Kelun-Biotech Announces 2026 Interim Results

CHENGDU, China, Aug. 17, 2026 /PRNewswire/ — Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech” or the “Firm“, Inventory Code: 6990.HK) publicizes its unaudited consolidated outcomes for the interval ended 30 June 2026 (the “Reporting Interval“).

Key data is as follows:

• Income amounted to roughly RMB 978 million, with gross sales of pharmaceutical merchandise reaching RMB 657 million, up by 112% in comparison with the identical interval final 12 months, pushed by two elements: knowledgeable recognition of top of the range medical information and shift in therapy paradigms, and complete enhancement of drug accessibility.
• The Firm has established a complete operational system in China encompassing R&D, manufacturing, high quality administration, and commercialization, with built-in drug improvement capabilities. The Firm can also be pursuing world enlargement via worldwide collaborations, leveraging exterior partnerships to build up world medical improvement and commercialization expertise, whereas exploring diversified pathways to progressively obtain impartial abroad market entry.
• Specializing in ADC and novel DC, the Firm not solely has two ADC merchandise which were accredited for advertising and marketing, however has additionally constructed a product pipeline that’s differentiated and complimentary to accredited ADCs in indications, efficacy efficiency and security profile. By the free mixture of conjugation drug parts, in addition to the pairing with a various vary of concentrating on conjugates together with antibodies, small molecules, and peptides that leverage TAA/IO/ anti-angiogenetic-based mechanisms, the Firm has proactively positioned modern DC property, together with single-payload DCs reminiscent of radioisotope-based/ immuno-agonist-based/degrader-based, and dual-payload DCs reminiscent of cytotoxin + cytotoxin or immuno-agonist or degrader mixtures, amongst others.
• Doubling down on ADC + IO therapies, together with the mixture of ADCs with PD-(L)1 or PD-1/VEGF brokers, in addition to the event of drug candidates with synergetic MoAs inside one ADC compound.
• Past oncology, the Firm has additionally expanded into essential therapeutic areas reminiscent of autoimmune and metabolic ailments, and is at present conducting a number of medical research for bronchial asthma, persistent obstructive pulmonary illness (COPD), and atopic dermatitis.

Medical improvement progresses effectively, with a tiered enlargement of the pipeline matrix

Specializing in high-incidence tumors reminiscent of lung most cancers and breast most cancers, the Firm has constructed a well-layered medical pipeline with vital synergistic potential, masking drug modalities together with ADCs, immunotherapies, and small-molecule focused therapies, whereas additional increasing into main therapeutic areas reminiscent of autoimmune and metabolic ailments.

Permitted ADC Merchandise

Sac-TMT (TROP2 ADC, sacituzumab tirumotecan) (often known as SKB264/MK-2870) (佳泰莱^®)
The product has at present acquired advertising and marketing approval for 4 indications, specifically 2L+ TNBC, 2L/3L EGFR-mutant NSCLC, and 2L+ HR+/HER2- BC. As well as, two new indication drug functions have been accepted for overview, masking the mixture with pembrolizumab for 1L PD-L1-positive NSCLC, and as a monotherapy for 1L TNBC.

Medical progress within the reporting interval:

• Advertising approval for 2L+ HR+/HER2- BC
• New indication drug functions accepted for 1L TNBC and 1L PD-L1-positive NSCLC
• The OptiTROP-Lung06 registrational trial in China for 1L PD-L1-negative non-squamous NSCLC met main endpoint
• The worldwide Section 3 TroFuse-005 trial for 2L+ EC met main endpoints
• Two world Section 3 trials for OC & UC initiated in H1 2026
• Section 2 research together with SKB118 for NSCLC initiated
• Granted BTD for 1L PD-L1-positive NSCLC from NMPA

Drawing on all of the aforementioned key advances, sac‑TMT has clearly embodied 4 core improvement methods: advancing from monotherapy to combo-therapy, shifting from later-line to earlier-line therapy settings, increasing indications, and conducting medical analysis from China to the worldwide.

Trastuzumab botidotin (HER2 ADC, often known as A166) (舒泰莱^®)
One indication has acquired advertising and marketing approval for the therapy of 2L+ HER2+ BC. Its Section 2 medical research in HER2+ BC sufferers beforehand handled with topoisomerase inhibitor ADCs is ongoing.

