Denosumab-dssb

Shanghai Henlius Biotech (HKEX: 2696) and Sandoz (SIX: SDZ; OTCQX: SDZNY) expanded their biosimilars collaboration into a platform-level agreement covering up to 10 monoclonal antibody (mAb) and antibody-drug conjugate (ADC) biosimilar assets, with payments for the initial tranche potentially reaching USD 322 million and up to USD 100.5 million expected to be invoiced in 2026. The agreement names three confirmed licensed assets — HLX05-N, a proposed cetuximab biosimilar currently in Phase I; HLX16, a proposed evolocumab biosimilar in preclinical research; and an unnamed belimumab biosimilar also at preclinical stage — plus a non-refundable option on HLXTE-HAase1001, a recombinant human hyaluronidase described by Henlius as intended to enable subcutaneous co-formulation of biologics. Henlius said the total invoiced amount expected in 2026 is up to USD 100.5 million. The deal expands a relationship that began in April 2025 when the two companies entered an exclusive commercialization agreement for HLX13, Henlius' proposed ipilimumab biosimilar, covering 46 countries including the US and Europe for USD 31 million upfront and up to USD 270 million in milestones. That deal has since advanced to patient dosing in the US in an international multicenter Phase I study. The platform agreement follows within 16 months, potentially indicating growing confidence in Henlius as a development and manufacturing partner, while Henlius' pertuzumab injection passed GMP compliance inspection in June 2026. Under the structure, Henlius retains responsibility for development, manufacturing, and supply of all partnered products, as well as all China rights. Sandoz receives exclusive ex-China commercialization rights, with geographic scope varying by asset: HLX05-N carries exclusive rights in the US, Canada, EU, UK, Switzerland, Japan, Australia, and New Zealand, with semi-exclusive rights in certain Asian markets; HLX16 and the belimumab biosimilar carry worldwide ex-China exclusivity. The parties describe the arrangement as a co-development-informed model, with Sandoz contributing ex-China market and regulatory input from early development stages. The option on HLXTE-HAase1001 is structurally distinct from the three licensed assets. Recombinant hyaluronidase functions as an enabling technology for subcutaneous drug delivery rather than a standalone therapeutic — an approach analogous to Halozyme's ENHANZE platform. Henlius received National Medical Products Administration (NMPA) investigational new drug (IND) approval for a related hyaluronidase program in March 2026. An option for this class of asset embedded within a biosimilar supply deal is atypical and would give Sandoz a potential subcutaneous formulation capability applicable beyond Henlius-sourced products. The reference markets for the three initial therapeutic assets are substantial: cetuximab generated approximately USD 1.696 billion in global sales in 2025, evolocumab approximately USD 6.602 billion, and belimumab approximately USD 2.475 billion, according to IQVIA data cited by Henlius. HLX05-N is the most clinically advanced, having dosed its first patient in a Phase I study in China in July 2026 after receiving NMPA Phase I approval in April 2026. Henlius has executed a consistent multi-partner, ex-China out-licensing strategy across its biosimilar pipeline. It licensed HLX15, a daratumumab biosimilar, to Dr. Reddy's for Europe and the US in February 2025, and entered a serplulimab commercialization agreement with Eisai for Japan in February 2026. Its earlier partnership with Organon for pertuzumab and denosumab biosimilars has yielded commercial launches, including the Canadian denosumab biosimilar launch in June 2026. Across all deals, Henlius has retained China rights — a structural constant in its out-licensing model. Sandoz has assembled a parallel sourcing network across Asian biosimilar developers, having also partnered with Samsung Bioepis on up to five biosimilars and with EirGenix on a pertuzumab biosimilar valued at up to USD 152 million. The Henlius platform deal is the broadest in scope of these arrangements. The USD 322 million ceiling for the initial four assets — against reference markets totaling over USD 10 billion in 2025 combined sales — reflects the heavily milestone-back-loaded economics typical of early-stage biosimilar licensing, where regulatory and patent timelines remain material variables. Access the AllSci platform to explore the science behind the news. Spot something wrong? Report an issue with this article

