Shanghai Junshi Biosciences Co., Ltd.

SHANGHAI, China, April 07, 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 that the National Medical Products Administration (“NMPA”) has approved the supplemental new drug application (“sNDA”) for toripalimab (product code: JS001) in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (“RCC”). This is the first approved immunotherapy for renal carcinoma in China. Renal carcinoma is the third most common malignancy of the urinary system globally, and RCC accounts for 80%~90% of all cases of renal carcinoma. There were approximately 77,000 new cases of and 46,000 deaths due to renal carcinoma in China in 2022. Distant metastasis occurred in about one-third of renal carcinoma patients at initial diagnosis, and in 20%-50% of localized patients after nephrectomy. According to the risk classification of the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC), the median overall survival (“OS”) of patients with low, medium and high risk metastatic RCC receiving anti-vascular targeted treatment were 35.3, 16.6 and 5.4 months, respectively. Therefore, compared to low-risk patients, the clinical needs for new treatment options are more urgent for patients with medium and high risk advanced RCC. The approval of the sNDA is mainly based on data from the RENOTORCH study (NCT04394975), a multi-center, randomized, open-label, active-controlled Phase 3 clinical study led by principal investigators Professor Jun GUO from Peking University Cancer Hospital and Professor Yiran HUANG from Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. The study was conducted across 47 medical centers, and represents the first pivotal Phase 3 clinical study of immunotherapy for patients with advanced RCC in China. A total of 421 randomized patients with medium to high risk unresectable or metastatic RCC were enrolled in the study and randomly assigned in a 1:1 ratio to receive toripalimab in combination with axitinib (n=210) or sunitinib alone (n=211). The primary endpoint is progression free survival (“PFS”) as assessed by the Independent Review Committee (“IRC”), and secondary endpoints include PFS as assessed by investigators, objective response rate (“ORR”) as assessed by IRC or investigators, duration of response (“DoR”), disease control rate (DCR), OS, safety profile, etc. Previously, the study results of RENOTORCH made its debut at the Proffered Paper Session of the European Society for Medical Oncology (ESMO) congress 2023. The full text was simultaneously published in Annals of Oncology, the official journal of ESMO. The study data showed that, based on the assessment results of IRC, compared with sunitinib monotherapy, toripalimab in combination with axitinib for the treatment significantly prolonged the PFS of patients by nearly twofold (median PFS: 18.0 vs. 9.8 months, P=0.0028), and the risk of disease progression or death was reduced by 35% (hazard ratio [HR]=0.65; 95% CI: 0.49, 0.86). In addition, the ORR was higher (56.7% vs. 30.8%, P<0.0001) and the DoR was longer (median DoR: not reached vs 16.7 months; HR=0.61) in the toripalimab group. The OS of the toripalimab group also showed a clear trend of benefit (median OS: not reached vs 26.8 months), and the risk of death was reduced by 39% (HR=0.61; 95%CI: 0.40, 0.92). In terms of safety, toripalimab in combination with axitinib demonstrated a favorable safety and tolerability profile, and no new safety signals were observed. “From a global perspective, targeted therapy in combination with immunotherapy has become the standard treatment approach for advanced RCC,” said Professor Jun GUO from Peking University Cancer Hospital. “However, no such treatments have been approved in China. The approval of toripalimab’s new indications opens a new chapter in combined targeted therapy and immunotherapy in China, and it will transform current clinical practices for advanced RCC and introduce new treatment options for medium to high-risk patients!” “The treatment methods for advanced RCC are limited, especially for medium to high risk patients, who often face suboptimal prognoses,” said Professor Yiran HUANG from Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. “The approval of toripalimab combined with axitinib addresses the gap in first-line immunotherapy for renal cancer in China. Compared to targeted monotherapy, toripalimab combined with targeted therapy will significantly improve patients’ PFS, offering promising prospects for many advanced RCC patients in China.” “Thank you to all medical professionals, patients, and R&D personnel involved in the RENOTORCH study for their contributions,” said Dr. Jianjun ZOU, Global Research and Development President of Junshi Biosciences. “Their dedication has led to a pioneering breakthrough in renal cancer, first of its kind in China! Junshi Biosciences will remain committed to addressing domestic clinical needs and continue investing in research and development to help patients live longer and better!” About Toripalimab Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells. More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and Europe. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin. In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are eight approved indications for toripalimab in China: unresectable or metastatic melanoma after failure of standard systemic therapy;recurrent or metastatic nasopharyngeal carcinoma (“NPC”) after failure of at least two lines of prior systemic therapy;locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (“ESCC”);in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (“NSCLC”);in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC;in combination with axitinib for the first- line treatment of patients with medium to high risk unresectable or metastatic RCC. The first six indications have been included in the National Reimbursement Drug List (NRDL) (2023 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma. In the United States, the U.S. FDA has approved the Biologics License Application for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy in October 2023. The FDA has granted toripalimab 2 Breakthrough Therapy designations for the treatment of NPC, 1 Fast Track designation for the treatment of mucosal melanoma, and 5 Orphan Drug designations for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer (SCLC). In Europe, marketing authorization applications (MAA) were accepted by the European Medicines Agency (EMA) and the MHRA for 1) toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC and 2) toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC, in December 2022 and February 2023. In Australia, the new chemical entity (NCE) application was accepted by the Australia Therapeutic Goods Administration (“TGA”) in November 2023. The TGA has also granted toripalimab an Orphan Drug designation for the treatment of NPC. In Singapore, the NDA application was accepted by the Singapore Health Sciences Authority (“HSA”) in January 2024. The HSA has also granted priority review designation for the NDA. 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 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: http://junshipharma.com. Junshi Biosciences Contact InformationIR Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-6105 8800 PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86 021-6105 8800

