Ongericimab

SHANGHAI, China, March 29, 2024 (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, announced its financial results for the full year of 2023 and provided corporate updates. FINANCIAL HIGHLIGHTS Total revenue was approximately RMB1,503 million during 2023. The revenue from pharmaceutical products increased by approximately 58% compared to 2022. The sales revenue of TUOYI® (toripalimab) was approximately RMB919 million, representing an increase of approximately 25% compared to the previous year. Total research and development (“R&D”) expenses were approximately RMB1,937 million in 2023, representing a decrease of approximately 19% compared to 2022. The decrease in R&D expenses was mainly due to the strategic management of R&D investments in certain early-stage pipelines, while optimizing resource allocation and focusing on R&D pipelines with greater potential. Loss attributable to owners was RMB2,282 million in 2023, representing a decrease of RMB104 million compared to the previous year. BUSINESS HIGHLIGHTS During 2023, we continued to focus on “unmet medical needs” and have made original, innovative and breakthrough progress in discovery, R&D and commercialization of innovative therapies and novel drugs. Here are the notable achievements and milestones: Advancements in the pipeline: Junshi Biosciences’ innovative R&D field has expanded from monoclonal antibodies to the research and development of more 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 including cancer and autoimmune diseases. The product pipelines cover five major therapeutic areas, including malignant tumors, autoimmune diseases, chronic metabolic diseases, neurologic diseases and infectious diseases. A total of three drugs (TUOYI®, JUNMAIKANG and MINDEWEI) are being commercialized, around 30 assets are undergoing clinical trials, and over 20 drug candidates are at the preclinical drug development stage. In January 2023, the marketing of MINDEWEI (Deuremidevir Hydrobromide Tablets, code: JT001/VV116), an oral nucleoside analog anti-SARS-CoV-2 Category 1 innovative drug, was conditionally approved by the National Medical Products Administration of China (the “NMPA”) for the treatment of adult patients with mild to moderate COVID-19. In February 2023, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (the “MHRA”) accepted the the marketing authorization application (the “MAA”) for toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (“NPC”), as well as toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (“ESCC”). In March 2023, the investigational new drug (“IND”) application for JS010 (a recombinant humanized anti-CGRP monoclonal antibody injection) was approved by the NMPA. In April 2023, the NMPA accepted the supplemental new drug application (“sNDA”) for TUOYI® in combination with chemotherapy as perioperative treatment and monotherapy as consolidation therapy after adjuvant therapy for the treatment of resectable stage III non-small cell lung cancer (“NSCLC”). This application was later approved for marketing in December 2023, marking the first and only approved perioperative therapy for lung cancer domestically. In April 2023, the new drug application (“NDA”) for ongericimab (a recombinant humanized anti-PCSK9 monoclonal antibody, code: JS002) was accepted by the NMPA. In April 2023, the IND application for JS401 (a small interfering RNA (“siRNA”) drug targeting angiopoietin-like protein 3 (“ANGPTL3”) messenger RNA (“mRNA”)) was approved by the NMPA. In May 2023, the NMPA accepted the sNDA for TUOYI® in combination with paclitaxel injection (albumin-bound) for the treatment of PD-L1 positive (CPS ≥ 1) untreated metastatic or recurrent metastatic triple-negative breast cancer. In June and August 2023, the IND application for a randomized, double-blind, placebo-controlled, international multi-center phase III clinical study of tifcemalimab (a recombinant humanized anti-BTLA monoclonal antibody, code: TAB004/JS004) in combination with toripalimab as consolidation therapy in patients with limited-stage small cell lung cancer (“LS-SCLC”) without disease progression following chemo-radiotherapy was approved by the U.S. Food and Drug Administration (the “FDA”) and the NMPA, respectively. In July 2023, the sNDA for TUOYI® in combination with axitinib for the first-line treatment of patients with unresectable or metastatic renal cell carcinoma (“RCC”) was accepted by the NMPA. In July 2023, the sNDA for TUOYI® in combination with etoposide plus platinum as the first-line treatment of extensive-stage small cell lung cancer (“ES-SCLC”) was accepted by the NMPA, which marked the tenth marketing application submitted for TUOYI® in China. In August 2023, the IND application for JS207 (a recombinant humanized anti-PD-1/VEGF bispecific antibody) was approved by the NMPA. In September 2023, the primary endpoint of progression free survival (“PFS”, based on independent radiological review) of a randomized, controlled, multi-center phase III clinical study (NCT03430297) of toripalimab versus dacarbazine for the first-line treatment of unresectable or metastatic melanoma had met the pre-defined efficacy boundary. In October 2023, the FDA approved the Biologics License Application (the “BLA”) for toripalimab (U.S. trade name: LOQTORZI™), in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. Toripalimab is the first and only drug approved in the United States for the treatment of NPC, and is also the first innovative biological drug independently developed and manufactured in China that was approved for marketing by the FDA. In December 2023, the Therapeutic Goods Administration (the “TGA”) of the Australian Government’s Department of Health and Aged Care accepted the New Chemical Entity (the “NCE”) application