Kelun Biotech

What Kelun Biotech does

Kelun Biotech (Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., 6990.HK) is a Chengdu-based biopharmaceutical company founded in 2016 as a controlled subsidiary of Sichuan Kelun Pharmaceutical (002422.SZ) and listed on the Hong Kong Stock Exchange Main Board in July 2023, with the "B" marker removed in April 2026. The company focuses on the discovery, development, manufacturing, and commercialization of innovative biologics and small molecules in oncology, autoimmune disease, and metabolic disease. Its proprietary OptiDC™ integrated antibody-drug conjugate (ADC) and novel conjugate drug platform — one of the first in China and one of few globally — is supported by three additional technology platforms: a Large Molecule (mAb/bsAb) Platform, an AI-Driven Drug Design (AIDD) Small Molecule Platform, and a Translational Medicine Platform. These platforms feed a pipeline of more than 30 innovative drug programs, with 10+ in clinical stage and four products approved in China as of early 2026: 佳泰莱® (sac-TMT/SKB264/MK-2870, a TROP2 ADC approved for TNBC, EGFR-mutated NSCLC, and HR+/HER2- breast cancer), 科泰莱® (tagitanlimab/KL-A167, a PD-L1 monoclonal antibody for nasopharyngeal carcinoma), 达泰莱® (cetuximab N01/A140, an EGFR monoclonal antibody biosimilar for metastatic colorectal cancer), and 舒泰莱® (trastuzumab botidotin/A166, a HER2 ADC for HER2-positive breast cancer).

The company's business model combines (a) in-house commercialization in China through a direct sales force covering 30 provinces, supported by a strategic distribution agreement with Shanghai Pharmaceuticals Holdings signed December 2024, with three products (sac-TMT, tagitanlimab, cetuximab N01) included in the 2025 National Reimbursement Drug List effective January 1, 2026; and (b) global out-licensing of pipeline assets to multinational partners, most notably a multi-asset collaboration with MSD (Merck Sharp & Dohme) covering sac-TMT and up to seven additional ADC assets with up to $9.3 billion in potential milestones plus royalties, plus separate deals with Crescent Biopharma (up to $1.3 billion cross-licensing for SKB105 ITGB6 ADC and CR-001 PD-1xVEGF bispecific, December 2025), Windward Bio (TSLP antibody WIN378/SKB378, January 2025), Ellipses Pharma (A400/EP0031 RET inhibitor, March 2021), and $700M in funding from Blackstone Life Sciences (November 2025). The company employs 2,000+ team members including 100+ leading talents and approximately 1,800 R&D professionals.

FY2025 revenue reached RMB 2,057.92 million (approximately USD 285 million) with year-on-year growth of approximately 6.5%, gross profit of RMB 1,478.78 million, and a net loss of RMB 381.97 million (adjusted loss RMB 211.28 million) reflecting continued R&D investment. Manufacturing is anchored at a cGMP facility in Wenjiang District, Chengdu — one of few in China with end-to-end antibody and ADC production capacity, and notably the site of China's first ADC approved under the cross-province segmented production pilot model.

Name

Kelun Biotech

Legal name

四川科伦博泰生物医药股份有限公司 (Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.)

Website

https://kelun-biotech.com

Company type

Public

Founded year

2016

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) is a Chengdu-headquartered biopharmaceutical company developing and commercializing innovative antibody-drug conjugates, monoclonal antibodies, and small molecules for oncology and autoimmune disease, with four products approved in China and global licensing partnerships anchored by a multi-billion-dollar MSD collaboration.

