Huadao Biologics IPO: Building a Domestic Full-Chain Ecosystem to Break the High-Price Barrier of CAR-T Therapy

On April 30, the Center for Drug Evaluation under the National Medical Products Administration announced that the marketing application of HuaDao CAR-Tcell's first Class 1 new drug—Wanjiaolun Race Injection, a CAR-T cell therapy for refractory and relapsed non-Hodgkin lymphoma—has been officially accepted for the treatment of refractory and relapsed non-Hodgkin lymphoma. On April 2, the website of the China Securities Regulatory Commission showed that HuaDao CAR-Tcell had submitted a tutoring filing report to the Shanghai Regulatory Bureau for its initial public offering and listing.

How dare a company whose drug hasn't even been marketed yet rush for an IPO? Moreover, it signaled that "the pricing after going public will be only over 200,000 yuan, aiming to break the price range of domestically marketed CAR-T products, which are all between 999,000 and 1.29 million yuan."

In response to the questions from the Health Client of the People's Daily, Yu Xuejun, Chairman and General Manager of HuaDao CAR-Tcell, introduced that in 2015, at the beginning of the company's establishment, the founding team decided to initiate independent innovation of core technologies across the entire industry chain while advancing drug research and development. The aim was to break the import monopoly from the source and pave the way for "affordable pricing."

Yu Xuejun told the reporter: "As a breakthrough tumor treatment technology of the 21st century, CAR-T therapy is moving from the laboratory to clinical applications. However, nearly all core equipment, consumables, and reagents in the global industry are monopolized by European and American companies. In the field of cell therapy, the root cause of high costs lies in the 'complete reliance on imported supply chains.' A set of imported GMP cell production equipment costs more than 2.5 million yuan and can only produce 25 to 30 batches per year. Imported disposable consumables cost over 100,000 yuan per unit, and viral vector costs range from 15,000 to 30,000 US dollars. These cumulative costs make it difficult for CAR-T drugs to be priced below one million yuan."

After repeated efforts, on June 27, 2023, the全产业链 production technology of HuaDao CAR-Tcell passed the associated technical review by the Center for Drug Evaluation of China. From this moment on, Yu Xuejun believed that he had led his team to fully打通 (thoroughly establish) every link from底层技术 (basic technology) to最终产品 (final product), establishing a fully proprietary,全流程全自动全封闭 (full-process, fully automatic, fully enclosed) cell production technology. Additionally, they developed corresponding reagents, consumables, and pharmaceutical packaging materials.

"This means that we have fully mastered the entire set of production technology in our own hands," said Yu Xuejun. "As everyone knows, cell drugs themselves are an entirely new category of medicine, and the industrial technology is even more unprecedented. We are also the first company in China to submit a full industry chain technology change before the confirmatory clinical trial—everything is new."

In the new factory of HuaDao CAR-Tcell, reporters saw the "Ant Workshop" independently developed by HuaDao. Yu Xuejun introduced: "This set of unmanned production, fully automatic and fully enclosed cell drug intelligent manufacturing equipment completely replaces imported core equipment. Not only is the cell production technology more advanced, but the manufacturing cost is also only about one-tenth of imported products. This system can increase production capacity to more than 50 times that of traditional methods, while also raising the success rate of cell production from around 80% traditionally to 99%, further reducing the unit manufacturing cost. Currently, the designed annual production capacity of the phase II production base under construction can reach 9,000 person-doses, far exceeding the maximum annual capacity of less than 300 person-doses for domestically marketed products in China."

To design this system, Yu Xuejun spent every day in the laboratory and workshop, personally overseeing every step—from the blueprint design of core equipment to the formula adjustment of reagent materials, from optimizing production processes to establishing quality control standards.

Therefore, when HuaDao CAR-Tcell's entire industry technology change application was approved, the excitement and emotion felt by all HuaDao employees were indescribable. "We have now completed the confirmatory clinical trial, held a communication meeting with the CDE regarding the drug marketing application, and have officially submitted the marketing authorization application."

"Although the specific clinical trial data cannot be disclosed for now, what can be revealed is that the CAR-T cells produced by HuaDao CAR-Tcell with fully independent industrial technology can be compared head-to-head for superiority in terms of both safety and efficacy data against related cellular drug products already on the market, both in China and internationally. This indirectly proves the advanced nature and reliability of our fully independent industrial technology." Yu Xuejun appeared to be highly confident about this.

He also revealed that currently, apart from the first HD CD19 CAR-T for refractory and relapsed non-Hodgkin lymphoma, which is in the marketing application stage, HuaDao CAR-Tcell has four other CAR-T drugs targeting different types of cancers that have entered Phase I-II clinical trials. These include two CAR-T cell therapies for solid tumors aimed at reducing postoperative metastasis and recurrence in the future. The pricing of the first drug will serve as the basis for the pricing of subsequent products.

By the end of 2025, HuaDao CAR-Tcell will launch the layout of five major industrial bases across China, covering the five regions of East, North, South, Southwest, and Northwest China, enabling patients to receive standardized CAR-T treatment close to home. This addresses the pain points of cold chain transportation and strong time sensitivity for cell-based drugs.

Whether this全产业链自主创新 approach, regarded by many in the biopharmaceutical industry as far-fetched, will ultimately succeed in bringing cell therapy drugs—once considered "astronomically expensive luxuries"—into an affordable price range for ordinary people is a result worth watching.

Original Title: HuaDao CAR-Tcell IPO: Establishing a Localized Full Industry Chain to Break the High-Cost Barrier of CAR-T