YingEn Biotech (09606) has submitted its IPO application to the Shanghai Stock Exchange Science and Technology Innovation Board, deeply focusing on the field of Antibody Drug Conjugates (ADC).
On June 12th, Duality Biotherapeutics Inc (referred to as Duality Bio, stock code: 09606) has submitted its application for an IPO on the Shanghai Stock Exchange Sci-Tech Innovation Board.
On June 12th, Duality Biotherapeutics Inc (referred to as Duality Biotherapeutics) (09606) submitted its application for listing on the Shanghai Stock Exchange's Science and Technology Innovation Board (STAR Market). CITIC SEC is its sponsor institution, and it plans to raise 4.1 billion yuan.
According to the prospectus, Duality Biotherapeutics is a globally innovative biopharmaceutical company specializing in the field of antibody-drug conjugates (ADCs), dedicated to becoming a leader in the global ADC field. As of the signing date of the prospectus, the company has built a product matrix with a gradient of 10 clinical stage assets, conducting 10 global multi-center clinical trials in about 20 countries, with over 3,500 enrolled patients, about 50% of whom are from overseas. Among these, the BLA for the new drug indication for DB-1303 (HER2 ADC) in HER2+ breast cancer has been accepted by the National Medical Products Administration, and the global Phase III clinical trial enrollment for HER2 low-expressing breast cancer has been completed, placing the global progress in the leading position among similar HER2 ADCs. DB-1311(B7-H3 ADC) has entered the global Phase III clinical trial stage, making it the most advanced domestically produced B7-H3 ADC in the field of prostate cancer, and one of only two B7-H3 ADCs in the world to enter Phase III clinical trials.
In terms of external cooperation, Duality Biotherapeutics has reached several significant collaborations with global leading companies such as BioNTech, GSK, BeOne Medicines Ltd., 3SBIO, Avenzo, and Adcendo, with a total transaction value exceeding $6 billion, including upfront payments and milestone payments in stages, as well as ongoing revenue mechanisms such as franchise fee agreements. Duality Biotherapeutics also has cost and profit/loss sharing and joint promotion rights for DB-1311 in the United States.
Duality Biotherapeutics' products have shown breakthrough therapeutic potential in clinical trials, having received 1 FDA breakthrough therapy designation, 1 National Medical Products Administration breakthrough therapy designation, 5 FDA fast track designations, and 2 FDA orphan drug designations. Specifically, DB-1303 has received FDA breakthrough therapy designation, fast track designation, and National Medical Products Administration breakthrough therapy designation for uterine endometrial cancer with HER2 expression, making it the potential first global HER2 ADC drug to cover all levels of HER2 expression in uterine endometrial cancer (IHC 1+/2+/3+). DB-1311 has received FDA fast track designation for metastatic castration-resistant prostate cancer, platinum-resistant ovarian cancer, advanced cervical cancer, demonstrating potential clinical efficacy and manageable safety in several difficult-to-treat solid tumors, potentially becoming the first globally marketed B7-H3 ADC drug covering multiple cancer types. DB-1311 is also one of the few globally available drugs that can challenge first-line/back-line standard treatments comprehensively and directly compete with top B7-H3 ADCs.
As of the signing date of the prospectus, Duality Biotherapeutics has relied on four independently developed ADC technology platforms to build a structurally complete innovative drug pipeline for the global market, covering targets such as HER2, B7-H3, HER3, TROP2, BDCA2, B7-H3PD-L1, EGFRHER3, with multiple products in key tumor types and sub-indications ranking in the global first echelon of development, possessing similar first-in-class or best-in-class potential.
In terms of finances, the company is projected to achieve operating revenues of approximately 1.787 billion yuan, 1.941 billion yuan, and 1.852 billion yuan respectively for the years 2023, 2024, and 2025; during the same period, the proportion of research and development investment to operating revenue is expected to be 29.54%, 39.16%, and 44.81% respectively.
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