Ownership category

akta.pro rank

Product category

Oncology Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834), Services-Commercial Physical & Biological Research (8731)

akta.pro industry

PRIMARYHLAAAAAF

Bispecific & Multispecific Antibodies

Healthcare & Life Sciences/Biotechnology & Biologics/Therapeutic Biologics (mAbs, recombinant proteins, cytokines)

SECONDARYHLAAAIAB

Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering)

Healthcare & Life Sciences/Biotechnology & Biologics/Biologic Drug Discovery Platforms (screening, antibody engineering, synthetic biology)

SECONDARYHLAAAAAH

Therapeutic Peptides & Protein/Peptide Biologics

Healthcare & Life Sciences/Biotechnology & Biologics/Therapeutic Biologics (mAbs, recombinant proteins, cytokines)

Keywords

• Antibody drug conjugates
• Oncology biopharmaceuticals
• ADC development platform
• Innovative cancer therapeutics
• Monoclonal antibody drugs

Headquarters

HQ city

Chengdu

HQ country

China

HQ region

Asia

Offices6 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Commercial drug product sales (China): Sales of four approved products (sac-TMT/佳泰莱®, tagitanlimab/科泰莱®, cetuximab N01/达泰莱®, trastuzumab botidotin/舒泰莱®) in China across oncology indications, with three products (佳泰莱®, 科泰莱®, 达泰莱®) included in the 2025 National Reimbursement Drug List effective January 1, 2026. Three products cover 8 approved indications in China.
2. Out-licensing / milestone payments (Global ex-Greater China): MSD (Merck) holds exclusive ex-Greater China rights to sac-TMT and other ADC assets under licensing and collaboration agreements. Original 2022 deal: $1.4B commitment; expanded to up to $9.3B in potential milestones across 7 ADC candidates plus royalties on net sales. Plus $700M Blackstone Life Sciences funding deal (Nov 2025) for sac-TMT.
3. Cross-licensing partnership with Crescent Biopharma: Strategic Dec 2025 deal: Kelun-Biotech received $80M upfront + up to $1.25B in milestones from Crescent for ex-Greater China rights to SKB105 (ITGB6 ADC); Kelun-Biotech paid $20M upfront + up to $30M milestones to Crescent for Greater China rights to CR-001 (PD-1 x VEGF bispecific). Combined deal value up to $1.3B.
4. Out-licensing of TSLP antibody (SKB378/WIN378) to Windward Bio: Kelun-Biotech and Harbour BioMed granted ex-Greater China and parts of Southeast/West Asia rights to WIN378 (SKB378/HBM9378) to Windward Bio (which raised $200M Series A); Kelun-Biotech received upfront in cash and equity (announced May 2025).
5. Out-licensing of A400/EP0031 RET inhibitor to Ellipses Pharma: March 2021 license to UK-based Ellipses Pharma for development outside Greater China (Kelun retains Greater China, Korea, Singapore, Malaysia). Ellipses is conducting a global Phase II trial in US, UK, Europe, UAE.

Go-to-market motion5 records

Distribution channels7 records

Marketing channels8 records

Core offering

Kelun Biotech is an integrated biopharmaceutical company that discovers, develops, manufactures and commercializes innovative drugs, with a primary focus on antibody-drug conjugates (ADCs), monoclonal antibodies (mAbs), bispecific antibodies, and small molecules for oncology and other major diseases. The company operates the proprietary OptiDC™ ADC platform alongside large-molecule biologics, AI-driven small molecule (CADD/AIDD), and translational medicine platforms, and currently markets four approved products in China (sac-TMT/佳泰莱®, tagitanlimab/科泰莱®, cetuximab N01/达泰莱®, and trastuzumab botidotin/舒泰莱®).

Product overview

Kelun-Biotech operates a platform-plus-modules architecture built around four core technology platforms — OptiDC™ (ADC), the Large-Molecule Biologics Platform, the Small-Molecule Platform (AIDD), and the Translational Medicine Platform — that together feed a unified pipeline of more than 30 drug programs. The four commercial products (佳泰莱®/sac-TMT, 科泰莱®/Tagitanlimab, 达泰莱®/Cetuximab N01, and 舒泰莱®/Trastuzumab Botidotin) are the marketed outputs of these platforms, while the broader oncology and non-oncology pipeline (SKB315, SKB410, SKB500, SKB518, SKB535, SKB571, SKB445, SKB103, SKB105/CR-003, SKB107, SKB118/CR-001, SKB336, SKB378, SKB575, A400/EP0031, etc.) is the in-flight R&D pipeline derived from the same four engines. The OptiDC™ platform is the dominant source of commercial revenue today, the Large-Molecule platform underpins the PD-L1 and EGFR mAbs as well as bispecific candidates, the AIDD small-molecule platform supports both internal candidates and partnerships (e.g., KL590586/A400 with Ellipses Pharma), and the Translational Medicine platform provides the shared clinical-translation backbone across all programs.

