{"id":52908,"date":"2026-01-05T22:33:56","date_gmt":"2026-01-05T14:33:56","guid":{"rendered":"https:\/\/flcube.com\/?p=52908"},"modified":"2026-01-05T22:33:58","modified_gmt":"2026-01-05T14:33:58","slug":"kelun-biotechs-itgb6-adc-skb105-wins-nmpa-ind-approval","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=52908","title":{"rendered":"Kelun-Biotech’s ITGB6 ADC SKB105 Wins NMPA IND Approval"},"content":{"rendered":"\n

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.<\/strong> (HKG: 6990<\/a>) announced that its Investigational New Drug (IND) application for SKB105<\/strong>, an integrin beta\u20116 (ITGB6)\u2011targeted antibody\u2011drug conjugate (ADC)<\/strong>, has been approved by the Center for Drug Evaluation (CDE)<\/strong> of China\u2019s National Medical Products Administration (NMPA)<\/strong> for the treatment of advanced solid tumors<\/strong>.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Product<\/strong><\/td>SKB105 (ITGB6\u2011targeted ADC)<\/td><\/tr>
Company<\/strong><\/td>Sichuan Kelun\u2011Biotech (6990.HK)<\/td><\/tr>
Target<\/strong><\/td>Integrin beta\u20116 (ITGB6)<\/td><\/tr>
Payload<\/strong><\/td>Topoisomerase 1 inhibitor<\/td><\/tr>
Regulatory Status<\/strong><\/td>IND approved by CDE\/NMPA<\/td><\/tr>
Indication<\/strong><\/td>Advanced solid tumors<\/td><\/tr>
Technology<\/strong><\/td>Kthiol irreversible conjugation<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Technology & Differentiation<\/h2>\n\n\n\n

Mechanism of Action<\/strong>: SKB105 targets ITGB6<\/strong>, which is overexpressed in many solid tumors<\/strong> but shows minimal to no expression in most normal tissues<\/strong>, potentially reducing systemic toxicity and off\u2011target effects.<\/p>\n\n\n\n

Kthiol Conjugation<\/strong>: Proprietary irreversible conjugation technology<\/strong> enhances linker\u2011payload stability<\/strong> and tumor\u2011specific delivery<\/strong>, while reducing adverse effects compared to traditional ADCs.<\/p>\n\n\n\n

Preclinical Profile<\/strong>: Demonstrated favorable efficacy, safety, and pharmacokinetic (PK) profile<\/strong> in preclinical models.<\/p>\n\n\n\n

Strategic Crescent Biopharma Collaboration<\/h2>\n\n\n\n

In December\u202f2025<\/strong>, Kelun\u2011Biotech entered into a strategic collaboration with Crescent Biopharma, Inc.<\/strong>:<\/p>\n\n\n\n

Product<\/th>Region<\/th>Rights Holder<\/th><\/tr><\/thead>
SKB105<\/strong> (CR\u2011003)<\/td>US, Europe, Ex\u2011Greater China<\/td>Crescent Biopharma<\/td><\/tr>
SKB118\/CR\u2011001<\/strong> (PD\u20111\u00d7VEGF bispecific)<\/td>Greater China<\/td>Kelun\u2011Biotech<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Transaction Rationale<\/strong>: Cross\u2011license structure<\/strong> allows Kelun to monetize SKB105 globally while gaining access to SKB118\/CR\u2011001<\/strong>, a PD\u20111\u00d7VEGF bispecific antibody, for the Greater China market.<\/p>\n\n\n\n

SKB118 IND<\/strong>: Kelun\u2011Biotech plans to submit an IND application for SKB118\/CR\u2011001 in China in the near future<\/strong>.<\/p>\n\n\n\n

Market Opportunity<\/h2>\n\n\n\n

Global ADC Market<\/strong>: $15\u202fbillion<\/strong> (2025), growing at 25% CAGR<\/strong>. ITGB6 is a novel target<\/strong> with limited competition<\/strong>, offering first\u2011mover advantage in solid tumors including lung, breast, pancreatic, and gastric cancers<\/strong>.<\/p>\n\n\n\n

Revenue Projections<\/strong>:<\/p>\n\n\n\n