Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

https://en.kelun-biotech.com/

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., operating as Kelun-Biotech, is a biopharmaceutical company dedicated to the research and development, manufacturing, commercialization, and global collaboration of innovative biological and small molecule drugs. Established in 2016, the company's mission is to address significant unmet medical needs in China and worldwide, with a strategic focus on major disease areas such as oncology, autoimmune disorders, and metabolic diseases. Its headquarters are located in Chengdu, Sichuan, China.

Kelun-Biotech is a pioneer in the development of Antibody-Drug Conjugates (ADCs) and novel Drug Conjugates (DCs), having established its proprietary OptiDC™ platform. The company's product portfolio includes two marketed ADC drugs: sacituzumab tirumotecan (sac-TMT), approved for indications such as triple-negative breast cancer and EGFR-mutated non-small cell lung cancer, and trastuzumab botidotin, approved for HER2-positive breast cancer. Beyond ADCs, its pipeline features over 30 innovative drug projects, with several in clinical stages, including Tagitanlimab (a PD-L1 mAb), Cetuximab N01 (an EGFR mAb), A400 (a RET inhibitor), and A296 (a STING agonist).

In recent developments, Kelun-Biotech's ITGB6-targeted ADC, SKB105, received Investigational New Drug (IND) approval for advanced solid tumors in January 2026. Additionally, sac-TMT in combination with pembrolizumab was granted Breakthrough Therapy Designation for the first-line treatment of PD-L1 positive non-small cell lung cancer. Led by Executive Director, President, and CEO Dr. Ge Junyou, Kelun-Biotech has positioned itself as a leader in China's innovative drug sector, actively expanding its global presence through strategic partnerships with companies like MSD, Ellipses, Windward Bio, and Crescent Biopharma. The company was successfully listed on the Hong Kong Stock Exchange in July 2023.

Latest updates

Kelun-Biotech Presents Promising Clinical Data at Upcoming ASCO Meeting

Event summary

  • Kelun-Biotech will present data from three clinical studies at the 2026 ASCO Annual Meeting, including its TROP2 ADC sacituzumab tirumotecan (sac-TMT), RET inhibitor lunbotinib (A400/EP0031), and novel ADC SKB500.
  • The ASCO presentations include an oral presentation of a Phase III trial evaluating sac-TMT plus pembrolizumab versus pembrolizumab for NSCLC.
  • Lunbotinib’s efficacy and safety data from a pivotal Phase II study in RET fusion-positive NSCLC will also be presented orally.
  • SKB500 will be featured in a rapid oral presentation as part of an open-label, first-in-human study.

The big picture

Kelun-Biotech's ASCO presentations highlight its growing prominence in the oncology space, particularly with its focus on ADCs. The company’s strategic partnerships with MSD and Ellipses Pharma demonstrate a deliberate effort to expand its global reach. The data presented will be critical for shaping investor sentiment and influencing future development decisions for these key assets.

What we're watching

Clinical Validation
The upcoming ASCO presentations will be crucial in validating the clinical efficacy and safety of sac-TMT, particularly given its global commercialization partnership with MSD and existing approvals in China.
Regulatory Pathway
The FDA’s progress on lunbotinib, currently in Phase II trials, will be a key indicator of its potential for broader international market access beyond Greater China.
Pipeline Depth
The early-stage data on SKB500 will reveal the potential of Kelun-Biotech’s OptiDC platform and its ability to generate a robust pipeline of novel ADCs.

Sac-TMT Combo Shows Promise in Gynecologic Oncology, Bolstering Kelun-Biotech Pipeline

Event summary

  • Kelun-Biotech presented Phase II data at the 2026 SGO Annual Meeting for sacituzumab tirumotecan (sac-TMT) in combination with pembrolizumab for ovarian and cervical cancers.
  • In ovarian cancer, the combination therapy demonstrated a median progression-free survival (PFS) of 20.9 months and a 12-month overall survival (OS) rate of 92%.
  • For cervical cancer, the combination achieved a 51% objective response rate (ORR) and a median OS of 18.9 months.
  • Sac-TMT is a TROP2-directed antibody-drug conjugate (ADC) licensed to MSD for global commercialization outside of Greater China.

