Sichuan Biokin Pharmaceutical Co., Ltd.

Swiss biotech Windward Bio is picking up a second drug candidate from a China biotech this year, seeking to bring multiple medicines to market for respiratory and dermatology conditions. Windward is paying up to $700 million to gain access to a TSLP and IL-13 bispecific antibody from Qyuns Therapeutics. The partners declined to disclose the upfront size of the deal but said Qyuns gets an equity stake in Windward. Qyuns’ other bispecific antibody pact this year with Roche came with $70 million upfront. Taizhou-based Qyuns is in Phase 1 testing with the asset at the heart of Monday’s deal , which marked the third China-to-Europe drug licensing transaction of the day. AstraZeneca and Ipsen also took part in the growing trend. Windward expects to take Qyuns’ injectable, named QX027N/WIN027, into a Phase 1b in patients with respiratory and dermatology conditions once it has collected the Phase 1 data, CEO Luca Santerelli told Endpoints News on Monday. The biotech is betting that WIN027 has potential across asthma, COPD and atopic dermatitis, and it aims to get to quarterly or twice-yearly dosing with the long-acting medicine. “We scoped the whole landscape for potential best-in-disease, best-in-class products that we could get our hands on, and we identified this Qyuns molecule as such a possibility,” Santarelli said. “We came across this molecule maybe 10 months ago, and we worked very hard to get it in.” The agreement marks a quick progression for Windward, which launched with $200 million in January and rights to a TSLP antibody from Kelun and its partner Harbour BioMed. Since then, Windward has brought the asset from that first deal into a Phase 2 trial in asthma patients. The drug, dubbed WIN378, will also be tested in patients with COPD next year, Santarelli said. Windward plans to file WIN378 for regulatory approval in asthma by 2031 and COPD by 2032, if all goes to plan, the CEO said. They’ll also look for a commercialization partner for that treatment. Santarelli declined to disclose Windward’s runway but said the 30-employee startup doesn’t need a capital injection at the moment. The biotech expects eight clinical readouts over the next two and a half years, and those data drops can drum up investor intrigue for future financings, he said. Its financial backers include OrbiMed, Novo Holdings and Qiming. The Windward executive team comprises the former C-suite of VectivBio. Santarelli sold that gastrointestinal biotech to Ironwood Pharmaceuticals for $1 billion in 2023. Ironwood had expected to get FDA approval for the main drug from that acquisition, but ran into a regulatory setback in April and now anticipates starting a confirmatory trial next year. Windward will have to compete with some large pharmaceutical companies and small biotechs in the TSLP and TSLPxIL-13 bispecific landscape. Amgen and AstraZeneca market a monthly TSLP biologic called Tezspire. Tezspire sales jumped 40% year over year to $377 million in the third quarter, Amgen said last month. Meanwhile, GSK paid $1 billion upfront for Aiolos Bio in January 2024. Generate:Biomedicines is slated to enter Phase 3 and Upstream Bio has also presented mid-stage data . Multiple drugmakers are also attempting to take a TSLPx-IL-13 bispecific onto the market. Sanofi’s lunsekimig is in Phase 3 in COPD, and Johnson & Johnson snagged an asset in this area as part of its $850 million Proteologix acquisition in 2024. Santarelli said blocking TSLP should have the “biggest effect size” for respiratory diseases. By adding IL-13, “it adds certain aspects to the respiratory biology.” The target is thought to contribute to the formation of mucus plaque in the lungs of COPD and asthma patients, he added. Beyond the two China-derived assets, Windward is also working on an internally discovered bispecific that goes after less-validated targets, Santarelli said. “We’re committed to continue to grow the company,” the CEO said. “We’re not stopping at three molecules.”