Different ADC and novel DC property

The Firm has additionally constructed a pipeline of modern property which are differentiated from and complementary to accredited ADCs in indications, efficacy and security profile, together with SKB315 (CLDN18.2 ADC), SKB410 (Nectin-4 ADC), SKB571 (novel bsADC), SKB107 (RDC), SKB103 (TAA-IO bsADC), and SKB565 (novel dual-payload ADC), amongst others.

Non-DC Belongings

Medical progress within the reporting interval:
SKB118/CR-001 (PD-1/VEGF bsAb): The IND utility for the therapy of strong tumors has been accredited by the NMPA, and a Section 1/2 medical trial is ongoing.
SKB378/WIN378 (TSLP mAb): A Section 1 medical trial in wholesome topics has been accomplished in China, and its IND utility for the therapy of COPD has additionally been accredited by the NMPA.
SKB575 (TSLP/undisclosed goal bsAb): Section 1 medical trials for atopic dermatitis and bronchial asthma are ongoing in China.

Main Key Analysis Findings Offered at Worldwide Educational Conferences & Journals

• The Section 3 trial evaluating sac-TMT plus pembrolizumab versus pembrolizumab monotherapy for first-line therapy of PD-L1-positive superior NSCLC was delivered as an oral presentation at ASCO 2026 and concurrently revealed in The Lancet. In contrast with single-agent immunotherapy, this mixture routine yielded a big prolongation in PFS (HR = 0.35), with constant PFS advantages noticed throughout all predefined subgroups; an OS profit pattern was additionally noticed (HR = 0.55).
• The ultimate OS evaluation outcomes from the pivotal research of sac-TMT for 3L EGFR-mutant NSCLC had been chosen as a LBA at ELCC 2026 and introduced as a mini oral presentation.
• Lunbotinib Fumarate Capsules (RET inhibitor, often known as A400/EP0031) (宁泰莱^®[1]): Key Section 2 medical outcomes for superior RET fusion-positive NSCLC had been introduced in an oral presentation at ASCO 2026.

A number of merchandise acquire market traction, with strong industrial progress momentum

Up to now, the Firm has acquired advertising and marketing authorization for sac-TMT (佳泰莱^®), tagitanlimab (科泰莱^®), Cetuximab N01 (达泰莱^®) and trastuzumab botidotin (舒泰莱^®), of which 3 merchandise masking 5 indications have been included within the Nationwide Reimbursement Drug Record (NRDL). The Firm has additionally submitted an NDA for Lunbotinib Fumarate Capsules, and upon regulatory communication and advertising and marketing approval, commercialization is predicted to start within the first half of 2027. With this, the Firm’s preliminary industrial product portfolio, comprising 5 merchandise, has taken form.

Within the first half of 2026, the entire income from gross sales of pharmaceutical merchandise reaching RMB 657 million, up by 112% in comparison with the identical interval final 12 months.

Main progress drivers:

Skilled Recognition of Excessive‑High quality Medical Information and Shift in Therapy Paradigms:

• Information from plenty of excessive‑high quality medical research of worldwide caliber have continued to be launched, thereby constantly reinforcing the evidence-based medical basis of our merchandise.
• Acknowledged via authoritative endorsement from medical guideline consultants, as mirrored in pointers (CSCO, and so on.) and medical knowledgeable consensus.
• 佳泰莱^® is acknowledged because the “customary of care in 2L and the popular routine in 3L” within the LC, and can also be the popular model amongst TROP2 ADC in TNBC.
• By ongoing medical schooling and tutorial change actions, clinicians have gained a deeper understanding of the merchandise. Therapy paradigms have additionally advanced step by step.

