On April 15, DualityBio, a rising star in the ADC field, was officially listed on the HKEX, marking one of the most high-profile IPOs in recent years in Chapter 18A Biotech Companies. With an offering price range of HKD 94.60 to HKD 103.20 per share, the company's market capitalization is projected to reach HKD 7.868 billion to HKD 8.584 billion, raising a total of USD 210 million - the largest fundraising scale among Chapter 18A Biotech Companies since 2022. Its international placement saw 14.9 times over subscription, while dark pool trading surged by 80%. 15 cornerstone investors threw USD 65 million in bets, with global giants like BioNTech, Fullgoal Fund, and E Fund participating. This not only reflects DualityBio's intrinsic strength but also underscores the explosive potential of the ADC field in global pharmaceutical innovation.

Golden Age of the ADC field

Dubbed "biological missiles", ADC drugs can achieve the precision of targeted therapies and the potency of chemotherapy by using antibodies to lock onto tumor cells and release powerful chemotherapeutic drugs to achieve targeted killing. Since the first ADC drug was approved in 2000, the field has undergone multiple technological iterations, from early setbacks due to toxicity issues to recent "Three-in-One" breakthroughs in novel linkers, highly active payloads, and optimized antibody design. These advancements have solidified ADCs as a mainstream approach in oncology. Industry reports predict the global ADC market will surge from USD 10.8 billion to USD 34.3 billion by 2032, with a compound growth rate of 15.6%. China's market is outpacing all others, fueled by policy support and rising Chinese innovation capacity, which makes ADCs made in China increasingly rival multinational giants in target selection, clinical progress, and going-global partnerships.

DualityBio's rise aligns perfectly with this technological wave. Its core assets, DB-1303 (targeting HER2) and DB-1311 (targeting B7-H3), lead global clinical development. Taking DB-1303 as an example, its clinical development for HER2 low-expression breast cancer and endometrial cancer indications leads the global race. The company plans to submit a Biologics License Application (BLA) to the FDA in 2025, positioning it to potentially become the first ADC new drug made in China to secure approval. This milestone would allow DualityBio to stand out even within the crowded HER2-targeted landscape. Currently, approximately 40% of global ADC R&D focuses on HER2, but the majority targets high-expression populations. However, HER2 low-expression patients account for over 50% of breast cancer cases, underscoring immense market potential.

Why DualityBio?

The IPO frenzy signals both market optimism for the ADC field and a race for capital. Over the past three years, Chapter 18A Biotech Companies endured a winter, with over 30% of companies trading below IPO prices and 30 valued under HKD 2 billion. Valuations of innovative pharmaceutical companies are facing widespread downward pressure. DualityBio, leveraging its well-defined commercialization roadmap, high-barrier technology platform, and validated business development (BD) capabilities, has become synonymous with "certainty" in the eyes of investors. Its market capitalization at issuance has nearly tripled compared to its pre-IPO final funding round (USD 270 million), setting a record for valuation growth in Chapter 18A Biotech Companies and rebuilding market confidence in innovative drugs.

The ADC field's "Matthew Effect" is also intensifying. Among 3,100+ global ADC candidates, only 12% reach late-phase clinical trials, with dominance concentrated among leaders. DualityBio's seven clinical stage drugs include five with globally leading indication development timelines. This "multi-pipeline positioning" strategy mitigates R&D risks while strengthening bargaining power with Multi National Companies (MNCs). In contrast, many small-to-mid-sized biotech companies struggle due to single-pipeline failures or lack of partnerships. As industry reshuffle accelerates, DualityBio's first-mover edge grows ever more pronounced.

Industry Transformation: From Generic Formulation to Technology Export

DualityBio's IPO marks a pivotal shift for China's innovative pharmaceutical companies, from reliance on Chinese markets to integration into global R&D chains. Its core pipelines are conducting clinical trials simultaneously in China and the United States with DB-1303's global multicenter tests spanning 17 countries and 50% of patients recruited overseas. The data are directly applicable for FDA submissions. The collaboration between the United States and China not only enhances international recognition but also attracts collaborations with giants like BioNTech for combination therapies, sharing R&D costs while leveraging partnerships to penetrate into European and American markets.

However, globalization is no smooth path. The patent for Enhertu, a first-generation HER2 ADC drug, will expire in 2030, pressuring companies to accelerate innovation iteration amid generics competition. ADC production processes are complex, and DualityBio currently relies on contract manufacturing by WuXi Biologics, with in-house production capabilities yet to be proven. Additionally, the intensifying biotech competition between China and the United States and the FDA's tightening scrutiny of Chinese pharmaceutical companies add uncertainty to DB-1303's accelerated approval prospects. These challenges demand not only technological breakthroughs but also the construction of full-chain capabilities spanning R&D to manufacturing.

Future Tests: Commercialization Prowess and Industry Reshuffle 

While DualityBio's IPO has rebuilt market confidence in innovative drugs, its true trials are just beginning. Despite the popularity of the ADC field, commercialization remains a weak link. For example, RemeGen's Disitamab Vedotin, the first approved ADC drug made in China, generated only RMB 1 billion sales volume in 2024, far below the USD 4.5 billion revenue of DS-8201. DualityBio must now confront DS-8201's dominance and fend off competition from Chinese rivals like Kelun Biotech and Hengrui Pharmaceuticals, while proving the clinical value of its differentiated pipelines. For instance, the B7-H3 target, though novel, carries higher risks due to incomplete mechanism compared to established targets, and the long-term efficacy in HER2 low-expression patients remains unverified.

Capital, once obsessed with pipeline volume, now prioritizes clinical value. Among DualityBio's 12 pipelines, seven are in clinical stages, but R&D expenses accounted for 102% of revenue in 2024. Failure to prune ineffective pipelines promptly could strain its financials. Meanwhile, the industry reshuffle is accelerating. Data show that among 3,100+ global ADC candidates, only 12% reach late-phase clinical trials, with dominance concentrated among leaders. Though five of DualityBio's clinical stage drugs lead in development timelines, the company must reinforce in efficacy, safety, and cost control to avoid becoming a fleeting technological phenomenon.

Conclusion

The listing of DualityBio marks a milestone in the transformation from "capital-driven" to "technology-driven" for China's innovative pharmaceutical companies. Its success underscores the criticality of differentiated technologies, global collaboration, and clinical efficiency. However, its true future value will depend on whether it can translate lab data into tangible extensions of patient survival. For the broader Chapter 18A Biotech Companies, DualityBio's IPO may serve as a confidence booster, but the industry's "spring" will not arrive through a single case. Only sustained technological accumulation, rigorous clinical validation, and ecosystem-building will enable players to emerge victorious in this innovation marathon.

Source: Public reporting materials