Junshi Biosciences

君实生物

1877.HKbiotechShanghai

Trials 50

Subs 0

People 1

Links 2

Executive Summary

Junshi Biosciences is a Shanghai-based oncology biotech that achieved a major milestone as the first Chinese company to secure FDA approval for a domestically-developed PD-1 antibody (toripalimab/LOQTORZI) in 2023. The company demonstrates strong deal-making capability through its successful partnership with Coherus BioSciences for US commercialization, indicating openness to strategic partnerships. With clear BIOSECURE status and proven regulatory success in both China and the US, Junshi represents a lower-risk opportunity for US pharma partnerships. The company's focus on immuno-oncology and successful navigation of FDA approval processes makes it an attractive potential partner for US BD teams seeking China-originated assets.

Structure: Junshi operates as a Hong Kong-listed entity (1877.HK) with headquarters in Shanghai, suggesting a standard offshore holding company structure typical of Chinese biotechs accessing international capital markets. The company's clear BIOSECURE status and successful FDA interactions indicate a structure designed for international partnerships and regulatory compliance. No complex subsidiary information is available, suggesting a relatively streamlined corporate organization.

Key People

Name	Title	Education	Flags
Jun Xiong 熊俊	Co-founder & CEO	MBA, CEIBS

Ownership & Shareholder Structure

—

Junshi Biosciences → Eli Lilly

deal_partner

Junshi toripalimab partnership — Lilly distributes in China.

—

Junshi Biosciences → Innovent Biologics

competitor

Both have PD-1 antibodies. Toripalimab vs sintilimab. Direct Chinese oncology market competition.

Corporate Events

RST

2023-10-27restructuring

FDA approves toripalimab (LOQTORZI)

Toripalimab became the first China-originated PD-1 antibody approved by FDA. For nasopharyngeal carcinoma. Partnered with Coherus for US launch.

Clinical Trials(50 total)

Phase 3

Phase 2

Phase 1

Phase 1, Phase 2

NCT ID	Interventions	Phase	Status	Enrollment
NCT07040228	Regorafenib combined with Toripalimab and Albumin paclitaxel	Ph.1, Ph.2	RECRUITING	23
NCT05798845	SBRT+LDRT, Toripalimab, Chemotherapy drug, Toripalimab	Ph.2	RECRUITING	124
NCT06732973	JS005	Ph.1	COMPLETED	272
NCT06250062	Recombinant humanized IL-17A Monoclonal Antibody（JS005）, Placebo（JS005）	Ph.2	UNKNOWN	261
NCT06095583	Tifcemalimab injection, toripalimab injection, Placebo for Tifcemalimab, Placebo for toripalimab	Ph.3	RECRUITING	756
NCT05342194	Toripalimab, Lenvatinib mesylate capsules, Placebo IV, Oral placebo, Oxaliplatin for injection, Gemcitabine hydrochloride, Cisplatin	Ph.3	RECRUITING	480
NCT05859529	JS002	Ph.1	COMPLETED	318
NCT06158737	JS010 injection, Placebo	Ph.1	UNKNOWN	48
NCT05757492	CHS-006 (anti-TIGIT), toripalimab (anti-PD-1)	Ph.1	TERMINATED	22
NCT05800340	Toripalimab, Nab paclitaxel, Pemetrexed, Carboplatin	Ph.2	RECRUITING	30
NCT05664971	Recombinant humanized anti-BTLA monoclonal antibody (JS004) injection, Toripalimab, Docetaxel, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel, Etoposide	Ph.1, Ph.2	COMPLETED	119
NCT05770310	JS015	Ph.1	UNKNOWN	114
NCT05751486	Toripalimab injection(subcutaneous)/JS001sc, Toripalimab injection(subcutaneous)/JS001sc, Toripalimab /JS001, Toripalimab injection(subcutaneous)/JS001sc	Ph.1	UNKNOWN	24
NCT06065813	Toripalimab, Conventional segmental radiotherapy, opreation	Ph.2	RECRUITING	20
NCT05388279	JS012, JS012 combine with chemotherapy	Ph.1	TERMINATED	3
NCT05262842	JS001+IMP4297	Ph.1	WITHDRAWN	0
NCT05296772	JS014, Interleukin 21 and humanized anti-human serum albumin VHH antibody, Pembrolizumab - anti-PD-1 antibody	Ph.1	UNKNOWN	60
NCT05532800	JS002, Placebo	Ph.3	COMPLETED	255
NCT05242588	JS005, Placebo	Ph.2	UNKNOWN	120
NCT05325203	Ongericimab, Placebo	Ph.3	COMPLETED	135