The big picture

Kelun-Biotech's sac-TMT program represents a significant asset in the crowded ADC space, particularly given its unique bifunctional linker design and potential bystander effect. The positive Phase II data, presented in conjunction with MSD, strengthens the commercial viability of the partnership and positions sac-TMT as a potential treatment option for patients with recurrent ovarian and cervical cancers, both areas with significant unmet medical need. The licensing deal with MSD provides Kelun-Biotech with a substantial revenue stream and access to global commercialization expertise.

What we're watching

Regulatory Path
The positive data presented will likely accelerate discussions with regulatory bodies in both China and outside territories, but the specifics of approval pathways remain to be seen.
Commercialization
MSD’s execution of global commercialization efforts will be critical to the success of sac-TMT, particularly given the existing competitive landscape in oncology.
Clinical Expansion
The ongoing Phase III trials sponsored by MSD will determine if these early signals of efficacy translate to a registrational outcome and broader clinical adoption.

Kelun-Biotech Sheds 'B' Marker, Signaling Accelerated Growth

Event summary

  • Kelun-Biotech (6990.HK) has been approved by the Hong Kong Exchange (HKEX) to remove the 'B' marker from its stock code, effective April 14, 2026.
  • The company has secured approvals for 4 products across 8 indications within three years of its listing, with 3 products covering 5 indications included in China's National Reimbursement Drug List (NRDL).
  • Kelun-Biotech is collaborating with MSD on 17 global Phase III clinical trials for sacituzumab tirumotecan (sac-TMT), with data readouts anticipated soon.
  • The company is advancing a pipeline transitioning from 'best-in-class' (BIC) assets like sac-TMT to 'first-in-class' (FIC) candidates.

The big picture

The removal of the 'B' marker signifies a maturation of Kelun-Biotech's governance and operational performance, allowing for greater investor confidence and potentially opening doors to larger institutional investment. This move aligns with a broader trend of Chinese biopharmaceutical companies seeking to enhance their global credibility and access international capital markets. The company's focus on ADC and novel conjugation technologies positions it within a rapidly growing segment of the oncology therapeutics market, but success hinges on clinical trial outcomes and regulatory approvals.

What we're watching

Clinical Trial Outcomes
The success of the 17 Phase III clinical trials for sacituzumab tirumotecan will be a key determinant of Kelun-Biotech's near-term revenue growth and global market penetration.
FIC Pipeline
The ability of Kelun-Biotech to translate its FIC pipeline candidates from preclinical to commercial stages will be crucial for long-term differentiation and sustainable competitive advantage.
NRDL Access
Continued inclusion of Kelun-Biotech's products on China's National Reimbursement Drug List (NRDL) will be essential for maintaining market access and driving sales volume within the Chinese market.

Kelun-Biotech Advances TAA-PD-L1 ADC Candidate into China Trials

Event summary

  • Kelun-Biotech received Investigational New Drug (IND) approval in China for SKB103, a TAA-PD-L1 bispecific antibody-drug conjugate (bsADC).
  • SKB103 is the company’s first TAA-PD-L1 bsADC candidate and the second bsADC program to enter clinical trials, following SKB571.
  • The approval was granted by the CDE of the NMPA for the treatment of advanced solid tumors.
  • Kelun-Biotech utilizes its proprietary OptiDC™ platform for ADC development.

The big picture

Kelun-Biotech's IND approval for SKB103 underscores the intensifying competition in the oncology ADC space, particularly in China, where regulatory pathways are becoming increasingly streamlined. The company’s focus on dual-mechanism ADCs (TAA-PD-L1) represents a strategic attempt to overcome resistance and improve efficacy compared to single-target therapies. Kelun-Biotech's existing ADC portfolio and OptiDC™ platform provide a foundation for continued innovation, but execution risk remains high given the complexity of ADC development.

What we're watching

Clinical Efficacy
The initial clinical trial data for SKB103 will be crucial in validating the preclinical findings and establishing its potential as a best-in-class therapy, particularly given the crowded ADC landscape.
Regulatory Pathway
The speed and efficiency of the clinical trial approval process in China will influence the overall timeline for SKB103’s commercialization and Kelun-Biotech’s ability to compete globally.
Platform Scalability
The success of SKB103 will hinge on Kelun-Biotech’s ability to leverage its OptiDC™ platform to rapidly advance other ADC and novel DC candidates through the pipeline.

