China's First CD19-Targeted CAR-T Therapy Enters Clinic as New Player WuXi JuNova Submits IPO Prospectus

New Developments in Domestic CAR-T Research: Following Legend Biotech, JW Therapeutics Becomes the Second Company to Gain Approval for Clinical Trials of Its CAR-T Therapy

Yesterday, JW Therapeutics (Shanghai) Co., Ltd. and its affiliate, Shanghai Mingju Biotechnology Co., Ltd., announced that the National Medical Products Administration (NMPA) had approved the clinical trial application for Mingju Biotechnology’s CAR-T product, JWCAR029. Developed independently by JW Therapeutics based on Juno Therapeutics’ JCAR017 in the United States, this approval marks JWCAR029 as the first CD19-targeted CAR-T product to receive clinical trial authorization since the former China Food and Drug Administration (CFDA) issued the “Technical Guidelines for Research and Evaluation of Cell Therapy Products (Trial)” in December 2017.

01

The CAR-T Application Frenzy

Currently, there have been 23 CAR-T therapy applications filed in China, including 19 targeting CD19. These 19 applications came from 14 companies, among which Nanjing Legend Biotech’s LCAR-B38M successfully secured the first domestic CAR-T clinical trial approval on March 13 this year. This also caused its parent company, GenScript, to see its stock price rise by nearly 10% on that day.

In addition, other companies in China filing for CAR-T therapy approvals include Fosun Kite, Chengdu Galaxy Biopharmaceuticals, Shanghai Hengrun Dasheng Biotechnology, CARsgen Therapeutics, BoSheng JiAnKe Cell Technology, Shanghai Mingju Biotechnology, Shanghai Ucarti Biotechnology, and Beijing ImmuneOnco Biopharmaceuticals. These companies are primarily focused on hematologic malignancies, such as leukemia and lymphoma. CARsgen Therapeutics’ investigational product targets hepatocellular carcinoma, representing an application in solid tumors. It is anticipated that domestically produced CAR-T products will be sequentially launched in the market over the next 3–5 years.

Currently, three companies—Galaxy Biopharma, CARsgen Therapeutics, and Hengrun Dasheng—have completed technical reviews in pharmacology, toxicology, and pharmaceutical sciences, and are expected to receive clinical trial approval in the near future. Meanwhile, Fosun Kite has localized technology and production by introducing Yescarta, a CAR-T therapy already marketed abroad, positioning it to potentially become the first company to launch a CAR-T therapy in China.

Internationally, since 2012, CAR-T therapy has repeatedly demonstrated remarkable efficacy, with more than 25 research centers worldwide confirming its effectiveness in treating diseases such as leukemia and lymphoma. In 2017, the U.S. FDA approved the marketing of CAR-T products Kymriah and Yescarta.

CAR-T research has now entered a highly competitive phase, with Novartis, Kite Pharma, and Juno Therapeutics emerging as the three industry leaders, boasting substantial expertise in product development, clinical research, and academic promotion. Currently, multiple companies worldwide have advanced their projects to the clinical stage, and it is anticipated that CAR-T products targeting various tumors will be successively launched in the future.

Some research teams believe that the CAR-T industry is poised for a "golden decade." Global sales of CAR-T therapies for hematologic malignancies are projected to reach $27.8 billion by 2027, with China's CAR-T market for these indications expected to attain RMB 10 billion. Furthermore, given that CAR-T represents the future direction of cancer immunotherapy, if safety profiles can be further improved while maintaining remission rates, CAR-T therapies are well-positioned to capture a larger share of the hematologic malignancy market, potentially exceeding $100 billion.

02

Behind JW Therapeutics

On March 8, 2018, JW Therapeutics announced the completion of its $90 million Series A financing round.This round of investment was led by Temasek, Sequoia Capital China, and Yuanming Capital. Other investors included existing shareholders such as WuXi AppTec Group and Juno Therapeutics (U.S.).

JW Therapeutics was established in Shanghai in 2016 as a joint venture between WuXi AppTec and Juno Therapeutics. Under the agreement, WuXi AppTec and Juno Therapeutics hold equal equity stakes in the newly formed JW Therapeutics. Upon achieving development milestones, JW Therapeutics has the option to select products from Juno’s pipeline for development and commercialization in China; in return, Juno Therapeutics will receive corresponding upfront payments or equivalent equity, milestone payments, and sales royalties. Li Ge, founder of WuXi AppTec, serves as Chairman of JW Therapeutics. James Li (Li Yiping), co-founder of JW Therapeutics and former General Manager of Amgen China, has been appointed as Chief Executive Officer of JW Therapeutics.

WuXi AppTec’s partnership with Juno Therapeutics was not its first foray into the field of immune cell therapy. As early as March 2015, WuXi AppTec announced the construction of a new CAR-T cell and related cancer immune cell therapy manufacturing facility in the United States, dedicated to the production of relevant equipment, and stated that the new plant would commence operations in mid-2016. Therefore, the approval by the National Medical Products Administration (NMPA) of the Investigational New Drug (IND) application for JW Therapeutics’ CAR-T product is expected to generate significant revenue for WuXi AppTec and bolster its confidence in further expanding its presence in the immune cell therapy sector.

Juno was one of the “big three” pioneers in CAR-T research in the United States. During the Phase II clinical trial of its CAR-T therapy JCAR015, two patient deaths occurred, leading Juno to halt the trial and subsequently shift its focus to JCAR017. Nevertheless, Juno did not falter. In December 2017, Juno released updated clinical data demonstrating that JCAR017 exhibited remarkable efficacy in treating relapsed or refractory B-cell non-Hodgkin lymphoma. The company anticipated filing an application with the U.S. Food and Drug Administration (FDA) that year, with approval for market launch expected by year-end. In January 2018, Juno was acquired by Celgene for $9 billion.

Furthermore, the “Technical Guidelines for Research and Evaluation of Cell Therapy Products (Trial),” issued by the former China Food and Drug Administration (CFDA) in December 2017, also stated that the release of CAR-T products could refer to foreign marketed products, thereby paving the way for the accelerated market approval of CAR-T products in China.

Source: E-Pharma Manager

(Translational Medicine Network 360zhyx.com)