Showing 20 of 50 trials

Drug Molecules (ChEMBL)

TORIPALIMAB

Phase 4

AntibodyCHEMBL4297843Approved 2023

Top Publications (by citations)

Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial.

371 citationsCancer Cell2022

Wang ZX, Cui C, Yao J, Zhang Y, Li M, Feng J, Yang S, Fan Y, Shi J, Zhang X, Shen L, Shu Y, Wang C, Dai T, Mao T, Chen L, Guo Z, Liu B, Pan H, Cang S, Jiang Y, Wang J, Ye M, Chen Z, Jiang D, Lin Q, Ren W, Wang J, Wu L, Xu Y, Miao Z, Sun M, Xie C, Liu Y, Wang Q, Zhao L, Li Q, Huang C, Jiang K, Yang K, Li D, Liu Y, Zhu Z, Chen R, Jia L, Li W, Liao W, Liu HX, Ma D, Ma J, Qin Y, Shi Z, Wei Q, Xiao K, Zhang Y, Zhang Y, Chen X, Dai G, He J, Li J, Li G, Liu Y, Liu Z, Yuan X, Zhang J, Fu Z, He Y, Ju F, Liu Z, Tang P, Wang T, Wang W, Zhang J, Luo X, Tang X, May R, Feng H, Yao S, Keegan P, Xu RH, Wang F.

Safety, efficacy and tumor mutational burden as a biomarker of overall survival benefit in chemo-refractory gastric cancer treated with toripalimab, a PD-1 antibody in phase Ib/II clinical trial NCT02915432.

364 citationsAnn Oncol2019

Wang F, Wei XL, Wang FH, Xu N, Shen L, Dai GH, Yuan XL, Chen Y, Yang SJ, Shi JH, Hu XC, Lin XY, Zhang QY, Feng JF, Ba Y, Liu YP, Li W, Shu YQ, Jiang Y, Li Q, Wang JW, Wu H, Feng H, Yao S, Xu RH.

Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial.

301 citationsNat Med2021

Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, Li J, Shi YR, Jin F, Xu R, Pan J, Qu S, Li P, Hu C, Liu YC, Jiang Y, He X, Wang HM, Lim WT, Liao W, He X, Chen X, Liu Z, Yuan X, Li Q, Lin X, Jing S, Chen Y, Lu Y, Hsieh CY, Yang MH, Yen CJ, Samol J, Feng H, Yao S, Keegan P, Xu RH.

Roles of tumor-associated macrophages in anti-PD-1/PD-L1 immunotherapy for solid cancers.

266 citationsMol Cancer2023

Zhang H, Liu L, Liu J, Dang P, Hu S, Yuan W, Sun Z, Liu Y, Wang C.

Perioperative Toripalimab Plus Chemotherapy for Patients With Resectable Non-Small Cell Lung Cancer: The Neotorch Randomized Clinical Trial.

254 citationsJAMA2024

Lu S, Zhang W, Wu L, Wang W, Zhang P, Neotorch Investigators, Fang W, Xing W, Chen Q, Yang L, Mei J, Tan L, Sun X, Xu S, Hu X, Yu G, Yu D, Yang N, Chen Y, Shan J, Xing L, Tian H, Zhang X, Zhou M, Fang H, Wu G, Liu Y, Ye M, Cao L, Jiang J, Li X, Zhu L, Li S, Kang M, Zhong A, Chen K, Wu N, Sun Q, Ma H, Cai K, Wang C, Lin G, Zhu K, Zhang Y, Zhang X, Hu H, Zhang W, Chen J, Yang Z, Hang X, Hu J, Huang Y, Zhang Z, Zhang L, Zhang L, Liu L, Lin D, Zhang J, Chen G, Li Y, Zhu L, Wang W, Yu W, Cao D, Keegan P, Yao S.