for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. Additionally, the TGA also granted an orphan drug designation to toripalimab for the treatment of NPC. In December 2023, TUOYI® and MINDEWEI were successfully added to Category B of the National Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (Year 2023) (the “NRDL”) upon negotiations. Notably, three new TUOYI® indications were added, bringing the total to six indications included in the NRDL. TUOYI® is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma. The inclusion of the MINDEWEI indication for adult patients with mild to moderate COVID-19 marked its first official listing in the NRDL. Update on external collaborations In March 2023, the company entered into a shareholders agreement with Rxilient Biotech and its wholly-owned subsidiary, Excellmab. The company would subscribe to the newly issued shares of Excellmab by payment in kind to obtain 40% equity interest in Excellmab. Subject to the fulfillment of the conditions precedent as agreed under the Shareholders Agreement, the company would substantially perform its capital contribution obligations, and express its intention to enter into a license agreement with Excellmab in the form agreed upon by the parties at the time of entering into the Shareholders Agreement, thereby granting Excellmab an exclusive license and other relevant rights to develop and commercialize intravenous toripalimab in Thailand, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines and Vietnam. According to the R&D progress of toripalimab and other matters, Junshi Biosciences may receive a milestone payment of up to approximately US$4.52 million, plus a percentage of royalties on the net sales. In May 2023, Junshi Biosciences entered into an exclusive license and commercialization agreement with Dr. Reddy’s, pursuant to which the company agreed to grant Dr. Reddy’s a license to develop and exclusively commercialize toripalimab injection in Brazil, Mexico, Colombia, Argentina, Peru, Chile, Panama, Uruguay, India and South Africa. Dr. Reddy elected to expand the scope of the license to cover Australia, New Zealand and nine other countries. 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. Four of the company’s innovations have already reached the Chinese or international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody, approved in both China and the US. Additionally, more than 30 drugs are currently in clinical development. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 3,000 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

SHANGHAI, China, March 31, 2023 (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, announced financial results for the 2022 full year and provided corporate updates. FINANCIAL HIGHLIGHTS Total revenue was approximately RMB 1,453 million during 2022. Sales revenue from TUOYI® (toripalimab) alone was approximately RMB 736 million, representing an increase of approximately 79% compared to 2021. With the increase in commercialization capability, as well as the approval and launch of two more significant indications for TUOYI® in 2022, the company’s sales in the domestic market are gradually entering a positive cycle. Total research and development (“R&D”) expenses were approximately RMB 2,384 million in 2022, representing an increase of approximately 15% compared to 2021. The increase in R&D expenses was mainly due to (i) the continuous increase in R&D investment and product pipeline enrichment; (ii) the acceleration in the progress of current clinical projects and development of reserved R&D projects; and (iii) the reservation of the R&D team. Net cash from financing activities was approximately RMB 4,643 million in 2022, which was mainly attributable to the successful issuance of the company’s new A shares on the STAR Market of the Shanghai Stock Exchange on December 2nd, 2022. Net cash inflow from the issuance was RMB 3,748 million and new bank borrowings contributed a net cash inflow of RMB 840 million. These net cash inflows from financing activities fully covered the cash outflows from operating and investing activities, leading to the increase of RMB 2,492 million in bank balances and cash. Loss attributable to the owners of the company was RMB 2,386 million in 2022, representing an increase of RMB 1,667 million compared to 2021. This increase was mainly due to out-licensing, which resulted in the decline of revenue. BUSINESS HIGHLIGHTS During 2022, we focused on addressing “unmet clinical needs” and have made original, innovative and breakthrough progress in the discovery, R&D, production and commercialization of innovative therapies and drugs. Our efforts have filled various gaps domestically and have positioned us as global leaders in some fields. The following are some of our greatest achievements and milestones in 2022: Advancements 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. In 2022, a total of four drugs (TUOYI®, JUNMAIKANG®, MINDEWEI (民得維®) and etesevimab) were commercialized in China or abroad, around 30 assets are undergoing clinical trials with ongericimab, bevacizumab and PARP inhibitor under Phase III clinical trials, and over 20 drug candidates are under pre-clinical drug development. In February 2022, the dosing of the first patient was completed in the Phase III clinical trial of TUOYI® 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 (the “NMPA”). In March 2022, the marketing of JUNMAIKANG® (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 examining MINDEWEI were published in Acta Pharmacologica Sinica, a renowned journal in the pharmaceutical industry. These results revealed that MINDEWEI exhibited satisfactory safety and tolerability in healthy subjects, had a rapid oral absorption rate, 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 