Serplulimab

Angitia raises $130M to advance musculoskeletal drug pipelineLB Pharma brings in $100M in private placementEisai gains rights to Henlius' anti-PD-1 in JapanCVS drops Amgen, Lilly bone drugs from key formulariesAngitia raises $130M to advance musculoskeletal drug pipelineAngitia Biopharmaceuticals closed a $130-million series D financing to support the continued development of its pipeline of drugs for musculoskeletal diseases. The company's pipeline includes the three biologic product candidates — AGA2118, AGA2115 and AGA111 — in the clinic for the treatment of postmenopausal osteoporosis, osteogenesis imperfecta and spinal fusion. The funding round was co-led by Frazier Life Sciences and Venrock Healthcare Capital Partners, with new investors, including Ascenta Capital, BVF Partners, Logos Capital and RA Capital Management, joining existing backers, such as Bain Capital Life Sciences, OrbiMed and TF Capital.CEO David Ke noted that Angitia recently completed enrollment in the Phase II ARTEMIS trial in postmenopausal osteoporosis and started dosing in the mid-stage IDUN study in osteogenesis imperfecta.-Matthew DennisLB Pharma brings in $100M in private placementLB Pharmaceuticals is selling around 3.3 million shares for $21.17 a piece as part of a private placement that is expected to raise approximately $100 million. The funds will support a Phase II trial of the company's lead pipeline candidate, the benzamide antipsychotic drug LB-102, as an adjunctive treatment for major depressive disorder.The private placement comprised new and existing investors, including Balyasny Asset Management, Caligan Partners, Commodore Capital, Deep Track Capital, Nantahala Capital, Pivotal bioVenture Partners, Spruce Street Capital, TCGX and Trails Edge Capital Partners.-Matthew DennisEisai gains rights to Henlius' anti-PD-1 in JapanEisai licensed Japanese rights to Henlius Biotech's anti-PD-1 antibody serplulimab under a deal potentially worth more than $388 million. Serplulimab is already approved in China under the name Hansizhuang and in the EU as the brand Hetronifly for the treatment of various forms of lung cancer.Henlius is currently conducting a Japanese Phase II bridging study of serplulimab in extensive-stage small-cell lung cancer, with plans to submit a marketing application in fiscal year 2026 that will also include Phase III data that supported approvals in China and Europe. "We anticipate that it will also become a promising treatment option in Japan for…non-MSI-high metastatic colorectal cancer, for which development is under way," said Toshihiko Yusa, head of Eisai's Japan business unit.As part of the deal, Eisai will make a $75-million upfront payment, along with regulatory milestones of up to $80.01 million and sales milestones of up to $233.3 million. In addition, Henlius is eligible to receive double-digit royalties on sales of the product in Japan.-Matthew DennisCVS drops Amgen, Lilly bone drugs from key formulariesCVS Health will remove two osteoporosis drugs — Amgen's Prolia (denosumab) and Eli Lilly's Forteo (teriparatide) — from certain preferred drug lists, replacing them with biosimilars and generics beginning April 1.Through its pharmacy benefit manager CVS Caremark, the company will add Prolia biosimilars such as Ospomyv, sold by CVS unit Cordavis, and Celltrion's Stoboclo, alongside generic teriparatide options Bonsity and Tymlos, to major national commercial template formularies. "This preferred biosimilar approach is over 50% lower in costs per prescription than the original brand," CVS said.The move follows the expiration of key US patents for Prolia in 2025 and the earlier loss of primary patents for Forteo in 2019. The formulary change also builds on CVS's decision in 2024 to exclude AbbVie's Humira (adalimumab) in favour of biosimilars.-Anna Bratulic

TOKYO and SHANGHAI, Feb. 5, 2026 /PRNewswire/ -- Eisai Co., Ltd. ("Eisai") and Shanghai Henlius Biotech, Inc. ("Henlius") today announced the conclusion of an exclusive commercialization and co-exclusive development and manufacturing license agreement for the anti-PD-1 antibody serplulimab (generic name; marketed as Hetronifly® in the EU) in Japan. Serplulimab is a novel anti-PD-1 monoclonal antibody developed by Henlius and reported to have a unique binding mode distinct from existing anti-PD-1 antibodies. In China, it has been approved for multiple indications, including squamous non-small cell lung cancer, extensive-stage small cell lung cancer (ES-SCLC), non-squamous non-small cell lung cancer, and esophageal squamous cell carcinoma. In the EU, serplulimab has been approved for ES-SCLC and is the world's first anti-PD-1 antibody approved as a first-line treatment for this indication. In Japan, Henlius is currently conducting a Phase II bridging study for ES-SCLC and plans to submit a regulatory application in fiscal year 2026 based on the bridging study results and Phase III data supporting approvals in China and Europe. In addition, a Phase III multinational clinical trial for non-MSI-High metastatic colorectal cancer is ongoing, with further development in additional indications planned. Under the agreement, Eisai will obtain exclusive rights to commercialize serplulimab in Japan. Henlius plans to conduct a clinical trial for perioperative gastric cancer in Japan and will assume the responsibilities of the Marketing Authorization Holder. Eisai will pay Henlius an upfront payment of USD 75 million, regulatory milestone payments of up to USD 80.01 million, and sales milestone payments of up to USD 233.3 million. In addition, Henlius will receive double-digit royalties based on product sales. Eisai expects no impact on its consolidated financial forecast for the fiscal year ending March 31, 2026. "We are pleased to collaborate with Eisai in Japan to advance the development of serplulimab in this important market," said Dr. Jason Zhu, CEO of Henlius. "By combining Henlius' innovation capabilities with Eisai's strong local expertise, we aim to support efficient development and address unmet medical needs for patients in Japan." "Serplulimab has already demonstrated its potential in indications with significant unmet medical needs and has obtained approvals in China and the EU," said Toshihiko Yusa, Executive Officer and Head of Japan Business at Eisai. "Eisai will work closely with Henlius to deliver serplulimab to patients in Japan as quickly as possible." 21% more press release views with Request a Demo