A Prospective，Single Arm, Multicenter Clinical Study of BTLA Monoclonal Antibody JS004 (B/T Lymphocyte Attenuator Factor Monoclonal Antibody) in Combination With Toripalimab in Patients With Unresectable or Advanced Renal Cell Carcinoma Who Had Failed Previous Immunotherapy

This study is A prospective，single arm, multicenter clinical study of BTLA monoclonal antibody JS004 (B/T lymphocyte attenuator factor monoclonal antibody) in combination with toripalimab in patients with unresectable or advanced renal cell carcinoma who had failed previous immunotherapy Subjects will receive JS004（B/T lymphocyte attenuator factor monoclonal antibody） plus Toripalimab until disease progression, development of unacceptable toxic effects, death, a decision by the physician or patient to withdraw from the trial. The primary endpoint is ORR per RECIST v1.1 as assessed by investigators(continuous treatment for up to 2 years).

Start Date30 Oct 2025

Sponsor / Collaborator-

NCT07101614

/ Not yet recruitingPhase 2IIT

An Open-label, Randomized, Multi-center, Multi-cohort Clinical Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chemotherapy Alone as Neoadjuvant Therapy for Stage II-III Triple-negative Breast Cancer (TNBC).

The objective of this study is to evaluate the efficacy and safety of chemotherapy plus toripalimab, with or without JS004,as neoadjuvant therapy for patients with triple-negative breast cancer (TNBC). TNBC patients were randomly assigned in a 2:2:1 ratio to receive either JS004 plus toripalimab plus chemotherapy, toripalimab plus chemotherapy, or chemotherapy alone.Surgery will be performed within 5 weeks after the last dose of neoadjuvant treatment.

Start Date01 Sep 2025

Sponsor / Collaborator

ShengJing Hospital

NCT06924606

/ RecruitingPhase 2

A Phase II Study of JS207 (PD-1/VEGF Dual Antibody) in Combination With or Without JS004 or Docetaxel in Advanced Non-small Cell Lung Cancer With Disease Progression During or After the Treatment of Platinum-based Chemotherapy and Immunotherapy

This is a multiple-arm, open phase II clinical trial evaluating the safety, tolerability,and preliminary efficacy of JS207 in NSCLC after progression following Platinum-based chemotherapy and immunotherapy.

Start Date15 Jul 2025

Sponsor / Collaborator

Shanghai Junshi Biosciences Co., Ltd.

100 Clinical Results associated with Tifcemalimab

100 Translational Medicine associated with Tifcemalimab

100 Patents (Medical) associated with Tifcemalimab

Literatures (Medical) associated with Tifcemalimab

15 Jul 2025·CLINICAL CANCER RESEARCH

Phase I/II Study of Tifcemalimab, an Anti–B- and T-lymphocyte Attenuator Antibody, in Combination with Toripalimab in Previously Treated Advanced Lung Cancer

Article

Author: Wang, Jie ; Zhang, Wei ; Lv, Dongqing ; Xu, Jing ; Yi, Tienan ; Wang, Xi-Cheng ; Liu, Xiao-Qing ; Xia, Bing ; Yang, Runxiang ; Wang, QiMing ; Peng, Bang.an ; Han, Liang ; Su, Man ; Li, Chong ; Shen, Minjie ; Cheng, Ying ; Yu, Yan

Abstract:

Purpose::

Tifcemalimab is a recombinant humanized IgG4k monoclonal antibody targeting B- and T-lymphocyte attenuator. Co-blockade of B- and T-lymphocyte attenuator and programmed death-1 pathways improved outcomes in nonclinical models. This phase I/II trial evaluated the safety and preliminary efficacy of tifcemalimab plus toripalimab in advanced lung cancer.

Patients and Methods::

Eligible patients with pathologically confirmed advanced non–small cell lung cancer (NSCLC) without sensitive EGFR variation and anaplastic lymphoma kinase fusion who failed standard treatment including one PD-1/PD-L1 inhibitor or those with refractory extensive-stage small cell lung cancer (SCLC) received tifcemalimab (200 mg) and toripalimab (240 mg) every 3 weeks intravenously until disease progression or intolerable toxicity. The Simon two-stage optimal design was used in the expansion part. The primary endpoints included safety and objective response rate (ORR) per RECIST version 1.1.