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

Coherus BioSciences' latest layoffs come as a result of a “sharpened focus” in oncology and a subsequent restructuring, the company said. About a year after launching a prior round of layoffs, Coherus BioSciences is again reducing its head count, this time by 30%. Coherus unveiled the latest job cuts Wednesday alongside its full-year 2023 financial results. The company was previously left with about 300 employees after a reduction last March forced 60 staffers out of the door. The latest round of cuts started March 7. Coherus aims to complete the reductions by the end of the year and save more than $25 million in annual costs. The layoffs come as a result of a “sharpened focus” in oncology and a subsequent restructuring, Coherus said. The company in January announced that it will sell its ophthalmology franchise surrounding its Lucentis biosimilar to Sandoz for $170 million in cash. The latest job cuts include 35 employees as part of the ophthalmology divestiture. The Lucentis copycat, branded as Cimerli, generated $52 million in fourth-quarter sales for Coherus, bringing its full-year total to $125 million. Udenyca, the other biosimilar product in Coherus’ portfolio, references Amgen’s Neulasta. The biosim generated $36 million in the fourth quarter, down from $38 million in the same period last year, but up sequentially. An on-body autoinjector presentation of Udenyca was approved by the FDA toward the end of 2023, and Coherus just launched that version in February. In just a few weeks, 138 accounts have already orded the on-body product, Coherus Chief Commercial Officer Paul Reider said during a call Wednesday. Citing IQVIA data, Coherus said Udenyca held about 26% of the U.S. market share as of March 1. Coherus is rebranding itself from a biosimilar developer to an innovative cancer drug player. The Junshi Biosciences-partnered PD-1 inhibitor Loqtorzi is leading that charge. After a first-in-class FDA approval in nasopharyngeal carcinoma in October, Coherus launched Loqtorzi at the beginning of 2024. Still, the company recorded $600,000 in Loqtorzi sales in the fourth quarter from wholesaler stockpiling, Reider said. The PD-1 latecomer has received payer coverage under its label for about 95% of targeted patients, he added. In the first few weeks of its launch, Coherus saw 59 targeted nasopharyngeal cancer accounts ordering Loqtorzi, and the company described the uptake as “tracking to expectations.” To further help strengthen Coherus’ capital position, the California company has agreed with Junshi to delay and potentially reduce a $25 million milestone payment that was previously due in the first quarter. Now, Coherus is slated to pay its Chinese partner $12.5 million by June and the rest in the first quarter of 2025, with the possibility to cut back on the second tranche by selling the drug’s Canadian rights, the company said.