Differentiator

Problem solved

Functional benefit

Brands

• 佳泰莱® (Jia Tai Lai): Trade name for sacituzumab tirumotecan (sac-TMT, SKB264/MK-2870), the company's core TROP2 ADC product approved in China for multiple oncology indications including TNBC, EGFR-mutant NSCLC, and HR+/HER2- breast cancer.
• 科泰莱® (Ke Tai Lai)
• 达泰莱® (Da Tai Lai)
• 舒泰莱® (Shu Tai Lai)

Products and services

• 佳泰莱® (sac-TMT / SKB264 / MK-2870)
• 科泰莱® (Tagitanlimab / KL-A167)
• 达泰莱® (Cetuximab N01 / A140)
• 舒泰莱® (Trastuzumab Botidotin / A166)

Quantifiable outcome

• sac-TMT + pembrolizumab reduced disease progression risk by 65% vs pembrolizumab alone in 1L PD-L1+ NSCLC (HR=0.35; median PFS not reached vs 5.7 months; 12-month PFS 62.4% vs 29.0%)
• +9 more outcomes

Named customers5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability7 records

Feature8 records

Partnerships

Nine partnerships are on record, tiered co-development partner for tslp/autoimmune bispecifics and tslp antibody programs, major — combined deal value up to $1.3b; includes $185m private placement in crescent, mid — single asset (tslp antibody) deal; windward raised $200m series a and $165m crossover in 2026, core distribution partner in china, co-development partner for clinical research and engineering center, flagship — largest licensing partner; up to $9.3b total deal value across 7 adc assets including sac-tmt; 17+ global phase iii trials being conducted; $700m blackstone life sciences funding deal associated (nov 2025), mid — ret inhibitor niche; fda fast track designation granted for a400/ep0031 in nsclc, industry peer mentioned in competitive landscape reports and parent company and controlling shareholder.

