CStone Pharmaceuticals

What CStone Pharmaceuticals does

CStone Pharmaceuticals (基石药业) is a biopharmaceutical company founded in late 2015 and listed on the Hong Kong Stock Exchange (HKEX: 2616), headquartered in Suzhou, China. The company develops innovative oncology therapies and is expanding into immunology and inflammation, with four commercialized drugs (sugemalimab/择捷美, pralsetinib/普吉华, avapritinib/泰吉华) and a clinical pipeline that includes the first-in-class PD-1/VEGF/CTLA-4 trispecific antibody CS2009 and three ADC candidates (CS5007, CS5006, CS5008) built on a proprietary CSL20 linker with exatecan payload platform. The technology foundation combines the licensed OmniRat transgenic animal platform for fully human antibody generation with proprietary ADC chemistry and trispecific antibody engineering, and the company has secured regulatory approvals across China NMPA, EU EC, UK MHRA, and FDA.

CStone operates a dual-track go-to-market model: direct sales and partner-led commercialization in China for approved products, paired with exclusive licensing and commercialization partnerships for international markets across Europe, Latin America, the Middle East, Africa, and Oceania — covering over 60 countries through five strategic partnerships, including Pfizer for China, Shanghai Allist for pralsetinib in China, Blueprint Medicines (now Sanofi) as the originator licensor for pralsetinib, and Arrotex Pharmaceuticals for Australia/New Zealand. Revenue is generated through domestic product sales of sugemalimab, pralsetinib, and avapritinib, supplemented by upfront payments, regulatory and commercial milestone payments, and profit-share arrangements from international partners. FY2025 revenue was RMB 269.6 million with a net loss of RMB 437.0 million, reflecting the early commercial stage and continued investment in pipeline development.

The end customers are cancer patients and the healthcare providers who treat them, addressing unmet medical needs across NSCLC, gastric cancer, esophageal squamous cell carcinoma, extranodal NK/T-cell lymphoma, GIST, thyroid cancer, and other oncology indications. The company is led by CEO and President of R&D Jason Yang (杨建新) and Chief Medical Officer Qingmei Shi (史青梅), with FY2025 results showing pipeline catalysts across sugemalimab European expansion (UK MHRA Stage III NSCLC approval in February 2026), pralsetinib NRDL-driven domestic growth (over 430% YoY volume increase), CS2009 FDA IND clearance and ASCO 2026 data presentation, and CS5007 global Phase I initiation — supported by HK$468 million and approximately USD 134 million equity placements in 2025 and 2026 respectively.

Name

CStone Pharmaceuticals

Legal name

CStone Pharmaceuticals

Website

https://cstonepharma.com

Company type

Public

Founded year

2015

Operating status

Operating

Headcount range

101–250 employees

Short description

CStone Pharmaceuticals is a China-headquartered, Hong Kong-listed biopharmaceutical company developing innovative oncology therapies, with four commercialized drugs (sugemalimab, pralsetinib, avapritinib) and a clinical-stage pipeline of trispecific antibodies and ADCs targeting cancer patients globally through direct sales in China and licensing partnerships across 60+ countries.

Ownership category

akta.pro rank

Product category

Oncology Biopharmaceuticals

NAICS

Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Oncology Specialty Pharmaceuticals (HLAIACAA)

akta.pro secondary industries

Oncology & Hematology Pharmaceuticals (HLAIAAAC), Specialty Care Pharmaceuticals (HLAIAAAB)

Keywords

• Oncology drug development
• Immunotherapy treatments
• Antibody drug conjugates
• Precision medicine oncology
• Biopharmaceutical research

Headquarters

HQ city

Suzhou

HQ country

China

HQ region

Asia

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales

Revenue model

1. Product Sales (Domestic China): Revenue from commercialized products including sugemalimab (舒格利单抗), pralsetinib (普拉替尼), avapritinib (阿伐替尼), and other approved drugs sold in China through direct sales and distribution partnerships.
2. Partnership and Licensing Revenue: Revenue from upfront payments, regulatory milestones, commercial milestones, and profit sharing arrangements from international commercialization partners for sugemalimab and other pipeline products across global markets.
3. Financing Activities: Capital raised through equity placements. In H1 2025, CStone completed an HK$468 million placement as part of financing activities.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels5 records

Core offering

CStone Pharmaceuticals is an innovation-driven biopharmaceutical company that discovers, develops, and commercializes innovative oncology, immunology, and inflammation drugs. The company sells four approved innovative drugs and advances a pipeline of 16 candidates including antibody-drug conjugates, multispecific antibodies, immunotherapies, and precision medicines targeting cancers such as NSCLC, colorectal cancer, GIST, thyroid cancer, and lymphoma.