from the pre-clinical in vivo efficacy study evaluating MINDEWEI as a potent inhibitor of respiratory syncytial virus were published online in Signal Transduction and Targeted Therapy (STTT, IF: 38.104), a journal under Nature. In April 2022, TUOYI® was granted orphan-drug designation by the FDA for the treatment of small-cell lung cancer (“SCLC”), marking the fifth FDA orphan-drug designation obtained by TUOYI®. In May 2022, the IND application for JS105, a PI3K-α inhibitor jointly developed by Risen (Suzhou) Biosciences Co., Ltd. (“Risen Biosciences”) and the company, was approved by the NMPA. In May 2022, a Phase III registration clinical study (NCT05341609) comparing MINDEWEI to nirmatrelvir tablet/ritonavir tablets (namely PAXLOVID) for the early treatment of mild to moderate coronavirus disease 2019 (“COVID-19”) met its prespecified primary and secondary endpoints. The MINDEWEI group achieved a shorter median time to sustained clinical recovery and attained statistical superiority, providing compelling evidence for MINDEWEI’s ability to accelerate the remission of COVID-19 symptoms. The relevant research results were published online in a globally authoritative journal, The New England Journal of Medicine (NEJM, IF: 176.082). 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. In June 2022, the IND applications for JS116 (small molecule irreversible covalent inhibitor of KRASG12C) and JS113 (fourth-generation EGFR inhibitor) were approved by the NMPA. In July 2022, the IND application for JS105 (PI3K-α inhibitor) was approved by the FDA. In July 2022, the IND application for JS203 (recombinant humanized anti-CD20 and CD3 bispecific antibody) was approved by the NMPA. In August 2022, the IND application for JS110 (XPO1 inhibitor) was approved by the FDA. In August 2022, the IND application for TAB009/JS009 (recombinant humanized anti-CD112R monoclonal antibody injection) was approved by the NMPA. In September 2022, the NMPA approved the sNDA for TUOYI® in combination with pemetrexed and platinum as the first-line treatment of unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (“NSCLC”) that is negative for both epidermal growth factor receptor (“EGFR”) mutations and anaplastic lymphoma kinase (“ALK”) mutations. This marked the sixth indication for TUOYI® approved by the NMPA. In October 2022, the IND application for JS015 (recombinant humanized anti-DKK1 monoclonal antibody injection) was approved by the NMPA. In November 2022, the supplemental application for additional indications of JUNMAIKANG® (adalimumab) for the treatment of Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, pediatric plaque psoriasis and pediatric Crohn’s disease was approved by the NMPA. In December 2022, the marketing authorization applications (the “MAA”) for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC, as well as toripalimab in combination with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC, were accepted by the European Medicines Agency (the “EMA”). Update on external collaborations In January 2022, under the exclusive license and commercialization agreement with Coherus BioSciences, Inc. (“Coherus”) in February 2021, Coherus initiated the procedure for exercising the option to obtain a license for the development of the recombinant humanized anti-TIGIT monoclonal antibody (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-time exercise payment of US$35 million to the company 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. (“Wigen Biomedicine”) where the company granted Wigen Biomedicine the licenses for 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 expanding our pipeline layout in the field of cancer treatment. In June 2022, the company established a cooperation with Sun Yat-sen University Cancer Center and obtained three patent applications, which included 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. In December 2022, the company entered into an exclusive license and commercialization agreement with Hikma MENA FZE (“Hikma”) and granted Hikma an exclusive license to develop and commercialize the toripalimab injection in all 20 Middle East and North Africa (“MENA”) markets, including Jordan, Kingdom of Saudi Arabia, United Arab Emirates, Qatar, Morocco and Egypt. The company may receive payments of up to an aggregate of US$12 million, along with high-teen tiered royalties of up to 20% of the net sales. In addition, the right of first negotiation was granted to Hikma for the future commercial rights of three drugs currently in the development phase in one or more countries within the collaboration territory. Business operations In May 2022, the NMPA approved the production base in Lingang, Shanghai to produce commercial batches of TUOYI® in parallel with the company’s Wujiang production base in Suzhou. The Shanghai Lingang Production Base was constructed in accordance with the CGMP standard, and its production capacity has now reached 42,000L following the addition of 12,000L of production capacity last year. By virtue of economies of scale, the addition of the Shanghai Lingang Production Base has expanded production capacity and given the company the potential advantage of competitive production costs. In December 2022, the company completed the issuance of 70 million new A shares to 17 target subscribers at an issue price of RMB 53.95 per Share. The gross proceeds amounted to RMB 3,776.50 million, which will be allocated towards R&D projects for innovative drugs, Shanghai Junshi Biotech headquarters and R&D base project. 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, has been approved for marketing in China and Uzbekistan. 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 about 3,000 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