Fosun Kite's CAR-T Therapy Nears Approval in China Amid Intensifying PD-1 Monoclonal Antibody Indication Race Involving BeiGene and Innovent

Highlights of the Week

1. China's First CAR-T Therapy Set for Imminent Market Approval!

2. Innovent Biologics’ PD-1 Monoclonal Antibody Gains Acceptance for Two New Indication Applications: First-Line Hepatocellular Carcinoma and Second-Line NSCLC!

3. BeiGene’s Tislelizumab Approved for Its First Lung Cancer Indication

4. China’s First! Luye Pharma’s Innovative Microsphere Formulation Approved in China for the Treatment of Schizophrenia

5. Luoxin Pharmaceutical’s Class 1 New Drug Tegoprazan Tablets Submitted for Marketing Approval

This Period (January 8 to January 15): CDE Accelerates Review and Approval; China’s First CAR-T Therapy Poised for Market Approval; Monoclonal Antibody Drugs Speed Up Expansion into New Indications; More Updates Below:

Domestic Review and Approval · New Developments

This week, the Center for Drug Evaluation (CDE) updated the manufacturing application status for 67 acceptance numbers (covering 41 drug varieties). Among these, Fosun Kite’s CAR-T therapy, Luye Pharma’s new long-acting risperidone microspheres for schizophrenia, and Beigene’s retifanlimab have attracted significant attention. Further developments are as follows:

China’s First CAR-T Therapy Set for Imminent Market Approval!

On January 11, the marketing application for Fosun Kite’s CD19 CAR-T therapy, yikicelene injection, was in the “under review” stage in China. It is expected to receive approval from the National Medical Products Administration (NMPA) in the near future, becoming the first CAR-T therapy marketed in China.

Yikiluncai Injection is a targeted CD19 autologous CAR-T cell therapy product, for which Fosun Kite Biotechnology Co., Ltd. has licensed the YESCARTA (Axicabtagene Ciloleucel) technology from Kite Pharma in the United States and obtained authorization for localized production in China. In October 2017, YESCARTA® was approved by the U.S. FDA for marketing in the United States, becoming the first CAR-T cell therapy approved by the FDA for specific types of non-Hodgkin lymphoma. In August 2018, YESCARTA® received marketing approval from the European Medicines Agency (EMA) for use in Europe. In February 2020, the National Medical Products Administration (NMPA) accepted the marketing application for Fosun Kite’s Yikiluncai Injection for the treatment of adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL transformed from follicular lymphoma. On March 5, 2020, the proposed marketing application for Yikiluncai Injection was included in the priority review program under Category I, Item 3, for drugs demonstrating significant therapeutic advantages.

As of now, there are 366 CAR-T therapies under development globally, with three CAR-T products approved for market launch: Kite Pharma’s Yescarta and Tecartus, and Novartis’ Kymriah, all targeting CD19. According to Yaozhi data, apart from Fosun Kite, only JW Therapeutics’ CAR-T product, rilocabtagene autoleucel, has submitted a marketing application in China. In addition, multiple CAR-T therapies are in clinical stages; notably, Legend Biotech’s BCMA-targeting CAR-T was included in the Center for Drug Evaluation’s (CDE) Breakthrough Therapy Designation program in August 2020. CAR-T therapy in China is rapidly advancing, with market entry imminent.

BeiGene’s Tislelizumab Approved for First Lung Cancer Indication

On January 13, BeiGene’s anti-PD-1 antibody Baizean (tislelizumab) received approval from the National Medical Products Administration for a new indication: in combination with two chemotherapy regimens for the first-line treatment of advanced squamous non-small cell lung cancer (NSCLC). This marks the first domestically produced PD-1 monoclonal antibody to gain approval for squamous NSCLC following pembrolizumab (Keytruda), and represents the third approved indication for Baizean in China, as well as its first indication in lung cancer.

Tislelizumab is the first candidate drug developed by BeiGene’s immuno-oncology biologics platform. It is a humanized IgG4 anti-PD-1 monoclonal antibody that was approved for marketing in China in December 2019 for the treatment of relapsed or refractory classical Hodgkin lymphoma. In April 2020, a second indication for tislelizumab—treatment of locally advanced or metastatic urothelial carcinoma—was approved. These two previously approved indications have been included in the 2020 National Reimbursement Drug List. Furthermore, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted and is currently reviewing two new marketing applications for Baizean (tislelizumab), including one for use in combination with chemotherapy as first-line treatment for patients with advanced non-squamous non-small cell lung cancer (NSCLC), and another for the treatment of patients with unresectable hepatocellular carcinoma who have received prior systemic therapy.

