SHANGHAI,Nov. 14,2024 -- Mabwell (688062.SH),an innovative biopharmaceutical company with entire industry chain,announced that its novel Nectin-4 targeting ADC (R&D code: 9MW2821) has received IND approval for two clinical studies. The first will explore its use in combination with a PD-1 monoclonal antibody in the treatment of perioperativeurothelial carcinoma,while the second will investigate its combination with other antitumor agents for the treatment of advanced solid tumors.

The recent approval of a multi-drug combination treatment program for cervical cancer and esophageal squamous cell carcinoma,along with the expansion of 9MW2821's indication to include the perioperative stage for urothelial carcinoma,is anticipated to significantly broaden the therapeutic reach of 9MW2821,potentially benefiting a larger patient population.

9MW2821 is a novel Nectin-4 targeting ADC developed by Mabwell. It stands out as the first clinical-stage drug candidate among Chinese companies for this specific target. Clinical studies for 9MW2821 are underway across a range of tumor indications:

Urothelial Carcinoma (UC):

Monotherapy has advanced to Phase III clinical trials and is included in the CDE's Breakthrough Therapy Designation (BTD) list.

Combinationtherapy with PD-1 has entered Phase III clinical trials.

Combinationtherapy with PD-1 for perioperative UC has been approved for clinical research.

Cervical Cancer (CC):

The first drug candidate targeting Nectin-4 to enter Phase III clinical trials globally.

Combinationtherapy with PD-1 and other drugs has been approved for clinical research.

Received FDA Fast Track Designation (FTD).

Triple-Negative Breast Cancer (TNBC):

Monotherapy (post-chemotherapy and topoisomerase ADC treatment) has entered Phase II clinical trials.

Combinationtherapy with PD-1 has entered Phase II clinical trials.

Received FDA FTD.

Esophageal Cancer (EC):

Monotherapy has entered Phase II clinical trials.

Combinationtherapy with PD-1 and other drugs has been approved for clinical research.

Received FDA FTD for esophageal squamous cell carcinoma (ESCC); received FDA Orphan Drug Designation (ODD).

About Mabwell

Mabwell (688062.SH) is an innovation-driven biopharmaceutical company with the entire value chain of the pharmaceutical industry. We provide more effective and accessible therapy and innovative medicines to fulfill global medical needs. Since 2017,an advanced R&D system which covers target discovery,early discovery,druggability,preclinical,clinical research and manufacturing transformation was established. Mabwell has 15 pipeline products in different stages based on a world-class and state-of-the-art R&D engine,including 11 novel drug candidates and 4 biosimilars. We focus on the therapeutic areas of oncology,immunology,bone disorders,ophthalmology,hematology and infectious diseases,etc. Of these,3 products have been approved and commercialized,1 product has been filed for MA,3 products are in pivotal trials. We have also undertaken 1 national major scientific and technological special project for "Significant New Drugs Development",2 projects for National Key R&D Programmes,and multiple provincial and municipal science and technological innovation projects. Mabwell's Taizhou factory possesses robust in-house manufacturing capability compliant with international GMP standards regulated by the NMPA,FDA and EMA,and has passed the EU QP Audit. The large-scale manufacturing base in Shanghai and the ADC commercialized manufacturing base in Taizhou are under construction. Our mission is "Explore Life,Benefit Health" and our vision is "Innovation,from ideas to reality". For more information,please visit www.mabwell.com/en.

Forward-Looking Statements

This press release contains forward-looking statements including,but not limited to,the potential safety,efficacy,regulatory review or approval and commercial success of our product candidates and those relating to the Company's product development,clinical studies,clinical and regulatory milestones and timelines,market opportunity,competitive position,possible or assumed future results of operations,business strategies,potential growth opportunities and other statements that are predictive in nature. "Forward-looking statements" are statements that are not historical facts and involve a number of risks and uncertainties,which may cause actual results to be materially different from any future results expressed or implied in the forward-looking statements. These statements may be identified by the use of forward-looking expressions,including,"expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would," and similar expressions and the negatives of those terms.

Forward-looking statements are based on the Company's current expectations and assumptions. Forward-looking statements are subject to a number of risks,uncertainties,and other factors,many of which are beyond the Company's control,but not limited to: environment; politic; economy; society; legislation; our dependence on our product candidates,most of which are still in preclinical or various stages of clinical development; our reliance on third-party vendors,such as contract research organizations and contract manufacturing organizations; the uncertainties inherent in clinical testing; our ability to complete required clinical trials for our product candidates and obtain approval from regulatory authorities for our product candidates; our ability to protect our intellectual property; the potential impact of COVID-19; the loss of any executive officers or key personnel. In case one or more of these risks or uncertainties deteriorate,or any assumptions are incorrect,the actual results may be seriously inconsistent with the stated results.

The Company cautions all the persons not to place undue reliance on any such forward-looking statements,which speaks only as of the date of this press release. The Company disclaims any obligation,except as specifically required by law and the rules of the applicable Stock authority to publicly update or revise any such statements to reflect any change in expectations or in events,conditions,or circumstances on which any such statements may be based,or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. All forward-looking descriptions,figures and assumptions in this press release are applicable to this statement.