DualityBio Therapeutics Inc (DualityBio) has had its application for an initial public offering on the Shanghai Stock Exchange's STAR Market accepted.
The company's listing sponsor is China Securities, and it aims to raise approximately 4.1 billion yuan.
DualityBio Therapeutics Inc is a global innovative biopharmaceutical company with a deep focus on the antibody-drug conjugate (ADC) field, aspiring to become a leader in the global ADC sector.
As of the signing date of the prospectus, the company has built a tiered product portfolio containing 10 clinical-stage assets. It is conducting 10 global multi-center clinical trials in approximately 20 countries, with a cumulative enrollment of over 3,500 patients, about 50% of whom are from overseas.
Among these, the new drug application for the HER2+ breast cancer indication of DB-1303 (a HER2 ADC) has been accepted by the National Medical Products Administration. Enrollment for the global Phase III clinical trial for HER2 low-expression breast cancer has been completed, placing its global progress in a leading position among similar HER2 ADCs.
DB-1311 (a B7-H3 ADC) has entered the global Phase III clinical trial stage, making it the most advanced domestic B7-H3 ADC for prostate cancer and one of only two B7-H3 ADCs globally to have reached Phase III trials in this area.
Regarding external collaborations, DualityBio Therapeutics Inc has established multiple landmark partnerships with global industry leaders such as BioNTech, GSK, BeiGene, 3SBio, Avenzo, and Adcendo. The total potential transaction value exceeds $6 billion, including upfront payments, staged milestone payments, and provisions for royalty-based revenue streams.
The company also holds rights for cost and profit/loss sharing and a co-promotion option for DB-1311 in the United States.
The company's products have demonstrated breakthrough therapeutic potential in clinical trials, having so far received one FDA Breakthrough Therapy designation, one NMPA Breakthrough Therapy designation, five FDA Fast Track designations, and two FDA Orphan Drug designations.
Specifically, DB-1303 has simultaneously received FDA Breakthrough Therapy and Fast Track designations, as well as an NMPA Breakthrough Therapy designation for HER2-expressing endometrial cancer. It has the potential to become the first HER2 ADC globally to cover all HER2 expression levels (IHC 1+/2+/3+) in endometrial cancer.
DB-1303 is also currently the second HER2 ADC globally to successfully enter global Phase III registration clinical trials for the HER2 low-expression breast cancer population (chemotherapy-naïve).
DB-1311 has received FDA Fast Track designation and has shown promising clinical efficacy and manageable safety in multiple difficult-to-treat solid tumors, including metastatic castration-resistant prostate cancer, platinum-resistant ovarian cancer, and advanced cervical cancer. It has the potential to be among the first globally approved B7‑H3 ADC drugs covering multiple cancer types.
DB‑1311 is also a significant product globally that can comprehensively challenge first-line/second-line standard treatments and directly compete with leading global B7‑H3 ADCs.
As of the prospectus signing date, leveraging its four proprietary ADC technology platforms, DualityBio Therapeutics Inc has established a structurally complete, globally oriented innovative drug pipeline targeting HER2, B7‑H3, HER3, TROP2, BDCA2, B7-H3×PD-L1, EGFR×HER3, among others.
Several of its products are positioned in the global first tier of development for key cancer types and specific indications, possessing potential for first-in-class or best-in-class status.
Financially, for the 2023, 2024, and 2025 fiscal years, the company reported operating revenues of approximately 1.787 billion yuan, 1.941 billion yuan, and 1.852 billion yuan, respectively.
During the same periods, its R&D expenditure as a percentage of operating revenue was 29.54%, 39.16%, and 44.81%, respectively.
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