Tislelizumab is currently being developed as both monotherapy and combination therapy for a range of indications in solid tumors and hematologic malignancies, covering high-incidence cancers such as lung cancer, liver cancer, esophageal squamous cell carcinoma, and gastric cancer.

Source: Yaozhi China Clinical Trials Database

China’s First! Luye Pharma’s Innovative Microsphere Formulation Approved in China for the Treatment of Schizophrenia

On January 13, Luye Pharma’s Risperidone Microspheres for Injection (Ruixintuo) received approval for marketing from the National Medical Products Administration (NMPA) through its priority review pathway. It is indicated for the treatment of prominent positive and negative symptoms associated with acute and chronic schizophrenia and other psychotic states, and can alleviate affective symptoms related to schizophrenia. Ruixintuo® is a sustained-release microsphere formulation for injection, developed by Luye Pharma based on its globally leading novel long-acting formulation technology platform. It is the first independently developed, globally registered, innovative microsphere formulation with independent intellectual property rights in China.

Broshumab Approved for Marketing in China!

On January 14, Kyowa Hakko Kirin (China) Pharmaceutical Co., Ltd. officially received approval for three marketing applications for its new rare-disease drug, burosumab. Burosumab, discovered by the Japanese pharmaceutical company Kyowa Hakko Kirin, is an investigational recombinant fully humanized monoclonal IgG1 antibody targeting fibroblast growth factor 23 (FGF23). It was the first drug approved by the U.S. FDA for the treatment of X-linked hypophosphatemia (XLH) in children aged one year and older and in adults, and has been granted both Breakthrough Therapy Designation and Orphan Drug Status by the FDA. In China, the drug was included in the priority review program for rare disease treatments, indicated for FGF23-related hypophosphatemia, and was also listed among the second batch of urgently needed overseas new drugs for clinical use. Its recent approval for marketing in China is expected to improve therapeutic options for patients with XLH.

Domestic Review and Approval · Newly Accepted

This week, the CDE accepted 72 new marketing application submissions, covering a total of 52 drug varieties. Among them, Luoxin Pharmaceutical’s Class 1 innovative drug tegoprazan tablets and Innovent Biologics’ two monoclonal antibodies have drawn significant attention. For more updates, see the table below:

Luoxin Pharmaceutical Submits Marketing Application for Its Class 1 New Drug, Tegoprazan Tablets

Luoxin Pharmaceutical’s Tegoprazan Tablets are a potassium-competitive acid blocker (P-CAB). In December 2016, Shandong Luoxin submitted an Investigational New Drug (IND) application for Tegoprazan Tablets to the former China Food and Drug Administration (CFDA) under the Class 1 chemical drug registration category, and obtained clinical trial approval in June 2017. Currently, the marketing authorization application for Tegoprazan Tablets is under review.

Innovent Biologics’ PD-1 Monoclonal Antibody Receives Acceptance for Two New Indication Applications: First-Line Hepatocellular Carcinoma and Second-Line NSCLC!

On January 13, the Center for Drug Evaluation (CDE) successively accepted the new indication applications for Innovent Biologics’ sintilimab (Tyvyt) as second-line treatment for squamous non-small cell lung cancer (NSCLC), and for sintilimab in combination with bevacizumab biosimilar (Byvasda) as first-line treatment for patients with liver cancer.

Sintilimab is an innovative PD-1 monoclonal antibody co-developed by Innovent Biologics and Eli Lilly and Company. It was approved in China in late 2018 for the treatment of relapsed/refractory classical Hodgkin lymphoma. In November 2019, the drug was included in the National Reimbursement Drug List of China, becoming the first PD-1 inhibitor to be covered under this list. Furthermore, the National Medical Products Administration (NMPA) has successively accepted supplemental new indication applications for sintilimab as first-line therapy for both non-squamous and squamous non-small cell lung cancer (NSCLC).

The marketing application for the new indication of sintilimab in combination with bevacizumab for the first-line treatment of patients with hepatocellular carcinoma represents the fifth indication submission for sintilimab and the fourth indication submission for Byvasda. Previously, bevacizumab had received approval from the National Medical Products Administration (NMPA) for three indications, including advanced non-small cell lung cancer (NSCLC), metastatic colorectal cancer, and recurrent glioblastoma in adults. The new indication application for sintilimab as second-line treatment for squamous NSCLC is the third new indication submission for this product in the field of non-small cell lung cancer.

Data Source: Publicly available online data from Yaozhi Data, corporate announcements, etc.

Source: Publicly available online information from YAOZHI.com, corporate announcements, etc.

Responsible Editor: Liu Li

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