Results::

Twenty-four patients with NSCLC and 43 with SCLC were enrolled (median age of all patients, 60.0 years). All patients with NSCLC and 14 (32.6%) with SCLC had received previous immunotherapy. Fifty-five (82.1%) patients experienced treatment-related adverse events, and five (7.5%) patients reported grade ≥3 immune-related adverse events. For NSCLC, the ORR was 4.3%, and disease control rate was 47.8%. The median progression-free survival and overall survival were 1.5 and 18.9 months, respectively. For SCLC, the ORR and disease control rate were 35.0% and 55.0%, respectively. The median duration of response, progression-free survival, and overall survival were 5.7, 2.8, and 12.3 months, respectively.

Conclusions::

Tifcemalimab plus toripalimab showed promising antitumor activities with acceptable safety, especially in advanced refractory SCLC.

01 Mar 2023·Translational research : the journal of laboratory and clinical medicine

Targeting tumor-associated MUC1 overcomes anoikis-resistance in pancreatic cancer

Article

Author: Mukherjee, Pinku ; De, Chandrav ; Shwartz, Sophia ; Zhou, Ru ; Mitra, Bhaskar ; Sanders, Alexa ; Bose, Mukulika ; Brouwer, Cory ; Lala, Priyanka

The third leading cause of cancer-related deaths in the United States is pancreatic cancer, more than 95% of which is pancreatic ductal adenocarcinoma (PDA). The incidence rate of PDA nearly matches its mortality rate and the best treatment till date is surgical resection for which only 25% are eligible. Tumor recurrence and metastasis are the main causes of cancer-related mortality. MUC1 is a transmembrane glycoprotein expressed on most epithelial cells. It is overexpressed and aberrantly glycosylated in cancer and is known as tumor-associated MUC1 (tMUC1). More than 80% of PDAs express tMUC1. A monoclonal antibody called TAB004 has been developed specifically against human tMUC1 extracellular domain. We report that treatment with TAB004 significantly reduced the colony forming potential of multiple PDA cell lines while sparing normal pancreatic epithelial cell line. Binding of TAB004 to tMUC1 compromised desmosomal integrity, induced ER stress and anoikis in PDA cells. The mechanisms underlying TAB004's antitumor effects were found to be reduced activation of the EGFR-PI3K signaling pathway, and degradation of tMUC1, thereby reducing expression of its transcriptional targets, c-Src and c-Myc. This reduction in oncogenic signaling triggered anoikis as indicated by reduced expression of antiapoptotic proteins, PTRH2 and BCL2. TAB004 treatment slowed the growth of PDA xenograft compared to IgG control and enhanced survival of mice when combined with 5-FU. Since TAB004 significantly reduced colony forming potential and triggered anoikis in the PDA cells, we suggest that it could be used as a potential prophylactic agent to curb tumor relapse after surgery, prevent metastasis and help increase the efficacy of chemotherapeutic agents.

01 Jan 2020·TheranosticsQ1 · MEDICINE

Preclinical evaluation of an ¹¹¹In/²²⁵Ac theranostic targeting transformed MUC1 for triple negative breast cancer

Q1 · MEDICINE

ArticleOA

Author: Mukherjee, Pinku ; Wu, Shu-Ta ; Coelho, Richard ; Kelly, Vanessa J ; Nair, Surabhi ; Puri, Rahul ; Ilovich, Ohad ; Gottumukkala, Vijay ; Erick, Timothy ; Palmer, Keryn

Rationale: Transformed MUC1 (tMUC1) is a cancer-associated antigen that is overexpressed in >90% of triple-negative breast cancers (TNBC), a highly metastatic and aggressive subtype of breast cancer. TAB004, a murine antibody targeting tMUC1, has shown efficacy for the targeted delivery of therapeutics to cancer cells. Our aim was to evaluate humanized TAB004 (hTAB004) as a potential theranostic for TNBC. Methods: The internalization of hTAB004 in tMUC1 expressing HCC70 cells was assessed via fluorescent microscopy. hTAB004 was DOTA-conjugated and radiolabeled with Indium-111 or Actinium-225 and tested for stability and tMUC1 binding (ELISA, flow cytometry). Lastly, in vivo biodistribution (SPECT-CT), dosimetry, and efficacy of hTAB004 were evaluated using a TNBC orthotopic mouse model. Results: hTAB004 was shown to bind and internalize into tMUC1-expressing cells. A production method of ²²⁵Ac-DOTA-hTAB004 (yield>97%, RCP>97% SA=5 kBq/µg) and ¹¹¹In-DOTA-hTAB004 (yield>70%, RCP>99%, SA=884 kBq/µg) was developed. The labeled molecules retained their affinity to tMUC1 and were stable in formulation and mouse serum. In NSG female mice bearing orthotopic HCC70 xenografts, the in vivo tumor concentration of ¹¹¹In-DOTA-hTAB004 was 65 ± 15 %ID/g (120 h post injection). A single ²²⁵Ac-DOTA-hTAB004 dose (18.5 kBq) caused a significant reduction in tumor volume (P<0.001, day 22) and increased survival compared to controls (P<0.007). The human dosimetry results were comparable to other clinically used agents. Conclusion: The results obtained with hTAB004 suggest that the ¹¹¹In/²²⁵Ac-DOTA-hTAB004 combination has significant potential as a theranostic strategy in TNBC and merits further development toward clinical translation.

