The company was founded in December 2012 and is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies. With excellent innovative drug discovery capabilities, advanced biotechnology research and development, large-scale production technology throughout the entire industry chain, and a combination of drugs under development with great market potential, the company has great potential in tumor immunotherapy, as well as treatment of autoimmune diseases, chronic metabolic diseases, neurological diseases, and infectious diseases. The company's main business is the discovery and development of innovative drugs, as well as clinical research and commercialization on a global scale. The company's main products are mainly biological products innovated at the source and independently developed. Corporate honors: “Zhangjiang Star” Leading Enterprise in the Zhangjiang National Independent Innovation Demonstration Zone”, “Leading Power: High-Quality Chinese Pharmaceutical Development Achievement Enterprise (2022)”, “High Quality Development of the Big Health Industry - Excellent Case of Informatization”, etc.
Clinical Trials
67
12 active
Approvals
6
Total approvals
Agencies
1
Regulatory bodies
Founded
2012
Active, not recruiting
8
11.9%
Completed
2
3.0%
Not yet recruiting
4
6.0%
Recruiting
18
26.9%
Unknown
35
52.2%
- Junshi Biosciences has entered a licensing agreement with Fosun Wanbang for roconkibart (JS005), an anti-IL-17A monoclonal antibody, covering development, registration, manufacturing, and commercialization across Greater China. - Junshi will receive an upfront payment of RMB 215 million, with additional milestone payments of up to RMB 1.125 million and double-digit tiered royalties on net sales. - Roconkibart's Phase 3 trial in moderate-to-severe plaque psoriasis demonstrated a 91% PASI 90 response rate at week 16 and a 65% PASI 100 response rate at week 52 in the 150 mg dosing group. - The NDA for roconkibart in moderate-to-severe plaque psoriasis was accepted by the NMPA in December 2025, and Phase 2 follow-up for ankylosing spondylitis has been completed.
- Storm Therapeutics raised $56 million in Series C funding from investors including Pfizer Ventures, Taiho Ventures, and Fast Track Initiative to advance STC-15, a first-in-class METTL3 inhibitor. - The company has dosed the first patient in a Phase II monotherapy study evaluating STC-15 in select sarcoma subtypes, with plans for a combination study with toripalimab. - STC-15 demonstrated durable tumor regression across multiple sarcoma subtypes in Phase I trials by targeting METTL3, an RNA-modifying enzyme critical for cancer stem cell differentiation. - The Phase II study is designed to support a potential accelerated regulatory approval pathway for STC-15 and establish foundation for development in additional oncology indications.
- China's National Medical Products Administration has accepted new drug applications for JS001sc, the first domestic anti-PD-1 monoclonal antibody in subcutaneous formulation to reach marketing application stage. - The application covers 12 tumor indications and is supported by a Phase 3 clinical study demonstrating non-inferior drug exposure compared to intravenous administration with comparable efficacy and safety. - The subcutaneous formulation addresses urgent clinical needs for more convenient immunotherapy administration, potentially reducing dosing time and improving patient treatment experiences across multiple cancer types.
- Toripalimab plus chemotherapy demonstrated unprecedented 5-year survival benefits in nasopharyngeal carcinoma, achieving a median overall survival of 64.8 months and 52.3% five-year survival rate. - The anti-PD-1 antibody showed sustained efficacy in esophageal squamous cell carcinoma with a median overall survival of 17.7 months and 29.7% three-year survival rate. - These results from JUPITER-02 and JUPITER-06 trials establish new treatment standards, with toripalimab now approved in over 40 countries for these indications. - Researchers developed the world's first Esophageal Genomic Immunophenotype Classification to guide personalized treatment strategies for patients with poor chemo-immunotherapy response.
- Junshi Biosciences announced that JS005, an anti-IL-17A monoclonal antibody, successfully met both co-primary endpoints and key secondary endpoints in a Phase 3 trial for moderate to severe plaque psoriasis. - The multi-center, randomized, double-blind, placebo-controlled study conducted across 60 clinical sites in China demonstrated statistically significant and clinically meaningful improvements in PASI 90 and sPGA scores at Week 12. - The company plans to submit a new drug application to regulatory authorities in the near future, potentially offering a new treatment option for the approximately 125 million psoriasis patients worldwide. - JS005 works by binding to IL-17A with high affinity and selectively blocking its interaction with receptors, thereby inhibiting downstream inflammatory pathways associated with autoimmune diseases.
- TREOS Bio has initiated OBERTO-202, a potentially registration-enabling Phase II trial evaluating PolyPEPI1018 combined with toripalimab and standard care in 140 patients with microsatellite stable metastatic colorectal cancer. - The study targets the 85% of colorectal cancer cases that show limited response to current immunotherapies, representing approximately 130,000 new US patients annually. - PolyPEPI1018 has demonstrated encouraging clinical activity across three Phase I/II trials involving 44 patients, with consistent correlations between immune activation and clinical benefit. - The company secured $2.1 million in bridge financing to support the trial initiation, bringing total funding to $47 million.
- China's National Healthcare Security Administration has officially established an initial pricing mechanism for newly launched drugs, marking a shift from cost-control to innovation-encouraging healthcare policies. - The mechanism allows high-quality innovative drugs to achieve "returns commensurate with high investment and high risk" with satisfactory price levels and five-year price stability periods. - Over 100 new price items for medical technologies including brain-computer interfaces have been added, facilitating faster clinical adoption and revenue generation for breakthrough technologies. - The policy addresses the long-standing challenge where innovative drugs faced significant price reductions to enter medical insurance coverage, severely dampening pharmaceutical innovation enthusiasm.
• China's NMPA has approved Junshi Biosciences' IND application for JS212, a first-in-class bispecific antibody-drug conjugate simultaneously targeting EGFR and HER3 in various tumor types. • The dual-targeting mechanism of JS212 potentially offers advantages over traditional single-target ADCs, including broader efficacy across multiple cancers and reduced risk of drug resistance. • BioDlink, a global CDMO with specialized ADC expertise, provided comprehensive development and manufacturing support for the technically complex bispecific ADC candidate.
- Toripalimab, an anti-PD-1 monoclonal antibody, has been approved in Australia for the treatment of nasopharyngeal carcinoma (NPC). - The approval covers first-line treatment in combination with chemotherapy and as a single agent for recurrent or metastatic NPC after platinum-based chemotherapy. - This marks toripalimab as the first and only immuno-oncology treatment option available for NPC patients in Australia. - The approval was based on data from the JUPITER-02 and POLARIS-02 trials, demonstrating improved survival and antitumor activity.
• Moderna and Merck's mRNA-4157 combined with pembrolizumab significantly reduced melanoma recurrence risk by 44% compared to pembrolizumab alone, marking a leap in personalized cancer treatment. • Nivolumab combined with chemotherapy showed a 92% two-year progression-free survival rate in advanced Hodgkin lymphoma, offering a safer, more effective treatment option. • Junshi Biosciences' toripalimab, combined with chemotherapy, significantly improved survival in extensive-stage small cell lung cancer, establishing a new first-line treatment. • Eli Lilly's retatrutide demonstrated up to 82% liver fat reduction in patients with metabolic dysfunction-associated steatotic liver disease (MASLD), showcasing potential in liver disease treatment.