• Harbour BioMedco-development partner for tslp/autoimmune bispecifics and tslp antibody programsStrategic or Co-development Partner · 9 March 2026Co-development partnership for SKB575/HBM7575 (bispecific antibody targeting TSLP and undisclosed antigen for atopic dermatitis) with long half-life supporting >3 month dosing intervals. Kelun-Biotech leads global development and commercialization; Harbour BioMed participates in investment and development, sharing agreed benefits. IND approved by NMPA March 2026. Also partnered on HBM9378/SKB378/WIN378 TSLP antibody. Harbour BioMed has strategic focus on immunology and immuno-oncology and reported 2024 revenue of US$38.1M with ~US$2.7M overall profit.
• Crescent Biopharmamajor — combined deal value up to $1.3b; includes $185m private placement in crescentStrategic or Co-development Partner · 4 December 2025December 2025 strategic partnership: Kelun-Biotech received $80M upfront plus up to $1.25B in milestones from Crescent for ex-Greater China rights to SKB105 (ITGB6 ADC, now CR-003); Kelun-Biotech paid $20M upfront plus up to $30M milestones to Crescent for Greater China rights to CR-001 (PD-1 x VEGF bispecific). Plans to evaluate CR-001 in combination with SKB105. ASCEND Phase 1/2 trial for CR-001 initiated Q1 2026 (up to 290 patients across US, Europe, Asia Pacific). IND approvals received in both US (FDA) and China (NMPA) Dec 2025/Jan 2026.
• Windward Biomid — single asset (tslp antibody) deal; windward raised $200m series a and $165m crossover in 2026Strategic or Co-development Partner · 10 January 2025January 2025 exclusive licensing agreement: Kelun-Biotech (with Harbour BioMed) granted Windward Bio ex-Greater China and parts of Southeast/West Asia rights to WIN378 (SKB378/HBM9378), a long-acting anti-TSLP antibody. Windward launched in January 2025 with $200M Series A; raised additional $165M in 2026. Kelun-Biotech received upfront in cash and equity (May 2025). Windward advanced WIN378 to Phase 2 for asthma and initiated Phase 2 SIRIUS study for COPD.
• Shanghai Pharmaceuticals Holdings (上药控股)core distribution partner in chinaChannel Partner/ Reseller/ Distributor · 10 December 2024Strategic cooperation agreement signed December 10, 2024 to accelerate nationwide distribution of Kelun-Biotech's innovative drugs in China. Supports the launch of sac-TMT (佳泰莱®), tagitanlimab (科泰莱®), cetuximab N01 (达泰莱®), and trastuzumab botidotin (舒泰莱®) across hospital channels.
• Southwest Medical University Affiliated Hospital (西南医科大学附属医院)co-development partner for clinical research and engineering centerStrategic or Co-development Partner · 14 September 2023Co-built the National Engineering Research Center for Biological Targeted Drugs with the hospital, with the unveiling ceremony held in December 2022 in Luzhou, Sichuan. Supports joint clinical research and translational medicine. Also served as one of the founding units of the National Engineering Research Center for Biological Targeted Drugs (along with CAS Shanghai Institute of Materia Medica, China Pharmaceutical University, Zhejiang University First Affiliated Hospital, Huazhong University of Science and Technology Tongji Hospital, Central South University Xiangya Second Hospital, Jiangsu Province People's Hospital, Zhengzhou University First Affiliated Hospital, Sichuan Kelun Pharmaceutical, and National Precision Medical Industry Innovation Center).
• Merck & Co. (MSD)flagship — largest licensing partner; up to $9.3b total deal value across 7 adc assets including sac-tmt; 17+ global phase iii trials being conducted; $700m blackstone life sciences funding deal associated (nov 2025)Strategic or Co-development Partner · 13 May 2022Originally signed May 2022 licensing sac-TMT (SKB264/MK-2870) ex-Greater China rights. Expanded December 2022 to include 7 additional preclinical ADC assets (up to $1.75B upfront, $9.3B total potential milestones). MSD holds exclusive rights to develop, manufacture, and commercialize sac-TMT outside Greater China. FDA granted National Priority Voucher to sac-TMT in Dec 2025, accelerating review to 1-2 months. Merck discontinued its own early-stage TROP ADC (MK-6837) to focus on Kelun's sac-TMT.
• Ellipses Pharma Limitedmid — ret inhibitor niche; fda fast track designation granted for a400/ep0031 in nsclcStrategic or Co-development Partner · 1 March 2021March 2021 licensing agreement: Kelun-Biotech granted Ellipses Pharma exclusive rights to A400/EP0031 (next-generation selective RET inhibitor / KL590586) outside Greater China, Korea, Singapore, and Malaysia. Ellipses received FDA IND clearance in 2022 and dosed first US patient Nov 2022. Pivotal Phase II data presented at ASCO 2026 (ORR 81.3% in treatment-naive and 87.1% in pre-treated RET fusion-positive NSCLC; 92.5% DCR in CNS metastases). Kelun-Biotech filed NDA in China; FDA-cleared Phase II recruiting in US, UK, Europe, UAE.
• Akeso/Summit Therapeutics (peer/competitor collaboration context)industry peer mentioned in competitive landscape reportsOthersSummit Therapeutics licensed ivonescimab from China's Akeso for $500M upfront as a comparable China-out-licensing deal mentioned in same context as Kelun's $9.3B MSD deal. Both are cited as examples of increasing flow of biotech assets from China to global pharma. Not a formal partnership.
• Kelun Pharmaceutical (科伦药业) - Parent Companyparent company and controlling shareholderStrategic or Co-development PartnerSichuan Kelun-Biotech Biopharmaceutical Co., Ltd. is a controlling subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd. (002422.SZ). Kelun Pharmaceutical was founded by Chairman Liu Gexin and provides decades of experience, industry relationships, and broad networks supporting Kelun-Biotech's commercialization infrastructure and market channels. Kelun Pharmaceutical has invested over RMB 10 billion in R&D since 2013 and provides clinical sample production support. Kelun-Biotech was founded in 2016 as a controlled subsidiary focused on innovative biological drugs and small molecules.

