Keji Pharmaceutical (02171. HK) has made new progress in its universal CAR-T products. On February 10th, Keji Pharmaceutical announced that the first enrolled patient of the universal BCMA CAR-T developed based on the THANK-u Plus platform had a strict sense of complete response (sCR) and minimal residual disease (MRD) negative efficacy evaluation at the 28th day visit.

According to its introduction, the patient is a recurrent/refractory multiple myeloma IgA - λ type (R-ISS stage II), who has received first-line combination therapy and autologous hematopoietic stem cell transplantation in the past. After the last treatment, the disease progressed and was included in the clinical trial. This CAR-T product is intended for the treatment of relapsed/refractory multiple myeloma (R/R MM) or relapsed/refractory plasma cell leukemia (R/R PCL).

Affected by this news, on February 10th, the stock price of Keji Pharmaceutical rose by more than 12% at one point after opening, and finally closed at HKD 9.66 per share, up 3.43%.

Li Zonghai, founder, chairman of the board, and CEO of Keji Pharmaceutical, emphasized to Time Finance that for companies developing universal CAR-T, solving core technological challenges is the key. Pharmaceutical companies not only need to run fast, but also need to run far, with the ultimate goal of meeting the needs of patients

The cost of universal CAR-T is expected to decrease by 90%

As a leading enterprise in the domestic CAR-T field, Keji Pharmaceutical has made layouts in both autologous CAR-T and generic CAR-T fields. At present, the company has a total of 10 CAR-T pipeline products. Among them, the all human BCMA autologous CAR-T cell product, Zewawo Orense Injection (trade name: Saikai Ze), has been approved for market in China; Claudin18.2 autologous humanized CAR-T product, Shuruiqiolonsai injection (CT041), announced preliminary positive results of a key phase II clinical trial in China by the end of 2024, and is expected to become the world's first solid tumor CAR-T product to submit a new drug application for market launch. In the field of universal CAR-T, the highly anticipated CT0590 has entered phase I clinical trials, in addition to KJ-C2320 for the treatment of acute myeloid leukemia and KJ-C2114 for the treatment of solid tumors.

Due to the personalized customization feature, the production cost of autologous CAR-T is high, and it has been dubbed as a "sky high price anti-cancer drug" since its launch. At present, the six CAR-T products that have been launched in China are all autologous CAR-T products, with prices generally around one million yuan. In contrast, the universal CAR-T uses T cells provided by healthy volunteers, which can be prepared in batches in advance. This not only significantly reduces production costs, but also significantly shortens patient waiting time.

Li Zonghai told Time Finance that currently, the production cycle of autologous CAR-T and universal CAR-T is basically the same, but universal CAR-T can be prepared in bulk in advance. From the current production scale of the industry, obtaining cells from a healthy donor can lead to the preparation of 100 doses of CAR-T therapy in a single dose, so the per capita cost is expected to be reduced by more than 90% compared to autologous CAR-T.

The biggest challenge faced by universal CAR-T has always been host anti graft response (HvGR), which can lead to insufficient persistence of therapeutic efficacy. Due to the use of allogeneic T cells in universal CAR-T, treatment may cause the patient's T cells and NK cells to attack allogeneic CAR-T cells, leading to rejection reactions and affecting the efficacy.

In early November 2024, the CT0590 Phase I clinical trial data released by Keji Pharmaceutical at the ASH (American Society of Hematology) annual meeting attracted industry attention, with particularly noteworthy data on persistence. The experimental data showed that a total of 5 subjects were enrolled in CT0590 Phase I for the first time, with a median follow-up time of 16.6 months. Three subjects achieved objective remission, one achieved unconfirmed objective remission (unable to be re evaluated in a timely manner due to Covid-19), and two of them achieved strict complete remission (sCR). Among the two subjects who achieved sCR, one patient with relapsed and refractory multiple myeloma (RRMM) had a duration of efficacy (DoR) exceeding 23 months as of the data deadline (still in continuous remission and having reached a remission duration equivalent to autologous BCMA CAR-T), and one patient with relapsed and refractory primary plasma cell leukemia (pPCL) had a DoR of 20 months. Its therapeutic effect on PCL far exceeds the previously reported efficacy of autologous BCMA CAR-T on PCL (the duration of efficacy in patients treated with autologous BCMA CAR-T for PCL in previous reports was less than 10 months).

Regarding this, Li Zonghai told Time Finance that the core reason for the poor effectiveness of previous universal CAR-T products is that they have not completely solved the problem of host anti graft reactions, resulting in limited efficacy of the products after being injected into patients' bodies. The reason why the Phase I data of CT0590 has attracted attention is also because both patients who achieved complete remission achieved sustained remission for 20 months or more, which has not been reported in previous general CAR-T studies.

Li Zonghai specifically pointed out that there is currently a lack of standard treatment plans for plasma cell leukemia, and the previously reported autologous BCMA CAR-T therapy for plasma cell leukemia has a duration of efficacy of less than 10 months for patients. Although there are currently few cases, the performance of CT0590 shows that the efficacy of universal CAR-T in the treatment of multiple myeloma and plasma cell leukemia may not be inferior to, or even surpass, autologous CAR-T in terms of persistence.

When will it be commercialized?

In addition to Keji Pharmaceutical, in the past year, pharmaceutical companies including Bangyao Biotechnology and Chengdu Youseno Biotechnology have successively announced new developments in their generic CAR-T products. In October 2024, Bangyao Biotechnology announced that its new generation of universal CAR-T (BRL-303) successfully treated autoimmune diseases. Three patients with rheumatic immune diseases achieved long-term remission after use, and the related results also made headlines on the official website of Nature.

In January 2025, Chengdu Youseno Biotechnology announced that its independently developed universal CAR-T (UC101) targeting CD19 had been approved by the US Food and Drug Administration (FDA) for new drug clinical trial application (IND) on January 11, becoming the first universal CAR-T product in China to pass the FDA's new drug clinical trial application.

Regarding when the market can wait for the official commercialization of the universal CAR-T, Li Zonghai told Time Finance that, taking Keji Pharmaceutical as an example, the company's goal is to submit an IND this year. If the progress goes smoothly, it is expected to be approved for listing 3-4 years after launching IND clinical trials.

On the other hand, Time Finance has noticed that since September 2024, the stock price of Keji Pharmaceutical has continued to rise. In less than six months, the company's stock price has cumulatively increased by 197%. This performance not only far exceeds the overall trend of the pharmaceutical sector during the same period, but also stands out in the field of biomedicine.

When it comes to the rise in the company's stock price, Li Zonghai believes that it is only a natural occurrence. He pointed out that the field of immune cell therapy is a big blue ocean in the pharmaceutical industry, but unfortunately, the CAR-T products currently on the market are all autologous, and the indications are only for blood tumors, with a small audience. Once a company successfully solves the key challenges of allogeneic CAR-T technology and solid tumors, it will be more widely applied in tumors, autoimmune diseases, etc. The market will naturally give the company the value it deserves. Otherwise, no matter how good the stock price rises, it will only be a flash in the pan.