Samsung Bioepis reports revenue of 847.1 billion KRW and an operating profit of 230.6 billion KRW in the first half of 2026, recording 6% year-over-year growth Expanding direct commercialization in Europe to five products with the launch of OPUVIZ™ 40 mg/mL vial, a biosimilar to Eylea 1 (aflibercept) First to announce preliminary results from Phase 1, 3 clinical studies for SB27, a biosimilar candidate referencing Keytruda 2 (pembrolizumab) Samsung Epis Holdings continuing to secure next-generation growth engines through establishment of a global R&D hub in China INCHEON, Korea--(BUSINESS WIRE)-- #biosimilars --Samsung Epis Holdings (KRX: 0126Z0), an investment company dedicated to innovations in biopharmaceuticals and biotechnology, today announced its financial results for the second quarter and first half of fiscal year 2026. “We delivered solid first-half 2026 results, achieving 6% growth year-over-year. This performance demonstrates the resilience of our biosimilar portfolio in the global market," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We remain confident in our growth trajectory; increasing product demand in Europe and the US is expected to be reflected sequentially in the second-half results, which would result in steady business performance for the fiscal year.” Second Quarter and First Half 2026 Results – Samsung Bioepis Samsung Bioepis, a 100% owned subsidiary of Samsung Epis Holdings, recorded revenue of 847.1 billion KRW and an operating profit of 230.6 billion KRW in the first half of 2026. This represents an increase of 45.5 billion KRW (+6%) in revenue and 12.8 billion KRW (+6%) in operating profit compared to the same period last year. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); For the second quarter, the company recorded revenue of 392.2 billion KRW and an operating profit of 86.6 billion KRW; revenue and operating profit decreased by 8.8 billion KRW (-2%) and by 3.2 billion KRW (-4%) respectively compared to the same period last year. [Samsung Bioepis Earnings, KRW billion] H1’25 H1’26 YoY Change Q2’25 Q2’26 YoY Change Revenue 801.6 847.1 45.5 (+6%) 401.0 392.2 -8.8 (-2%) Operating Profit 217.8 230.6 12.8 (+6%) 89.8 86.6 -3.2 (-4%) Business Updates Samsung Bioepis has expanded direct commercialization in Europe to five products with the launch of OPUVIZ (aflibercept) 40 mg/mL vial in May 2026. In the US, the company has expanded its market presence with the introduction of OSPOMYV ® (denosumab-dssb). Furthermore, the company is expanding its commercial footprint in international markets, including Japan where it launched its first biosimilar product in May 2026 through partnership with NIPRO Corporation. The company also announced the expansion of its global development and commercialization agreement with Organon to commercialize PYZCHIVA ® (ustekinumab), a biosimilar referencing Stelara 3 (ustekinumab), in Canada. In June 2026, the company announced preliminary results from Phase 1 and Phase 3 clinical studies for SB27, a biosimilar candidate referencing Keytruda (pembrolizumab). Phase 1 study demonstrated pharmacokinetic (PK) equivalence between SB27 and Keytruda while Phase 3 study demonstrated equivalent objective response rate (ORR) at Week 24. Both studies are expected to be completed within 2026. SBE303, the company's first novel antibody-drug conjugate (ADC) candidate, entered the global Phase 1 clinical study in March. SBE303 is engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including urothelial cancer, lung cancer, and breast cancer. Nonclinical characterization of SBE303 was presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting in April, highlighting its anti-tumor efficacy, safety, tolerability pro a promising ability to work in combination with existing immuno-oncology therapies. Second Quarter and First Half 2026 Results – Samsung Epis Holdings Samsung Epis Holdings recorded consolidated revenue of 845.8 billion KRW and an operating profit of 149.3 billion KRW in the first half of 2026, reflecting non-cash accounting adjustments. For the second quarter, the company achieved revenue of 391.9 billion KRW and an operating profit of 58.8 billion KRW. Samsung Epis Holdings is stabilizing its business under the holding company structure based on the solid performance of its core subsidiary, Samsung Bioepis, and established its first overseas R&D base in China to strengthen its novel therapeutic development capabilities. Disclaimer This document contains ‘forward-looking statements’ regarding future expectations, projections, plans, and anticipation. ‘Forward-looking statements’ are matters that pertain to the Company’s future business and financial performance, and are subject to uncertainties such as trends in domestic and international financial markets, including but not limited to fluctuations in exchange rates and/or interest rates. ‘Forward-looking statements,’ by their nature, addresses matters that may be uncertain; actual results may be materially different from those expressed in this document. About Samsung Epis Holdings Co., Ltd. As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings aims to maximize corporate and shareholder value through proactive R&D and investment and optimize business strategies for its subsidiaries, Samsung Bioepis and Epis NexLab. Samsung Epis Holdings continues to embrace future challenges and drive innovation by identifying new growth drivers and strengthening global collaboration platforms, thereby laying a solid foundation for the continued growth of its subsidiaries. For more information about Samsung Epis Holdings, please visit: . About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit and follow us on LinkedIn and X . 1 Eylea is a trademark of Bayer AG 2 Keytruda is a trademark of Merck Sharp & Dohme. 3 Stelara is a trademark of Johnson & Johnson Corporation. Contacts Media Contact Anna Nayun Kim, nayun86.kim@samsung.com Yoon Kim, yoon1.kim@samsung.com