News (Medical) associated with Tifcemalimab

29 Mar 2025

·www.globenewswire.com

Junshi Biosciences Announces 2024 Full Year Financial Results and Provides Corporate Updates

SHANGHAI, March 28, 2025 (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 2024 and provided corporate updates. FINANCIAL HIGHLIGHTS Total revenue of Junshi Biosciences was approximately RMB1,948 million in 2024, representing an increase of approximately 30% compared to 2023, which was mainly due to the increase in revenue from pharmaceutical products, in particular: the domestic sales revenue of our core product, toripalimab, was approximately RMB1,501 million, representing an increase of approximately 66% compared to 2023.Total research and development (“R&D”) expenses of the company were approximately RMB1,275 million in 2024, representing a decrease of approximately 34% compared to 2023. The decrease in R&D expenses was mainly due to the company’s cost control policy and efforts to optimize resource allocation and focus on R&D pipelines with greater potential. In addition, a number of clinical trials of our core product, toripalimab, successively met the primary endpoints, which also contributed to the natural decline of R&D expenditure.Loss attributable to owners of the company decreased to RMB1,282 million in 2024, representing a decrease of approximately RMB999 million or approximately 44% compared to 2023.As of the end of 2024, the company’s aggregate balance of bank balances and cash and financial products was approximately RMB2,917 million, ensuring a relatively sufficient cash position to support the company’s development. BUSINESS HIGHLIGHTS During 2024, our commitment to addressing “unmet medical needs” has driven original, innovative and breakthrough progress in the discovery, R&D and commercialization of innovative therapies and drugs through accelerating international development. 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 various drug modalities, including small molecule drugs, polypeptide drugs, antibody drug conjugates (ADCs), bi-specific or multi-specific antibodies, bispecific antibody drug conjugates, fusion protein and nucleic acid drugs, as well as the exploration of next-generation innovative therapies, including cancer and autoimmune diseases. Our product pipelines cover five major therapeutic areas, including malignant tumors, autoimmune diseases, chronic metabolic diseases, neurologic diseases and infectious diseases. A total of four drugs have been commercialized, around 30 assets are undergoing clinical trials, and over 20 drug candidates are at the preclinical drug development stage. In January 2024, Coherus BioSciences, a partner of Junshi Biosciences, announced that toripalimab was available for access and administration in the United States. Prior to this, toripalimab (US trade name: LOQTORZI®) was approved for marketing by the US Food and Drug Administration (the “FDA”) in October 2023, and is the first drug for the treatment of nasopharyngeal carcinoma (“NPC”) in the United States. At present, it is also the only preferred drug recommended in the National Comprehensive Cancer Network (“NCCN”) Clinical Practice Guidelines in Oncology for Head and Neck Cancers 2025.V1 for the treatment of recurrent/ metastatic NPC across all lines.In January 2024, the new drug application (the “NDA”) for toripalimab for the treatment of NPC was accepted by the Singapore Health Sciences Authority (the “HSA”). In March 2025, the NDA for toripalimab (Singapore trade name: LOQTORZI®) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic NPC has been approved by the HSA. Toripalimab has become the first and only approved immuno-oncology treatment for NPC in Singapore.In April 2024, the Japanese Pharmaceuticals and Medical Devices Agency (the “PMDA”) agreed that the company may proceed with a randomized, double-blind, placebo-controlled, international multi-regional phase 3 clinical study of tifcemalimab (a recombinant humanized anti-BTLA monoclonal antibody, code: TAB004/JS004) in combination with toripalimab as consolidation therapy for patients with limited-stage small cell lung cancer (“LS-SCLC”) without disease progression following chemo-radiotherapy.In April 2024, the supplemental new drug application (the “sNDA”) for toripalimab in combination with axitinib for the first-line treatment for patients with medium to high risk unresectable or metastatic renal cell carcinoma (“RCC”) was approved by the National Medical Products Administration of China (the “NMPA”). This is the first approved immunotherapy for renal carcinoma in China.In April 2024, the NDA for toripalimab in combination with cisplatin and gemcitabine for 1) the first-line treatment of adults with metastatic or recurrent locally advanced NPC and 2) 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 was accepted by the Drug Office of the Department of Health, Hong Kong Special Administration Region Government (the “DO”), and was approved by the Pharmacy and Poisons Board of Hong Kong (the “PPB”) in October 2024, making toripalimab the first and only immunotherapy drug for NPC in Hong Kong SAR, China.In June 2024, the primary endpoints of progression-free survival (“PFS”, based on independent radiographic review) and overall survival (“OS”) of a multinational multi-center, randomized, open-label, active controlled phase III clinical study (the HEPATORCH study, NCT04723004) of TUOYI® in combination with bevacizumab for the first-line treatment of advanced hepatocellular carcinoma (“HCC”) met the pre-defined efficacy boundary. The sNDA was accepted by the NMPA in July 2024 