Two major clinical advances announced within two days: HBM Therapeutics drives dual growth in oncology and autoimmune disease

On June 10, HBM Therapeutics (HKEX: 02142) announced that China’s National Medical Products Administration (NMPA) has formally accepted its Investigational New Drug (IND) application for HBM7004—a novel B7H4×CD3 bispecific antibody—for the treatment of advanced solid tumors. Key milestones This marks another critical milestone following the U.S. FDA’s IND clearance for HBM7004 on May 8, signifying the official launch of simultaneous clinical development in both China and the U.S. HBM7004 was developed using HBM’s proprietary HBICE® platform. It targets B7-H4—a protein highly expressed in multiple solid tumors including triple-negative breast cancer and ovarian cancer, yet restricted in normal tissues—and redirects T cells via CD3 to achieve tumor-selective killing. Preclinical data demonstrate robust antitumor efficacy, excellent in vivo stability, low systemic toxicity, and pronounced synergistic effects when combined with a B7H4×4-1BB bispecific antibody. Just one day earlier, on June 9, the company announced that the first patients had been dosed in the Phase II SIRIUS study evaluating HBM9378/WIN378—a fully human, ultra-long-acting anti-TSLP antibody—for moderate-to-severe chronic obstructive pulmonary disease (COPD). Co-developed by HBM Therapeutics and Kelun-Biotech, this molecule underwent half-life extension engineering. Phase I clinical data confirmed its feasibility for subcutaneous administration just twice per year, with an exceptionally low incidence of anti-drug antibodies. Currently, HBM9378/WIN378 is also being evaluated in the Phase II/III POLARIS study for moderate-to-severe asthma; preliminary data are expected in the second half of 2026, and the first Phase III asthma trial is scheduled to commence in Q4 2026. In January 2025, Windward Bio acquired exclusive global rights to this asset—excluding Greater China and certain Asian countries—for up to $970 million. The near-simultaneous achievement of milestone events for two highly differentiated candidates is rare among domestic biotech companies. These two programs span the two most promising therapeutic areas—oncology and autoimmune diseases—and both were built upon HBM’s proprietary fully human antibody platforms, eliminating immunogenicity risks associated with non-human sequences. Staggered clinical development timelines effectively smooth out capital expenditure requirements and mitigate operational volatility arising from potential setbacks in any single program. Platform foundation HBM Therapeutics’ consecutive breakthroughs stem from its highly differentiated foundational technology platforms. Leveraging the Harbour Mice® fully human antibody platform (H2L2 + HCAb), the HBICE® immune cell engager platform, and the Hu-mAtrIx™ AI model, the company has established an end-to-end R&D engine—from target discovery to clinical translation. By end-2025, HBM had entered three deep collaborations with AstraZeneca—including a multi-target co-discovery and co-development agreement valued at up to $4.575 billion, plus a $105 million equity investment—and maintained long-term, stable partnerships with global pharma leaders including Bristol Myers Squibb (BMS), Pfizer, and Otsuka. In terms of its product pipeline, HBM has established a three-tiered structure: late-stage commercial candidates, mid-stage clinical assets, and early-stage discovery candidates. Beyond HBM7004 in oncology, the portfolio includes HBM4003—a fully human CTLA-4 heavy-chain antibody (in Phase II combination with PD-1); HBM9027—a PD-L1×CD40 bispecific antibody (IND approved); HBM7022—a CLDN18.2×CD3 bispecific antibody (licensed to AstraZeneca); and HBM9033—a MSLN-ADC (licensed to Pfizer).

Domestic autoimmune NewCo boom: the next blockbuster acquisition emerges

Almost simultaneously, another NewCo with similar characteristics—Windward Bio—completed a $165 million cross-round financing. Its two core TSLP assets, WIN378 and WIN027, likewise trace their technological origins to HBM Therapeutics, Kelun-Biotech, and Qixin Biologics. From Kailera and Yarrow’s IPOs to Ouro and Candid’s acquisitions, a compelling new trend is now emerging in the cross-border BD market: assets spun out from Chinese biopharmas via the NewCo model are becoming the ‘royal road’ onto multinational corporations’ (MNCs) acquisition shortlists. ‘Chinese seeds, overseas soil, global harvest’—this higher-efficiency value-creation pathway is catalyzing market anticipation of the next blockbuster NewCo acquisition. Windward Bio has already drafted its own ‘for-sale’ profile on the capital markets. 01 Windward Bio enters the ‘to-be-acquired’ list Looking back at Candid’s ascent: through acquisitions of TRC 2004 and Vignette Bio, Candid integrated two T-cell engager (TCE) pipelines and precisely targeted the high-potential ‘TCEs for autoimmune diseases’ space. Its lead asset, Cizutamig—a BCMA/CD3 TCE considered a potential best-in-class candidate in autoimmune indications—derives its ‘technological lineage’ from ImmuneOnco (Yimeng Bio). While its cytotoxic profile was originally observed in multiple myeloma (MM), that same mechanism translates into a ‘deep depletion of pathogenic B cells’ in autoimmune settings. Candid has accumulated clinical evaluations across more than 100 MM and autoimmune patients and is advancing studies across over ten autoimmune indications. Another CD20/CD3 TCE candidate, CND261, originated from TRC 2004—a NewCo jointly established by Two River and Third Rock Ventures—with core technology licensed from Genor Biopharma. In addition, Candid has forged R&D collaborations with ImmuneOnco, Ab Studio, and Nona Biosciences, aiming to build a complementary, multi-specific TCE ‘combination punch’ targeting B-cell-mediated autoimmune diseases. UCB—a key player in immunology—backed this entire platform-driven strategy with a $2 billion upfront payment. This same incubation logic underpins Windward Bio’s development trajectory. Founded in January 2025 by international venture capital firms OrbiMed and Novo Holdings, Windward Bio has anchored itself in the autoimmune space—specifically respiratory and dermatological diseases—by focusing on the more de-risked, ‘pan-indication’ target TSLP. Positioned upstream in the type 2 inflammation cascade, TSLP has already been clinically validated by Tezspire in asthma. Its flagship program, WIN378—originating from Kelun-Biotech and HBM Therapeutics—features an ultra-long-acting design enabling just two subcutaneous doses per year, directly challenging current TSLP antibodies on dosing convenience. In a TSLP space where the mechanism is proven, assets remain suboptimally developed, and commercial opportunity remains vast, WIN378 already possesses a strong competitive edge over existing therapies.

Swiss drug developer Windward Bio files for US IPO

16 hours ago

Swiss biotech firm Windward Bio filed for a US IPO on Nasdaq to fund its pipeline of long-lasting antibody treatments for asthma and inflammatory diseases. The company secured up to $365 million from investors including Novo Holdings and Blue Owl Capital prior to listing.

reuters

2026-10-23

Swiss drug developer Windward Bio files for US IPO

Swiss drug developer Windward Bio files for US IPO

FAQ