Product overview

CStone Pharmaceuticals is a biopharmaceutical company with four commercialized products: sugemalimab (anti-PD-L1 antibody), pralsetinib (RET inhibitor), and avapritinib (GIST treatment), plus one clinical-stage asset CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody in Phase II/III). The Pipeline 2.0 includes three ADC candidates (CS5007, CS5006, CS5008) in various development stages. The company operates through a network of regional commercialization partners for international markets.

Differentiator

Problem solved

Functional benefit

Products and services

• Sugemalimab (择捷美®) A fully human, full-length anti-PD-L1 IgG4 monoclonal antibody developed using the OmniRat transgenic animal platform; approved in EU, UK, and China for multiple NSCLC indications and other cancer types, and commercialized globally through five strategic partnerships.
• Pralsetinib (普吉华®/GAVRETO®) Oral, once-daily highly selective RET inhibitor for treating RET fusion-positive NSCLC and thyroid cancer; in-licensed from Blueprint Medicines and commercialized in China by Shanghai Allist Pharmaceuticals, with domestic manufacturing approved in 2026.
• Avapritinib (泰吉华®/AYVAKIT®) Kinase inhibitor for treating PDGFRA exon 18 mutation-positive gastrointestinal stromal tumors (GIST), including PDGFRA D842V mutation; approved in China, US, EU, Taiwan, and Hong Kong.
• CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody) First-in-class trispecific antibody targeting PD-1, VEGF, and CTLA-4 for cancer immunotherapy, with differentiated CTLA-4 module design minimizing systemic immune toxicity while preserving CTLA-4 immune activation. Demonstrated 81.3% ORR in first-line NSCLC with Grade ≥3 TRAE of 5.1%; Phase II ongoing with global Phase III MRCT planned by end of 2026.
• CS5007 (EGFR/HER3 Bispecific ADC) Bispecific antibody-drug conjugate targeting EGFR and HER3 with proprietary CSL20 linker and exatecan payload; designed to overcome resistance mechanisms in single-target EGFR therapies by blocking both receptors and downstream signaling. Global Phase I initiated in 2026.
• CS5006 (ITGB4 ADC) Antibody-drug conjugate targeting ITGB4 for solid tumors, leveraging the proprietary CSL20 linker/exatecan payload platform; IND filing planned for H2 2026.
• CS5008 (DLL3/SSTR2 Bispecific ADC) Bispecific antibody-drug conjugate targeting DLL3 and SSTR2 for small cell lung cancer and neuroendocrine tumors; IND filing planned for H2 2026.
• CS2015 (OX40L/TSLP Bispecific Antibody) Bispecific antibody targeting OX40L and TSLP for autoimmune and inflammatory diseases, expanding CStone's therapeutic focus beyond oncology.

Quantifiable outcome

• CS2009 achieved 81.3% ORR and 100% DCR in first-line NSCLC monotherapy (PD-L1 TPS ≥50%)
• +4 more outcomes

Named customers1 record

Segments1 record

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Eight partnerships are on record, tiered core and minor.