and was approved by the NMPA in March 2025.In June 2024, the sNDA for TUOYI® in combination with etoposidein plus platinum as the first-line treatment of extensive-stage small cell lung cancer (“ES-SCLC”) was approved by the NMPA.In June 2024, the sNDA for TUOYI® in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (“TNBC”) with a well-validated test to evaluate PD-L1 positive (CPS ≥ 1) was approved by the NMPA.In July 2024, the investigational new drug (“IND”) application for JS125 (a targeted histone deacetylases (“HDACs”) inhibitor) was accepted by the NMPA and approved in September 2024.In July 2024, a positive opinion was obtained from the Committee for Medicinal Products for Human Use (the “CHMP”) of the European Medicines Agency (the “EMA”) for the marketing authorization application (the “MAA”) of toripalimab (European trade name: LOQTORZI®), which recommended approval for the treatment of two indications: toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic NPC, and toripalimab in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (“ESCC”). In September 2024, this MAA was approved by the European Commission (the “EC”). The approval is applicable to all 27 member states of the European Union (the “EU”), Iceland, Norway and Liechtenstein, making toripalimab the first and only drug for the treatment of NPC and the only first-line treatment for advanced or metastatic ESCC regardless of PD-L1 status in Europe.In August 2024, the sNDA for toripalimab as the first-line treatment for unresectable or metastatic melanoma was accepted by the NMPA.In September 2024 and November 2024, toripalimab was approved for marketing in India and Jordan, respectively, for the treatment of two indications: toripalimab in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent, locally advanced NPC and toripalimab, as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. Toripalimab officially commenced commercial sales in India in 2024.In October 2024, the NDA for ongericimab injection (a recombinant humanized anti-PCSK9 monoclonal antibody injection, trade name: JUNSHIDA) as the treatment for adult patients with primary hypercholesterolemia (non-familial) and mixed dyslipidemia was approved for marketing by the NMPA.In November 2024, toripalimab (UK trade name: LOQTORZI®) obtained the marketing authorisation from the United Kingdom’s (the “UK”) Medicines and Healthcare products Regulatory Agency (the “MHRA”) for the treatment of two indications: toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic NPC, and toripalimab in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC. Toripalimab has become the first and only drug for the treatment of NPC and the only first-line treatment for advanced or metastatic ESCC regardless of PD-L1 status in the UK.In November 2024, four new indications of toripalimab were successfully included in Category B of the National Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (Year 2024) (the “NRDL”). The ten approved indications of toripalimab in the Chinese mainland were all included in the NRDL, and TUOYI® is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of non-small cell lung cancer (“NSCLC”), treatment of renal carcinoma and treatment of TNBC. Update on business operations In June 2024, Junshi Biosciences convened the 2023 annual general meeting, the 2024 first class meeting of A shareholders and the 2024 first class meeting of H shareholders, and completed the election of the fourth session of the Board of Directors and the board of supervisors of the company and other matters.In July 2024, Suzhou Union Biopharm Co., Ltd., a wholly-owned subsidiary of Junshi Biosciences, received the CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER issued by The Ireland Health Products Regulatory Authority (the “HPRA”) in accordance with the relevant regulations of the EMA. This is the first time that the relevant production facilities of toripalimab obtained the GMP certificate of a member state of the EU. According to the GMP mutual recognition system among the EU member states, obtaining the GMP certificate indicates that the production facilities with the certificate have met the GMP standards of the EU.In August 2024, the A shares of Junshi Biosciences (“A Shares”) were included in the SSE STAR Brand Name Drug Index. The index selects 30 securities of companies listed on the STAR Market with the largest market capitalization and engaged in innovative drugs as constituents, reflecting the overall performance of the securities of the companies listed on the STAR Market and engaged in innovative drugs.As of September 2024, the company completed the implementation of the A-Share repurchase plan, with a total of 815,871 A Shares repurchased, accounting for 0.0828% of the total share capital of the company, which will be used for the purpose of share incentives and/or employee stock ownership plan(s) at an appropriate time in the future.In December 2024, the company’s A Shares were included in the CSI A500 Index. The index selects 500 securities with the largest market capitalization and strong liquidity from various sectors as constituents, reflecting the overall performance of the most representative listed companies across different sectors. About Junshi BiosciencesFounded 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. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 35 countries and regions including China, the US, and Europe. 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 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://www.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

