According to the official website of the Center for Drug Evaluation of the National Medical Products Administration, the marketing application of Huadao (Shanghai) Biopharmaceutical Co., Ltd. (hereinafter referred to as "Huadao Bio") for its first Class 1 new drug, Wanji Aolunsai Injection, has been accepted . This drug is used to treat refractory and relapsed non-Hodgkin lymphoma.

According to Insight database, Wanji Aolensai Injection was first applied for clinical trials in May 2018, and the first clinical trial results were announced five months later. This is the first marketing application for the drug.

Currently, several CAR-T products have been approved for marketing globally. According to publicly available information, the average international price of these marketed products exceeds US$400,000, while the average domestic price is approximately RMB 1.2 million. These prices significantly exceed the out-of-pocket payment capacity and the affordability of medical insurance reimbursement for Chinese patients.

Driven by the simple yet unwavering mission of "making cell therapy affordable for ordinary Chinese people," Yu Xuejun, founder of Huadao Bio, led his team through ten years of technological breakthroughs and submitted a marketing application for their first CAR-T cell therapy targeting refractory and relapsed non-Hodgkin's lymphoma to the Center for Drug Evaluation of the National Medical Products Administration at the end of last year. With the application accepted, a "Chinese solution" that benefits patients is rapidly moving from blueprint to reality.

It is reported that Huadao Bio is building a fully automated, enclosed, unmanned production base for personalized CAR-T cell drugs in Songjiang Economic Development Zone. The first phase of this base will have an annual production capacity of 9,000 doses per person, far exceeding the current domestic market's highest annual production capacity of less than 300 doses per person. In addition to Wanji Orenzai injection, Huadao Bio has four other CAR-T drugs targeting different cancer types that have entered Phase I-II clinical trials.

Huadao Bio was established in Shanghai in September 2017. Located in the Songjiang Economic and Technological Development Zone, a national-level development zone known as the "Songjiang Innovation Base," it is a biopharmaceutical company specializing in cell immunotherapy, with a particular focus on the entire industrial chain technology development and innovation of cell drugs.

It is worth noting that Huadao Bio completed its pre-IPO counseling registration with the Shanghai Securities Regulatory Bureau in March of this year, with Ping An Securities Co., Ltd. serving as the counseling institution.

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