• Arrotex PharmaceuticalscoreChannel Partner/ Reseller/ Distributor · 25 June 2026Exclusive commercialization agreement for sugemalimab in Australia and New Zealand. CStone receives upfront payment plus regulatory and commercial milestone payments, supplies the drug, and receives profit share. Arrotex handles registration, market access, and commercialization for all approved and future indications including NSCLC, gastric cancer, ESCC, and ENKTL.
• Shanghai Allist PharmaceuticalscoreChannel Partner/ Reseller/ Distributor · 1 November 2023Exclusive commercialization agreement for pralsetinib capsules in Mainland China. Shanghai Allist is responsible for commercializing pralsetinib in the Chinese domestic market.
• Ligand PharmaceuticalscoreTechnology or Integration · 30 September 2020Licensed OmniRat transgenic animal platform from Ligand for development of fully human antibodies including sugemalimab. Platform enables one-step generation of fully human antibodies.
• SteinCaresminorChannel Partner/ Reseller/ DistributorSugemalimab commercialization partnership covering Latin America region.
• GentiliminorChannel Partner/ Reseller/ DistributorSugemalimab commercialization partnership as part of the five global strategic partnerships for the product.
• PfizercoreStrategic or Co-development PartnerStrategic collaboration including development and commercialization of sugemalimab in China, with Pfizer providing commercial support and expertise in the Chinese pharmaceutical market.
• VeristatminorImplementation/ SI/ Consulting PartnerGlobal CRO and consultancy supporting CStone in navigating regional regulatory requirements and securing approvals for international market entry into Europe, UK, Australia, Canada, and US.
• DBG HealthcoreChannel Partner/ Reseller/ DistributorParent company of Arrotex Pharmaceuticals, Australia's largest diversified healthcare group. Arrotex is the core pharmaceutical commercialization platform of DBG Health.

Scale indicators9 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• BeiGene: China-based oncology-focused biopharmaceutical company with a deep pipeline of small molecules and biologics, including the PD-1 antibody tislelizumab. Direct competitor to CStone in oncology biologics with global commercial reach, similar Beijing-headquartered structure, and HKEX/NASDAQ dual listing.
• Innovent Biologics: Chinese biotech developing innovative oncology biologics including PD-1 inhibitor sintilimab and multiple ADCs and bispecific antibodies. Closely comparable in therapeutic focus (oncology biologics), pipeline breadth, China commercial infrastructure, and HKEX-listed public company profile.
• Akeso, Inc. Chinese biotech specializing in bispecific and multispecific antibodies for oncology and immunology, including the PD-1/VEGF bispecific ivonescimab. Directly comparable to CStone's CS2009 trispecific approach and oncology biologics pipeline focus.
• Junshi Biosciences: Chinese biotech that developed toripalimab, the first domestically approved PD-1 antibody in China. Comparable as a Chinese innovator biotech with PD-1/immunology focus, HKEX/A-share listed, and similar global out-licensing strategy.
• Hutchmed (China) Limited: Hong Kong and London-listed Chinese oncology and immunology biotech with multiple commercialized targeted therapies (surufatinib, fruquintinib) and global partnerships. Comparable as a Chinese innovator pharma with HKEX listing, oncology focus, and out-licensing-driven model.
• RemeGen Co., Ltd. Chinese biotech developing antibody-drug conjugates and bispecific antibodies for cancer and autoimmune diseases. Comparable to CStone in ADC pipeline focus, novel biologics platform approach, and HKEX-listed public company status.
• Legend Biotech: Clinical-stage Chinese biotech with global CAR-T franchise (carvykti partnership with Janssen). Comparable as a Chinese-origin oncology biotech with deep clinical pipeline, NASDAQ/HKEX dual listing, and major partnership-driven commercialization model.

Broad incumbents

• Sino Biopharmaceutical Limited: One of China's largest pharmaceutical conglomerates with a broad oncology and specialty care portfolio. Comparable as a HKEX-listed Chinese pharma company with significant oncology presence, but much larger scale and more diversified across therapeutic areas.
• Hansoh Pharmaceutical Group: Large Chinese pharmaceutical company with substantial oncology franchise including innovative small molecules and biologics. Comparable in oncology focus and HKEX-listed Chinese innovator pharma positioning, though broader and more established than CStone.

Emerging players

• Genor Biopharma: Hong Kong-listed Chinese oncology biotech with focus on immuno-oncology and bispecific antibodies. Comparable as a smaller, earlier-stage Chinese oncology innovator with HKEX listing and biologics pipeline focus.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds5 records

Investors12 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about CStone Pharmaceuticals