Efficacy, Safety, and Correlative Biomarkers of Toripalimab in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (POLARIS-02).

254 citationsJ Clin Oncol2021

Wang FH, Wei XL, Feng J, Li Q, Xu N, Hu XC, Liao W, Jiang Y, Lin XY, Zhang QY, Yuan XL, Huang HX, Chen Y, Dai GH, Shi JH, Shen L, Yang SJ, Shu YQ, Liu YP, Wang W, Wu H, Feng H, Yao S, Xu RH.

Antibodies to watch in 2022.

245 citationsMAbs2022

Kaplon H, Chenoweth A, Crescioli S, Reichert JM.

Targeting cytokine and chemokine signaling pathways for cancer therapy.

241 citationsSignal Transduct Target Ther2024

Yi M, Li T, Niu M, Zhang H, Wu Y, Wu K, Dai Z.

Neoadjuvant PD-1 blockade with toripalimab, with or without celecoxib, in mismatch repair-deficient or microsatellite instability-high, locally advanced, colorectal cancer (PICC): a single-centre, parallel-group, non-comparative, randomised, phase 2 trial.

214 citationsLancet Gastroenterol Hepatol2022

Hu H, Kang L, Zhang J, Wu Z, Wang H, Huang M, Lan P, Wu X, Wang C, Cao W, Hu J, Huang Y, Huang L, Wang H, Shi L, Cai Y, Shen C, Ling J, Xie X, Cai Y, He X, Dou R, Zhou J, Ma T, Zhang X, Luo S, Deng W, Ling L, Liu H, Deng Y.

Antibodies to watch in 2023.

204 citationsMAbs2023

Kaplon H, Crescioli S, Chenoweth A, Visweswaraiah J, Reichert JM.

BIOSECURE Risk

low

Company has clear BIOSECURE status and is not designated under BCC categories, indicating low regulatory risk for US partnerships

Key Exposures:

•Headquarters in Shanghai may require ongoing monitoring of US-China regulatory developments
•Standard China exposure through operational base

Mitigation: Clear BIOSECURE status suggests company has already addressed key compliance requirements; successful FDA approval and US partnership demonstrates regulatory sophistication

BD Intelligence

Pipeline Strength8/10

Deal Readiness9/10

Therapeutic Areas:

Immuno-oncologyPD-1 inhibitorsNasopharyngeal carcinoma

Recent Deals: Successfully partnered with Coherus BioSciences for US commercialization of toripalimab, demonstrating active out-licensing strategy and deal execution capability

Approach: Approach with high priority given proven FDA success and demonstrated partnership willingness; focus on additional pipeline assets beyond toripalimab and potential co-development opportunities

Red Flags

⚠Limited visibility into pipeline beyond toripalimab
⚠Dependence on single major asset for international presence
⚠Standard China operational risks despite clear BIOSECURE status

Quick Facts

Key People: 1
Subsidiaries: 0
CDMO/CRO Subs: 0
Genomics Subs: 0
Direct BIOSECURE: 0
Corp Events: 1
Gov-Connected: 0
Clinical Trials: 50
Publications: 10
Drug Molecules: 1
Relationships: 2

Sources & Methodology

Clinical trials data: ClinicalTrials.gov API v2 (50 trials linked to this entity)

SEC BIOSECURE filings: EDGAR EFTS full-text search (850+ filings from 230 companies)

Publications: Europe PMC API (10 publications indexed)

Drug molecules: ChEMBL database (European Bioinformatics Institute)

Financial data: East Money (东方财富) datacenter API / CNINFO (巨潮资讯网)

Corporate structure: Company official filings, HKEX/SSE/SZSE disclosures

Executive profiles: Company official biographies, SEC filings, LinkedIn (where verified)

Data is collected from public sources and updated weekly. Corporate intelligence is verified by a native Mandarin-speaking analyst against Chinese-language primary sources including Tianyancha (天眼查), GSXT (国家企业信用信息公示系统), and CNINFO (巨潮资讯网). This is not financial or legal advice.