CANTANHEDE, Portugal, Dec. 22, 2025 /PRNewswire/ -- Mondego Bio, a clinical-stage biotechnology company developing next-generation small-molecule immuno-oncology therapies, today announced the formal selection of its lead clinical candidate, ZE00-0388, a highly selective inhibitor of PTPN2. Candidate nomination follows completion of an extensive preclinical evaluation package demonstrating a favorable safety and tolerability profile in relevant animal models. With this milestone, Mondego Bio is transitioning into clinical-stage operations and plans to initiate a first-in-human (FIH) Phase 1 clinical study in the first half of 2026. The planned clinical program is designed to characterize initial safety, tolerability, and pharmacokinetics, while enabling exploratory translational assessments in oncology. The Phase 1 study is expected to include a dual-track design, consisting of a healthy volunteer cohort intended to assess safety, tolerability, and pharmacokinetics to inform dose selection and exposure characterization, and oncology patient cohorts designed to explore the safety, tolerability, and pharmacologic profile of ZE00-0388 when administered as monotherapy and in combination with immune checkpoint inhibitors, with evaluation of selected biomarkers in patients with solid tumors. "The selection of ZE00-0388 marks a pivotal transition for Mondego Bio from discovery into clinical development," said Nikolay Savchuk, PhD, Chief Executive Officer of Mondego Bio. "Our preclinical data support a disciplined and measured entry into the clinic. By selectively targeting PTPN2, we aim to investigate its potential role in modulating immune signaling pathways, including in combination with established immuno-oncology approaches." ZE00-0388 is an AI-designed, highly selective small-molecule inhibitor of PTPN2 (Protein Tyrosine Phosphatase Non-Receptor Type 2), an intracellular regulator of cytokine and interferon signaling. PTPN2 acts as a negative regulator of the JAK–STAT pathway and has been implicated in mechanisms of immune regulation within the tumor microenvironment. Preclinical studies suggest that modulation of PTPN2 activity may influence interferon signaling and immune cell function, supporting further clinical investigation in oncology settings. Advancement of ZE00-0388 into clinical development is supported by the Company's recent Series A financing, led by Biovance Capital, with participation from OrbiMed and Torrey Pines Investment. About Mondego Bio Headquartered in Biocant Park in Cantanhede, Portugal, Mondego Bio is a biotechnology company focused on developing next-generation small-molecule therapies for oncology. The Company was incubated through the AI- and machine-learning–driven discovery platform of Expert Systems, in collaboration with Eilean Therapeutics and Molsoft LLC. Mondego Bio integrates rational design, computational pharmacology, and medicinal chemistry expertise to target intracellular regulators relevant to immune modulation and cancer biology. For more information, visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of applicable securities laws, including statements regarding the initiation, timing, design, and conduct of planned clinical studies; the potential safety, tolerability, and pharmacologic profile of ZE00-0388; the evaluation of ZE00-0388 in combination with immune checkpoint inhibitors; and Mondego Bio's development plans and strategic objectives. Forward-looking statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others, uncertainties inherent in drug discovery and development, clinical trial execution and outcomes, regulatory review processes, and the availability of capital. Mondego Bio undertakes no obligation to update any forward-looking statements except as required by law. Media Contact Rita Santos, PhD Director, External Relations [email protected] SOURCE Mondego Bio 21% more press release views with Request a Demo

Insilico planted its flag in AI drug design by finding a new target for idiopathic pulmonary fibrosis, designing a novel molecule to match, and readying it for human testing within 18 months, all at a price of $2 million. \n After reportedly flirting with going public for years, the artificial intelligence-powered drug developer Insilico Medicine has laid out plans to raise about $292 million through a listing on the Stock Exchange of Hong Kong.The company plans to put up a total of more than 94 million shares—with about 10% offered in Hong Kong and the remainder placed internationally—priced at 24.05 per share in Hong Kong dollars, or about $3.09 U.S. apiece.The IPO—scheduled to run through Dec. 23, with trading starting Dec. 30—will wrap up a year that saw Insilico raise $110 million through a March venture capital round and ink multiple R&D deals with global drugmakers, including a recent pact with Eli Lilly potentially worth more than $100 million. Insilico has long maintained an office in Hong Kong, and also counts outposts in Shanghai and Taipei, as well as Boston, New York, Montreal and Abu Dhabi. Since its 2014 founding, the former Fierce Medtech Fierce 15 and Fierce 50 winner has employed generative AI programs to help design molecules into potential drugs across a variety of diseases for its Big Pharma customers, as well as for its own internal research pipeline focused on fibrosis and longevity.The company’s Pharma.AI platform spans target identification, small-molecule generation, and the prediction of clinical outcomes. Insilico also aims to bring more automation to laboratories, boosting their throughput in examining the countless compounds that AI can provide. This past February, Insilico published benchmarking timelines from 22 of its AI-designed drug candidates, which on average took about 13 months from the initial building of a large library of potential molecules through the whittling down to a chosen few for synthesis, testing and finally selection for clinical trials.  Prior to that, Insilico planted its flag in 2021 by identifying a new biological target linked to idiopathic pulmonary fibrosis, or IPF, designing a novel molecule to match and completing preclinical experiments, readying it for human testing all within a span of 18 months. The company reported a price tag of about $2 million for this work, a dramatic cut from traditional drug discovery costs.Now serving as the company’s lead internal candidate, rentosertib has cleared early safety studies in IPF and has shown improvements in lung function through a phase 2a placebo-controlled trial of 71 participants conducted in China. Formerly known as ISM001-055, the molecule represents a potentially first-in-class TNIK inhibitor. The study’s results were published this past June in Nature Medicine. In 2026, Insilico plans to examine rentosertib in a kidney fibrosis clinical trial, as well as in an inhalable formulation for the treatment of IPF.  In its prospectus (PDF) filed with the Hong Kong exchange, the company reported $85.8 million in revenue for the 2024 calendar year, with a net loss of $17.4 million. For the first six months of 2025, revenue and losses totaled $27.5 million and $18.9 million, respectively.In terms of venture capital, Insilico has raised more than $500 million to date, with backers including Warburg Pincus, Qiming Venture Partners, WuXi AppTec, B Capital Group, Prosperity7, OrbiMed, Deerfield, Pavilion Capital, PIDC, CPE fund, Mirae Asset Capital, Lilly Asia Ventures, Eight Roads, Lake Bleu Capital, Baidu Ventures and Sinovation Ventures. Its $110 million series E round this year was led by the Hong Kong-based firm Value Partners.