Scale indicators12 records

Recent moves14 records

Expansion highlights8 records

Direct peers

• RemeGen Co., Ltd. Hong Kong-listed Chinese biopharmaceutical company (HKEX: 9995) focused on antibody therapeutics including ADCs (disitamab vedotin) and bispecifics. Directly comparable as a China-based ADC developer with commercial-stage oncology products and global out-licensing deals (Seagen/Pfizer partnership).
• Hansoh Pharmaceutical Group: Hong Kong-listed Chinese pharmaceutical company (HKEX: 3692) with leading oncology and CNS franchises. Kelun's small-molecule CSO Dr. Yu Wensheng is a former Hansoh executive. Both companies compete in innovative oncology drug development with overlapping R&D infrastructure and talent pools.
• Akeso, Inc. Hong Kong-listed Chinese biopharmaceutical company (HKEX: 09926) and pioneer of bispecific antibodies, including ivonescimab (PD-1xVEGF). Kelun's CMO Dr. Jin Xiaoping is a former Akeso executive. Highly comparable in oncology biologics development, China commercial footprint, and out-licensing model (Summit/Akeso ivonescimab deal).
• Innovent Biologics: Hong Kong-listed Chinese biopharmaceutical company (HKEX: 1801) developing innovative oncology biologics including PD-1 (sintilimab), bispecifics, and ADCs. Directly comparable as a top-tier Chinese oncology biotech with commercial products, global partnerships, and overlapping indications in lung and GI cancers.

Broad incumbents

• BeiGene (now BeOne Medicines): Global oncology company (NASDAQ: ONC, formerly BGNE) with Chinese R&D roots and the PD-1 tislelizumab. Comparable as a major Chinese-origin oncology biotech with approved products, global commercial reach, and competing PD-1/PD-L1 and oncology assets in similar indications.
• Daiichi Sankyo: Japanese global pharmaceutical company and ADC leader, co-developer of Enhertu (HER2 ADC) and Dato-DXd (TROP2 ADC) with AstraZeneca. Direct competitor in the TROP2 and HER2 ADC spaces where sac-TMT and trastuzumab botidotin compete. Dr. Jin Xiaoping is a former Daiichi Sankyo executive.
• Jiangsu Hengrui Medicine: Largest Chinese innovative pharmaceutical company (SSE: 600276) with a broad oncology pipeline including ADC assets (e.g., SHR-A1811). Comparable as a major incumbent Chinese pharma with innovative biologics, global licensing deals, and direct competition in oncology indications overlapping with Kelun's pipeline.

Regional players

• CSPC Pharmaceutical Group: Hong Kong-listed Chinese pharmaceutical company (HKEX: 1093) with a substantial oncology and biologics pipeline including ADC candidates. Comparable as a major Chinese pharma peer with overlapping therapeutic areas and competing for the same China NRDL access and global out-licensing opportunities.
• Shanghai Junshi Biosciences: Hong Kong-listed Chinese biopharmaceutical company (HKEX: 1877) and developer of toripalimab (PD-1). Kelun's Deputy GM Chen Wei is a former Junshi executive. Comparable in the China immuno-oncology space with similar BD and market access challenges.

Emerging players

• Crescent Biopharma: US-based clinical-stage biopharmaceutical company (NASDAQ: CRBN) focused on oncology. Direct peer through the December 2025 cross-territorial licensing deal (Kelun licensed ex-China rights to SKB105/CR-003; Crescent licensed Greater China rights to CR-001/PD-1xVEGF bispecific).

Market position

Strengths5 records

Weaknesses5 records

Competitive moat7 records

Key risks7 records

Key highlights7 records

Customer concentration

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries7 records

Funding overview

Funding rounds5 records

Investors9 records

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M&A

Investments

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Frequently asked questions about Kelun Biotech