV116 (JT001) group achieved a shorter median time to sustained clinical recovery and attained statistical superiority, providing strong evidence that such therapy could accelerate the remission of COVID-19 symptoms. In May 2022, the supplemental new drug application (“sNDA”) for TUOYI® in combination with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (“ESCC”) was approved by the NMPA, which was also the fifth indication of TUOYI® approved by the NMPA. In June 2022, the IND application for JS116 (small molecule irreversible covalent inhibitor of KRASG12C) was approved by the NMPA. In June 2022, the IND application for JS113 (fourth-generation EGFR inhibitor) was approved by the NMPA. In June 2022, almost 40 data presentations of toripalimab and tifcemalimab (anti-BTLA mAb) across multiple tumor types were released at the American Society of Clinical Oncology (ASCO) annual meeting. Tifcemalimab made its debut with data from single-agent and dual-immunotherapy studies, first as monotherapy in patients with advanced solid tumors and then in combination therapy for the treatment of relapsed/refractory lymphomas (#230, #297). As a first-in-class drug, the initial data release of tifcemalimab was an important milestone for BTLA-targeted drugs in the treatment of tumors. In July 2022, the FDA accepted for review the resubmission of the Biologics License Application (the “BLA”) for toripalimab in combination with gemcitabine/cisplatin for the first-line treatment of patients with advanced recurrent or metastatic NPC and toripalimab monotherapy for second-line or above treatment of recurrent or metastatic NPC after platinum-containing chemotherapy. The FDA has set the Prescription Drug User Fee Act (PDUFA) action date on 23 December 2022. If approved, the company’s partner Coherus plans to launch toripalimab in the United States in the first quarter of 2023, and toripalimab will be the first and only immuno-oncology agent for NPC in the United States. In July 2022, toripalimab was granted orphan-drug designation by the European Commission for the treatment of NPC based on a favorable opinion from the European Medicines Agency (“EMA”). With this new addition, toripalimab had been granted a total of six orphan-drug designations by the drug regulatory agencies in the European Union and in the United States, the other five involving the treatment of mucosal melanoma, nasopharyngeal cancer, soft tissue sarcoma, esophageal cancer and SCLC. In July 2022, the FDA approved the IND application of JS105 (PI3K-α inhibitor) in combination with fulvestrant for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor-2 (HER-2) negative patients as well as both female (postmenopausal) and male patients with PIK3CA-mutated advanced or metastatic breast cancer. In August 2022, the IND application for JS110 (small molecule inhibitor of the nuclear export protein XPO1) was approved by the FDA. The National Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (“NRDL”) (2021 Edition) was officially implemented on 1 January 2022, and TUOYI® continues to be included in Category B in the NRDL. Two indications were added, one for the treatment of patients with recurrent/metastatic NPC after failure of at least two lines of prior systemic therapy, and the other for the treatment of patients with locally advanced or metastatic urothelial carcinoma (“UC”) who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Update on external collaborations In January 2022, based on the exclusive license and commercialization agreement with Coherus BioSciences, Inc. (“Coherus”) in February 2021, Coherus initiated the procedure for exercising the option of the recombinant humanized anti-TIGIT monoclonal antibody(TAB006/JS006), one of the option programs, in order to be licensed to develop TAB006/JS006 or any product containing TAB006/JS006 in the United States and Canada for the treatment or prevention of human diseases. Coherus made a one-off exercise payment of US$ 35 million to us, and will pay up to an aggregate of US$ 255 million upon reaching the corresponding milestones, plus 18% royalty on the annual net sales of any product that contains TAB006/JS006 in the collaboration territory. In March 2022, the company entered into a licensing and cooperation agreement with Wigen Biomedicine Technology (Shanghai) Co., Ltd. to obtain the licenses of four small molecule anti-tumor drugs, namely JS120 (second-generation irreversible IDH1 inhibitor), JS121 (SHP2 inhibitor), JS122 (second-generation irreversible FGFR2 selective inhibitor) and JS123 (ATR inhibitor), thus further enriching our pipeline layout in the field of cancer treatment. In June 2022, the company entered into a collaboration with Sun Yat-sen University Cancer Center, and the company obtained three patent applications including the “Application of a Bacterium in Preparation of a Synergist of an Immune Checkpoint Inhibitor” and their related technologies and rights by way of exclusive license. Upgrade in commercial production capacity: In May 2022, the NMPA approved the production base in Lingang, Shanghai, for the production of commercial batches of TUOYI® in conjunction with the company’s Wujiang production base in Suzhou. The Shanghai Lingang Production Base was constructed in accordance with the CGMP standard, with a production capacity of 30,000L in the first phase of the project. By virtue of economies of scale, the expansion of production capacity brought about by the Shanghai Lingang Production Base will enable the company to gain the advantage of having more competitive production costs. Financing activity highlights: In April 2022, the resolutions in relation to the proposed issuance of no more than 70 million A shares of the company to target subscribers under the general mandate was passed by the shareholders at the 2022 first extraordinary general meeting. The proceeds are expected to be no more than RMB 3.969 billion, which will be used for R&D projects of innovative drugs and the technology headquarters and R&D base project. The issuance is still subject to the approval of the Shanghai Stock Exchange and the approval of registration from the China Securities Regulatory Commission. About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA monoclonal antibody for the treatment of various cancers was the first in the world to be approved for clinical trials by the FDA and NMPA and has since entered Phase Ib/II trials in both China and the US. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In the face of the pandemic, Junshi Biosciences’ response was strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, the Institute of Microbiology of the Chinese Academy of Science and Lilly. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide. As of December 3 2021, over 700,000 patients have been treated with bamlanivimab or bamlanivimab and etesevimab, potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths. Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, is in global Phase III clinical trials. A Phase III clinical study (NCT05341609) comparing the efficacy and safety of VV116 versus nirmatrelvir/ritonavir (“PAXLOVID”) for patients with mild to moderate COVID-19 who are at high risk for progression to severe COVID-19, has reached its pre-specified primary endpoint and secondary efficacy endpoint. The study results show that compared to PAXLOVID, VV116 provided patients with a shorter median time to sustained clinical recovery, while achieving statistical superiority. The JS016 and VV116 programs are a part of the company’s continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has more than 3,100 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc). For more information, please visit: . Junshi Biosciences Contact Information IR Team: Junshi Biosciences info@junshipharma.com + 86 021-6105 8800 PR Team: Junshi Biosciences Zhi Li zhi_li@junshipharma.com + 86 021-6105 8800