Drug ApprovalPhase 3ImmunotherapyFinancial StatementBiosimilar

31 Aug 2024

·www.globenewswire.com

Junshi Biosciences Announces 2024 Interim Financial Results and Provides Corporate Updates

SHANGHAI, Aug. 30, 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 2024 interim financial results and provided corporate updates. FINANCIAL HIGHLIGHTS As of June 30, 2024, the total revenue of Junshi Biosciences was approximately RMB786 million during the first half of 2024, representing an increase of approximately 17% compared to 2023. The growth was mainly due to the approximately 11% increase in revenue from pharmaceutical products compared to 2023. In particular, the domestic sales revenue of our core product, TUOYI® (toripalimab), reached approximately RMB671 million, representing an increase of approximately 50% compared to 2023.Total research and development (“R&D”) expenses were approximately RMB546 million for the first half of 2024, representing a decrease of approximately 42% compared to 2023. The decrease in R&D expenses was mainly due to the company’s cost control policy, efforts to optimize resource allocation and focus on R&D pipelines with greater potential. In addition, several clinical trials for our core product, TUOYI®, successively met their primary endpoints, contributing to the natural decline of R&D expenditure.Loss attributable to owners of the company decreased to RMB646 million for the first half of 2024, representing a decrease of approximately RMB351 million or approximately 35% compared to 2023.As of June 30, 2024, the company’s aggregate balance of bank balances, cash and financial products was approximately RMB3,311 million, a slight decrease of RMB467 million compared to the balance at the end of 2023, which ensured our relatively sufficient cash position to support the company’s development. BUSINESS HIGHLIGHTS During the first half of 2024, we focused on addressing “unmet medical needs”. We have made original, innovative and breakthrough progress in the discovery, R&D and commercialization of innovative therapies and novel drugs with accelerating international development. The following achievements and milestones were reached: Advancements in the pipeline: the company’s innovative R&D field has expanded beyond monoclonal antibodies to a wider range of drug modalities, including small molecules drugs, polypeptide drugs, antibody-drug conjugates (ADCs), bi-specific or multi-specific antibodies and nucleic acid drugs. The company is also exploring 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 currently on the market, around 30 assets are undergoing clinical trials, and over 20 drug candidates are at the pre-clinical drug development stage. In January 2024, the National Drug List for Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance (Year 2023) (the “NRDL”) was officially implemented. Junshi Biosciences has three drugs included in the newest edition of the NRDL. Notably, 3 new TUOYI® indications have been included: first-line treatment of nasopharyngeal carcinoma (“NPC”), first-line treatment of esophageal squamous cell carcinoma (“ESCC”) and first-line treatment of non-squamous non-small cell lung cancer (“NSCLC”), bringing the current number of indications in the NRDL to a total of 6. MINDEWEI’s indication for adult patients with mild to moderate coronavirus disease 2019 (“COVID-19”) was officially included in the NRDL for the first time. All eight approved indications