Kelun-Biotech Posts Strong Revenue Growth, Navigates Path to Profitability

Event summary

  • Kelun-Biotech reported RMB 2057.92 million in revenue for 2025, with a gross profit of RMB 1478.78 million.
  • The company incurred a loss of RMB 381.97 million, but adjusted annual loss was RMB 211.28 million.
  • Kelun-Biotech maintains a strong cash position with RMB 4559.36 million in cash and financial assets.
  • Four products with eight indications are approved for marketing in China, with three included in the 2025 National Reimbursement Drug List (NRDL).

The big picture

Kelun-Biotech's results highlight the increasing sophistication of China's biopharmaceutical sector, with a focus on advanced therapies like ADCs. The company's aggressive R&D investment and strategic partnerships signal a commitment to global competitiveness, but also create pressure to demonstrate a clear path to profitability. The inclusion of multiple products on the NRDL provides a significant boost to commercialization, but also underscores the importance of navigating China's evolving reimbursement landscape.

What we're watching

Clinical Trial Success
The success of ongoing Phase 3 trials for sac-TMT, particularly in HR+/HER2- BC and EGFR-mutant NSCLC, will be crucial for long-term revenue growth and market share.
Profitability Trajectory
Whether Kelun-Biotech can transition to sustained profitability, given its significant R&D expenses, will depend on successful product launches and pricing strategies.
International Expansion
The pace at which Kelun-Biotech can expand its commercial presence outside of China, leveraging partnerships like those with MSD and Crescent Biopharma, will determine its global competitiveness.

Kelun-Biotech's Sac-TMT OS Data Confirms Survival Benefit in EGFR-Mutant NSCLC

Event summary

  • Kelun-Biotech will present final overall survival (OS) analysis from the OptiTROP-Lung03 study at the 2026 European Lung Cancer Congress (ELCC) in Copenhagen.
  • The OptiTROP-Lung03 study demonstrated a median OS of 20.0 months for sac-TMT vs. 11.2 months for docetaxel (HR 0.45, 95% CI: 0.28–0.73) after adjusting for crossover treatment.
  • Sac-TMT has already received NMPA approval for this indication and is included in China's National Reimbursement Drug List (NRDL).
  • The OptiTROP-Lung04 study showed a median OS of 20 months for sac-TMT in EGFR-mutant NSCLC patients post-EGFR-TKI and platinum-based chemotherapy.

The big picture

Kelun-Biotech's sac-TMT represents a significant advancement in the treatment of EGFR-mutant NSCLC, a market with substantial unmet need and growing competition. The consistent positive data across multiple trials, coupled with NMPA approval and reimbursement, positions sac-TMT as a leading therapeutic option in China. However, the company's reliance on Merck for global commercialization outside of China introduces a dependency that could impact long-term revenue potential.

What we're watching

Crossover Impact
The significant crossover of patients from the docetaxel group to sac-TMT raises questions about the true impact of the initial treatment arms and necessitates careful interpretation of the adjusted OS data.
Global Expansion
The licensing agreement with Merck & Co. suggests a potential for broader global commercialization; however, the success of sac-TMT outside of China remains to be seen.
Clinical Adoption
The pace at which clinicians adopt sac-TMT, particularly given its inclusion in the NRDL, will be a key indicator of its long-term market penetration and revenue generation.

Kelun-Biotech, Harbour BioMed Secure NMPA Approval for Atopic Dermatitis Candidate

Event summary

  • Kelun-Biotech and Harbour BioMed received NMPA approval for an IND application for SKB575/HBM7575, a bispecific antibody targeting TSLP and an undisclosed antigen.
  • The candidate is designed for the treatment of atopic dermatitis, a condition affecting approximately 20% of children and 10% of adults globally.
  • SKB575/HBM7575 is expected to have a long-acting profile, potentially enabling dosing intervals of over three months.
  • Kelun-Biotech leads the design, global development, and commercialization of the asset, with Harbour BioMed participating in investment and development.

The big picture

The approval represents a strategic move by Kelun-Biotech to expand its presence in the autoimmune disease space, leveraging Harbour BioMed’s antibody technology platform. The long-acting profile of SKB575/HBM7575 addresses a key unmet need in atopic dermatitis treatment – sustained disease control with reduced dosing frequency – potentially offering a competitive advantage. The undisclosed target adds an element of strategic opacity, suggesting a novel mechanism designed to overcome resistance seen with TSLP-targeting therapies alone.

