① Keji Pharmaceutical has been in a state of loss since its launch. Compared with 2022, the loss margin was relatively narrow in 2023. ② At the end of last year, the company's stock price was hit hard twice in a short period of time. ③ In March of this year, the company's first CAR-T product, Sikaize, was approved for sale. Keji Pharmaceutical expects the peak annual terminal sales of this product to reach more than 1 billion yuan.
Financial Services Association, March 26 (Reporter He Fan) According to the 2023 report released today, Keji Pharmaceutical-B (02171.HK) has been in a loss since its launch, but compared with 2022, its losses narrowed last year by 144 million yuan to 748 million yuan.
The company attributed this to three points. First, the reduction in share-based remuneration, the second was the reduction in R&D and administrative expenses, and the third was the reduction in exchange losses. Since listing on the Hong Kong Stock Exchange in 2021, the company has been losing money for three consecutive years. Furthermore, the company's cash and bank balances were reduced to $1.85 billion, a year-on-year decrease of $418 million.
According to the annual report, the company's current research pipeline mainly focuses on CAR-T products, involving various indications such as multiple myeloma, gastric cancer, and solid tumors. In addition, it also includes a mAb product, which is indicated for gastric cancer and pancreatic cancer.
2023 was not calm for Keji Pharmaceutical. The November FDA study found that CAR-T cell immunotherapy targeting BCMA or CD19 had a serious risk of causing T-cell malignancies, or was affected by this fundamentals. Keji Pharmaceutical fell more than 23% on November 29. The next day, the company issued a statement on its public account, saying, “Currently, CAR-T products are being developed, and the total number of patients treated in clinical trials exceeds 500. Of these, BCMA CAR-T products target more than 250 cases, and no cases of T-cell tumors have been observed. We believe that this incident had no real impact on the development and commercialization process of the company's products.”
Immediately after that, on the evening of December 12, the company announced that its US subsidiary had received a notice from the FDA requesting that clinical trials of three CAR-T cell therapy products be suspended. The pipeline that has been suspended includes the company's core candidate product, Zevorkiolense injection (R&D code: CT053). Affected by this news, Keji Pharmaceutical-B once fell more than 30% on the 13th, and its stock price hit a record low.
Regarding the incident, the annual report shows that the company submitted a response and a corrective and preventive action (CAPAs) plan with a schedule to the FDA on December 28, 2023.
In March of this year, the company finally ushered in good commercialization news. On March 1, the company announced that the State Drug Administration had officially approved the new drug marketing application for the treatment of adult patients with recurrent or refractory multiple myeloma, which progressed after at least 3 lines of treatment (using at least one proteasome inhibitor and immunomodulator). CT053
The launch of Zewocki Orense injection is of great significance to Keji Pharmaceutical. It has changed the situation where the company has not yet launched a product.
Keji Pharmaceutical told the Financial Federation reporter that the initial price of the company's CAR-T therapy Saikaiser was 1.15 million. In terms of revenue, Saikaiser's annual terminal sales are expected to peak at more than 1 billion yuan.
However, since CAR-T therapy is a highly personalized immune cell treatment, it is very expensive, and the price of one dose, which can easily cost millions of yuan in the Chinese market, is often discouraging.
In response, Keji Pharmaceutical told the Financial Federation reporter that the company will actively help patients receive support such as Huimin Insurance and commercial insurance. It hopes to improve the accessibility of CAR-T treatment with more diversified payment methods in the future. At the same time, it will follow national health insurance policy developments with Huadong Pharmaceutical to participate in and seek relevant policy support while comprehensively considering factors such as cost and patient accessibility.
In terms of manufacturing, the company stated in its annual report that the proprietary platform it developed took about 30 hours to manufacture CAR-T cells, and currently three production plants are in operation.
Furthermore, on January 16, 2023, Huadong Pharmaceutical (000963.SZ) and Keji Pharmaceutical announced that they have reached a commercial cooperation in mainland China for the Zewokie Orense injection. According to the terms of the agreement, Huadong Pharmaceutical will pay a down payment of 200 million yuan, as well as registration and sales milestone payments of up to RMB 1,025 million. Keji Pharmaceutical will continue to be responsible for the development, registration and production of CT053 in mainland China. According to the annual report, Koji Pharmaceutical received the first commercialization milestone payment of RMB 75 million on the date of this announcement.
In August 2023, Koji Pharmaceuticals and Medner launched a cooperation agreement to study the combined effects of CT041 and Medner's experimental Claudin18.2 mRNA cancer vaccine. CT041 is another CAR-T product of the company. It is used to treat Claudin 18.2 positive solid tumors, mainly gastric cancer, esophagastric junction adenocarcinoma, and pancreatic cancer.