of JUNMAIKANG remain in the NRDL.In January 2024, Coherus BioSciences, Inc. (“Coherus”), a partner of the company, announced that toripalimab was available for access and administration in the United States. Prior to that, toripalimab (U.S. trade name: LOQTORZI®) was approved for marketing by the U.S. Food and Drug Administration (the “FDA”) in October 2023, and became the first innovative biological drug from China included as a preferred treatment option in the NPC guidelines of the National Comprehensive Cancer Network (“NCCN”) in December 2023.In January 2024, the Singapore Health Sciences Authority (the “HSA”) accepted the new drug application (the “NDA”) 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 April 2024, the Japanese Pharmaceuticals and Medical Devices Agency (the “PMDA”) approved the company’s initiation of a randomized, double-blind, placebo-controlled, international multi-regional 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.In April 2024, two supplemental new drug applications (the “sNDA”) for ongericimab (a recombinant humanized anti-PCSK9 monoclonal antibody, code: JS002) were accepted by the National Medical Products Administration of China (the “NMPA”).In April 2024, the NMPA approved the sNDA for TUOYI® in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (“RCC”). This was the first approved immunotherapy for renal carcinoma in China.In April 2024, the NDA 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 was accepted by the Drug Office, Department of Health, the Government of the Hong Kong Special Administration Region (the “DO”).In June 2024, the primary endpoints of progression-free survival (“PFS”, based on independent radiographic review) and overall survival (“OS”) of a multi-center, randomized, open-label, active controlled phase III clinical study (the “HEPATORCH study”, NCT04723004) of TUOYI® in combination with bevacizumab for the first-line treatment of advanced hepatocellular carcinoma (“HCC”) met the pre-defined efficacy boundary, and the sNDA was accepted by the NMPA in July 2024.In June 2024, the NMPA approved the sNDA for TUOYI® in combination with etoposidein plus platinum as the first-line treatment of extensive-stage small cell lung cancer (“ES-SCLC”).In June 2024, the NMPA approved the sNDA for TUOYI® in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (“TNBC”) with a well-validated test to evaluate PD-L1 positive (CPS≥1). This was the 10th indication of toripalimab approved in the Chinese mainland. Business operations As of the end of the first half of 2024, Junshi Biosciences completed the Good Manufacturing Practice (“GMP”) and Good Clinical Practice inspections of the European Union (the “EU”). Currently, the European Commission (the “EC”) is reviewing the marketing authorization applications (the “MAA”) for toripalimab for the first-line treatment of NPC and ESCC.In June 2024, the company convened the 2023 annual general meeting, the 2024 first class meeting of A shareholders and the 2024 first class meeting of H shareholders, and completed the election for the fourth session of the Board of Directors and the Board of Supervisors. 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 2,500 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

Drug ApprovalPhase 3Financial StatementImmunotherapyClinical Result

29 Mar 2024

·www.biospace.com

Junshi Biosciences Announces 2023 Full Year Financial Results and Provides Corporate Updates