What we're watching

Clinical Efficacy
The success of SKB575/HBM7575 will hinge on demonstrating superior efficacy and safety compared to existing treatments in clinical trials, particularly given the prevalence of JAK inhibitors and topical corticosteroids.
Undisclosed Target
The undisclosed target's identity and mechanism of action will be critical to understanding the drug's overall effectiveness and potential for synergistic effects with TSLP blockade.
Commercialization
Kelun-Biotech’s ability to effectively commercialize the drug in China and potentially globally will depend on navigating the NMPA approval process and establishing a robust distribution network.

Kelun-Biotech Secures Fourth China Approval for Sacituzumab Tirumotecan

Event summary

  • Kelun-Biotech’s sacituzumab tirumotecan (sac-TMT) received NMPA approval for HR+/HER2- breast cancer patients who have received prior endocrine therapy and at least one line of chemotherapy.
  • The approval is based on Phase III OptiTROP-Breast02 study data, presented as a Late-Breaking Abstract at the 2025 ESMO Congress.
  • The study demonstrated a statistically significant increase in progression-free survival (PFS) with sac-TMT (8.3 vs. 4.1 months, HR=0.35).
  • This marks the fourth indication for sac-TMT approved for marketing in China.

The big picture

The approval underscores the growing importance of China’s biopharmaceutical market and the increasing acceptance of ADCs in cancer treatment. Kelun-Biotech’s strategy of licensing out ex-China rights to MSD suggests a focus on domestic market penetration while leveraging MSD’s global commercial infrastructure. The consistent PFS benefits across subgroups in the OptiTROP-Breast02 study strengthens sac-TMT’s position as a valuable treatment option for a significant patient population with limited therapeutic alternatives.

What we're watching

Clinical Trials
The ongoing Phase III trials combining sac-TMT with pembrolizumab will be crucial in expanding its clinical utility and potentially broadening its market reach, particularly in earlier lines of therapy.
Commercialization
The impact of sac-TMT’s inclusion on China’s National Reimbursement Drug List (NRDL) will determine the pace of adoption and revenue generation within the Chinese market.
Global Expansion
How MSD leverages its exclusive rights outside of Greater China will dictate sac-TMT’s overall commercial success and Kelun-Biotech’s revenue diversification.

Kelun-Biotech Highlights ADC Pipeline, Global Ambitions at JPM Healthcare Conference

Event summary

  • Kelun-Biotech showcased its ADC and novel drug conjugate (DC) pipeline at the JPM Healthcare Conference on January 15, 2026.
  • The company has two ADC products on the market (sacituzumab tirumotecan and trastuzumab botidotin) and nine ADC/DC drugs in clinical stages.
  • Results from the OptiTROP-Lung04 study of sac-TMT were published in The New England Journal of Medicine.
  • Kelun-Biotech has five commercialized products in China, three of which are on the National Reimbursement Drug List (NRDL).

The big picture

Kelun-Biotech's emergence as a leader in China's innovative drug field, particularly in ADCs, reflects the broader trend of increased investment and innovation within the Chinese biopharmaceutical sector. The company's focus on high-incidence cancers aligns with China's growing healthcare needs and government support for domestic drug development. The partnership with MSD signals an ambition to compete on a global scale, but also introduces dependencies and potential IP-related risks.

What we're watching

Globalization
The success of Kelun-Biotech's collaborations with MSD and other partners will be critical for its international expansion and ability to recoup R&D investments.
Clinical Execution
The pace of clinical trial enrollment and data readouts for the nine pivotal studies in China will dictate the timeline for potential market expansion and revenue growth.
Platform Risk
While the OptiDC™ platform is a key differentiator, its ability to consistently generate novel, effective ADC/DC candidates will determine Kelun-Biotech’s long-term competitive advantage.

Kelun-Biotech to Present at J.P. Morgan Conference Amid Global Pharma Shift

Event summary

  • Kelun-Biotech (6990.HK) is attending the 44th J.P. Morgan Healthcare Conference in San Francisco, January 12-15, 2026.
  • CEO Michael Ge will present on January 15, 2026, at 9:30 AM PST.
  • Kelun-Biotech has 30+ ongoing drug projects, 4 approved, 1 in NDA stage, and over 10 in clinical trials.
  • The company has proprietary ADC and novel DC platforms, OptiDC™, with 2 approved ADC products.