Complete Enhancement of Drug Accessibility

• Efficient translation of the advantages of NRDL inclusion: 3 indications of 佳泰莱^® and 达泰莱^® have been included within the 2025 NRDL, which formally took impact on January 1, 2026. This marks 佳泰莱^® the solely TROP2 ADC and the solely home ADC in TNBC/NSCLC beneath the NRDL
• Broader hospital entry channels: Covers 30 provinces, over 300 prefectures and over 2,000 hospitals; Broaden reimbursement channels, together with formal entry, short-term procurement and dual-channel reimbursement;
• Steady enlargement of the commercialization group: Established a group of 800+; almost doubling YoY; Achieved in depth grassroots protection of top-tier hospitals in high-potential districts

Sac-TMT (佳泰莱^®) achieved optimistic ends in its first world Section 3 trial, accelerating world collaboration progress

• Collaboration with Merck Sharp & Dohme (hereinafter known as the “MSD”) (默沙东): MSD has initiated 17 ongoing Section 3 world medical research of sac-TMT as a monotherapy or together with pembrolizumab or different brokers for a number of kinds of most cancers, with indications masking breast most cancers (BC), lung most cancers (LC), gynecologic cancers, gastrointestinal (GI) cancers, and genitourinary (GU) cancers.
  In Could 2026, MSD introduced that the pivotal Section 3 Trofuse-005 trial met its main endpoints of OS and PFS in sure sufferers with superior or recurrent EC. TroFuse-005 is the primary world Section 3 trial to display statistically vital enchancment in each OS and PFS in comparison with chemotherapy for these sufferers, and sac-TMT is the primary and solely ADC to take action for sufferers with EC on this setting.
  Past sac‑TMT, the Firm has additionally entered into collaborations with MSD on sure ADC property, constantly exploring the optimum ADC pipeline portfolio.
• Collaboration with Ellipses Pharma: Lunbotinib Fumarate Capsules (A400/EP0031) have acquired FDA approval to proceed into Section 2 medical improvement. A complete of 42 medical trial websites has been established in america, UK, Europe, and the United Arab Emirates for Lunbotinib Fumarate Capsules.
• Collaboration with Windward Bio: Windward Bio is evaluating SKB378/WIN378 within the POLARIS Section 2/3 world trial in sufferers with bronchial asthma and has dosed the primary sufferers within the SIRIUS Section 2 world research in sufferers with COPD.
• Collaboration with Crescent Biopharma: Entered right into a licensing collaboration with Crescent Biopharma for SKB105/CR-003.

ESG capabilities proceed to strengthen, delivering excellent ends in capital market efficiency.

By way of ESG, in Could 2026, the Firm was included within the “China ESG Affect Record” by Fortune and was awarded bronze medal for “Most Dedicated to ESG (China)” beneath “Asia’s Greatest Firm” by FinanceAsia. In March 2026, the Firm had acquired a ranking of “AA” within the MSCI ESG Ranking Evaluation.

By way of capital markets, the Firm was accredited by the Hong Kong Inventory Alternate to formally take away the “B” marker from its inventory code on April 14, 2026. As well as, the Firm accomplished the putting of H Shares in July 2026, with web proceeds from the Putting amounting to roughly HK$2,723.4 million.

Prospect

Kelun-Biotech will proceed to drive innovation and strengthen its operational capabilities, steadily advancing in the direction of changing into a world-class biopharmaceutical firm. Particularly, the Firm will implement the next improvement methods: advancing differentiated pipelines concentrating on indications with vital medical wants; optimizing payload-linker methods and novel DC designs and buildings, whereas increasing functions in non-oncology ailments; enhancing its end-to-end drug improvement and commercialization capabilities; increasing its world footprint via strategic partnerships and enhance our capabilities for the event, registration and commercialization of our merchandise in ex-China market; and optimizing its operational programs with the intention of changing into a number one world biopharmaceutical firm.

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About Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and world collaboration of modern organic medication and small molecule medication. Kelun-Biotech focuses on main illness areas reminiscent of strong tumors, autoimmune, and metabolic ailments, and in establishing a globalized drug improvement and industrialization platform to deal with the unmet medical wants in China and the remainder of world. Kelun-Biotech is dedicated to changing into a number one world enterprise within the discipline of modern medication. At current, Kelun-Biotech has greater than 30 ongoing key modern drug initiatives, of which 4 initiatives with 8 indications have been accredited for advertising and marketing, 2 initiatives with 3 indications are within the NDA stage and greater than 10 initiatives are within the medical stage. Kelun-Biotech has established one of many world’s main proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC initiatives with 5 indications accredited for advertising and marketing, and a number of ADC and novel DC property in medical or preclinical analysis stage. For extra data, please go to https://en.kelun-biotech.com/.