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

License out/inDrug ApprovalOrphan DrugPhase 3Financial Statement

100 Deals associated with Tifcemalimab

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Classical Hodgkin's Lymphoma	Phase 3	China	Shanghai Junshi Biosciences Co., Ltd.	28 Dec 2023
Refractory Classic Hodgkin Lymphoma	Phase 3	China	Shanghai Junshi Biosciences Co., Ltd.	28 Dec 2023
Extensive stage Small Cell Lung Cancer	Phase 3	United States	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023
Extensive stage Small Cell Lung Cancer	Phase 3	China	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023
Extensive stage Small Cell Lung Cancer	Phase 3	Netherlands	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023
Extensive stage Small Cell Lung Cancer	Phase 3	Spain	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023
Extensive stage Small Cell Lung Cancer	Phase 3	Taiwan Province	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023
Extensive stage Small Cell Lung Cancer	Phase 3	Turkey	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023
Small cell lung cancer limited stage	Phase 3	United States	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023
Small cell lung cancer limited stage	Phase 3	China	Shanghai Junshi Biosciences Co., Ltd.	15 Nov 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05664971 (WCLC2025) Manual	Phase 1/2	Extensive stage Small Cell Lung Cancer First line	44	Tifcemalimab 200 mg + Toripalimab 240 mg + Chemotherapy	fjcsfnelpa(edsdjksvuf) = ooktknnenl rxfkyvrpsy (ylbdfmajcn ) View more	Positive	09 Sep 2025
NCT05664971 (ESMO_ASIA2024) Manual	Phase 1/2	Squamous non-small cell lung cancer Second line	41	Tifcemalimab 200 mg + Toripalimab 240 mg + Docetaxel 75 mg/m2	czggcrstju(oxrkfocyuy) = kobopukuxo fnwkgtrbfa (eryxtkdymz ) View more	Positive	07 Dec 2024
NCT05000684 (WCLC2024) Manual	Phase 1/2	Extensive stage Small Cell Lung Cancer PD-L1 \| HVEM positive	43	Tifcemalimab 200mg + Toripalimab 240mg	omodhyciav(vkjisremrz) = ssyisfgarq bvvhutogfk (lxywqmyjpi ) View more	Positive	10 Sep 2024
NCT04137900 (ASCO2024) Manual	Phase 1	Advanced cancer	85	Tifcemalimab 2toripalimab	nghstoodaf(mvszpvkrhf) = bzhglvdymj zmyzexljlt (xmnobzihqv ) View more	Positive	24 May 2024
				Tifcemalimab 7toripalimab	vjrtzqqsgv(izgnuqkwrw) = korqyyszyp dxrsbkumqh (tsemwjleuv ) View more
NCT05664971 (ASCO2024) Manual	Phase 1/2	Extensive stage Small Cell Lung Cancer First line \| Maintenance	44	Tifcemalimab 200mg + Toripalimab 240mg + Chemotherapy	qvrwixbgty(chfzmilshg) = xkolnslooj enklplfxgy (kiadcwnypm ) View more	Positive	24 May 2024
				Tifcemalimab 200mg + Toripalimab 240mg + Chemotherapy (patients with PD-L1 positive expression)	qvrwixbgty(chfzmilshg) = ovxadbysaa enklplfxgy (kiadcwnypm )
NCT05000684 (ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	Extensive stage Small Cell Lung Cancer	43	tifcemalimab+Toripalimab	urpxuiswpz(vauvgrehij) = vakmtkxsnp bhamxnngrd (dzxpabwzsn ) View more	Positive	26 May 2023
				tifcemalimab+Toripalimab (immunotherapy treated patients)	cgbelwksjv(bioyvbqhhu) = zyekuhefql xzxagaembo (qllbdudyoz )
NCT04477772 (ASH 12022 \| ASH 22022) Manual	Phase 1	Lymphoma	48	Tifcemalimab	uwvcsopdla(scgqlkgpzk) = ststkuikbk qnvaubfvrg (vdcdtqoovx ) View more	Positive	15 Nov 2022
				Tifcemalimab+Toripalimab	uwvcsopdla(scgqlkgpzk) = xcasfnjqtp qnvaubfvrg (vdcdtqoovx ) View more
NCT04477772 (Corporate Publications) Manual	Phase 1	Classical Hodgkin's Lymphoma	12	Toripalimab+Tifcemalimab	alklrjqdlv(vxkqmicels) = aitfyidlpn yljcoxvguc (xztugujtrj ) View more	Positive	30 Aug 2022
NCT04477772 (ASCO2022) Manual	Phase 1	Lymphoma	31	icatolimab (monotherapy dose escalation)	wiuryxdiai(fpyckxwdja) = 6 (19.4%) experienced, the most common TEAEs were anemia (29.0%) and fever (22.6%) lotyftqhhn (rhrkjeexgd ) View more	Positive	02 Jun 2022
				Toripalimab+icatolimab (combination dose escalation)
NCT04137900 (ASCO2022)	Phase 1	Advanced Malignant Solid Neoplasm	25	Icatolimab 0.3 mg/kg	fbxmofllzm(ksohgiqtmf) = 24 (96%) patients experienced treatment emergent adverse event (TEAEs), with 7 (28%) experienced grade 3 TEAEs. No grade 4 or 5 TEAE occurred. The incidence or severity of AE was not associated with the dose. The most common TEAEs were fatigue (32%), abdominal pain (20%), diarrhea (16%), arthralgia (16%), aspartate aminotransferase increased (16%), constipation (16%), and contusion (16%). One (4%) TEAE led to discontinuation of study drug. Four (16%) patients experienced immune related AE. fiqicbyfkb (bzvwcuugps )	Positive	02 Jun 2022
				Icatolimab 1 mg/kg

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