The big picture

Kelun-Biotech's participation in J.P. Morgan Healthcare Conference highlights the increasing globalization of Chinese biopharmaceutical companies and their ambition to compete on the world stage. The company's focus on ADC and novel DC platforms positions it within a rapidly expanding market segment, but its success hinges on securing international collaborations and navigating complex regulatory hurdles.

What we're watching

Partnership Strategy
Kelun-Biotech’s stated pursuit of international partnerships will be scrutinized for the type and scale of deals secured, indicating the company’s appetite for risk and potential impact on its financial performance.
OptiDC™ Progress
The advancement of Kelun-Biotech’s OptiDC™ platform beyond the two approved ADC products will be a key indicator of its long-term competitive advantage in the crowded oncology space.
China Regulatory Landscape
The speed with which Kelun-Biotech can navigate China’s evolving regulatory environment will influence the timeline for its NDA submission and subsequent commercialization of its pipeline drugs.

Kelun-Biotech Secures China IND Approval for ITGB6-Targeted ADC, Expands Global Partnership

Event summary

  • Kelun-Biotech received Investigational New Drug (IND) approval from the NMPA in China for SKB105, an ITGB6-targeted ADC, for the treatment of advanced solid tumors.
  • In December 2025, Kelun-Biotech entered a strategic collaboration with Crescent Biopharma, granting Crescent rights to SKB105 outside of Greater China.
  • Crescent Biopharma holds rights to commercialize SKB118 (PD-1 x VEGF bispecific antibody) in Greater China.
  • The FDA has cleared the IND application for SKB118, and a global Phase I/II trial is slated to begin shortly.

The big picture

This IND approval and partnership represent a significant step for Kelun-Biotech, demonstrating its commitment to developing innovative oncology therapies and expanding its global reach. The deal with Crescent Biopharma allows Kelun-Biotech to focus on its core R&D and manufacturing capabilities while leveraging Crescent’s commercial expertise in key markets. The simultaneous development of both SKB105 and SKB118 highlights a strategic focus on combination therapies within the solid tumor space, a rapidly evolving area of oncology drug development.

What we're watching

Clinical Efficacy
The initial Phase I/II trial data for SKB105 will be crucial in determining its potential efficacy and safety profile in human patients, which will inform future development and regulatory pathways.
Commercialization
The success of the partnership with Crescent Biopharma will hinge on their ability to navigate regulatory hurdles and establish a commercial footprint for SKB105 in key global markets.
Pipeline Synergy
Kelun-Biotech’s plans to submit an IND application for SKB118 to the NMPA will reveal the company’s commitment to leveraging the partnership and expanding its presence in the Chinese market.

Kelun-Biotech Secures China Breakthrough Designation for ADC Combo

Event summary

  • Kelun-Biotech received Breakthrough Therapy Designation (BTD) in China for sacituzumab tirumotecan (sac-TMT) combined with pembrolizumab for first-line treatment of PD-L1-positive, EGFR-negative, ALK-negative NSCLC.
  • The BTD designation expedites the review process for potential marketing authorization in China.
  • Clinical trial OptiTROP-Lung05 demonstrated statistically significant improvement in progression-free survival (PFS) and a positive trend in overall survival (OS).
  • This marks the fifth BTD granted to sac-TMT, expanding its potential applications across multiple cancer types.
  • Sac-TMT is licensed to MSD for all territories outside of Greater China.

The big picture

The BTD designation underscores the growing importance of China as a key market for innovative cancer therapies. Sac-TMT's approval, and the subsequent inclusion on the National Reimbursement Drug List (NRDL), could significantly impact Kelun-Biotech's revenue and market share within the rapidly expanding Chinese oncology market. The combination therapy represents a shift towards more targeted and effective treatments for NSCLC, a disease with a significant unmet need.

What we're watching

Regulatory Speed
The expedited review pathway afforded by the BTD designation will be a key indicator of the NMPA's commitment to accelerating innovative cancer therapies, and could set a precedent for future ADC approvals.
Commercial Execution
Kelun-Biotech's ability to successfully manufacture and distribute sac-TMT in China, alongside MSD's commercial infrastructure outside of China, will be crucial for realizing the full potential of this combination therapy.
Clinical Data
Further clinical data, particularly regarding overall survival (OS) and long-term safety, will be critical to solidify sac-TMT's position in the competitive NSCLC treatment landscape.
CID: 656