After the approval of the seven major cancer types, China's domestically produced PD-1 monoclonal antibody is expected to benefit these cancer patients

The arrival of PD-1 inhibitors is undoubtedly a major breakthrough in the field of cancer treatment.

On February 19th, Junshi Biotech announced that Teriplimumab was approved by the National Medical Products Administration (NMPA) of China for the treatment of patients with relapsed/metastatic nasopharyngeal carcinoma who had previously failed second-line and above systemic treatments.

On February 3, Innovent announced that Sintilimab was officially approved by the NMPA for the first-line treatment of non-squamous non-small cell lung cancer in combination with pemetrexed and platinum-based chemotherapy.

On January 14, BeiGene announced that NMPA has approved tislelizumab combined with two chemotherapy regimens for the treatment of patients with first-line advanced squamous non-small cell lung cancer.

This article will combine public information to sort out the approved and upcoming indications for these approved anti-PD-1 antibodies? And which other companies' anti-PD-1 antibodies are expected to be approved this year?

Four approved anti-PD-1 antibodies have been submitted for 9 new indication applications

1.

Approved indications: melanoma, nasopharyngeal carcinoma

Teriprizumab was first approved in China at the end of 2018 for the treatment of locally advanced or metastatic melanoma after the failure of previous standard treatments.

At present, applications for two new indications of teriprizumab have been accepted: one is for teriprizumab for locally advanced or metastatic urothelial cancer that has failed or is intolerable in previous systemic treatments.

In February 2021, Junshi Biosciences has reached a cooperation with Coherus BioSciences to jointly develop and commercialize Teriplimumab in the United States and Canada.

2.

Approved indications: classic Hodgkin's lymphoma, non-small cell lung cancer (NSCLC)

Sintilizumab was jointly developed by Innovent and Eli Lilly and Company.

At present, Innovent is still carrying out more than 20 clinical studies (more than 10 of which are registered clinical trials) to evaluate the efficacy of Sintilimab in the treatment of various solid tumors and hematological cancers.

In August 2020, Cinda Bio and Eli Lilly announced that they would expand the strategic cooperation of Sintilimab Injection.

3.

Approved indications: Hodgkin's lymphoma, hepatocellular carcinoma, NSCLC, esophageal squamous cell carcinoma

Carrelizumab has been approved for four indications in China since it was approved for marketing in China in May 2019.

In addition to the aforementioned approved indications, Hengrui Medicine is also developing carrelizumab for the treatment of various cancers.

It is worth mentioning that in April 2020, Hengrui Medicine and Crystal Genomics of South Korea reached an agreement on carrelizumab.

4.
BeiGene: Tilelizumab

Approved indications: Hodgkin's lymphoma, urothelial carcinoma, NSCLC

Since its approval in December 2019, tislelizumab has been approved for three indications in China, namely: 1) Treatment of patients with relapsed or refractory classic Hodgkin’s lymphoma who have undergone at least second-line chemotherapy 2) The failure of platinum-containing chemotherapy for the treatment of PD-L1 high expression includes neoadjuvant or adjuvant chemotherapy for patients with locally advanced or metastatic urothelial cancer that has progressed within 12 months; 3) Combination of two chemotherapy regimens for the treatment of first-line advanced squamous cells Symptoms of NSCLC cancer patients.

In addition to the approved indications, BeiGene is conducting 15 registered clinical trials of tislelizumab in China and globally, including 13 phase 3 clinical trials and 2 key phase 2 clinical trials.
At present, NMPA has accepted the marketing application for two new indications of tislelizumab: one is combined chemotherapy for the treatment of first-line advanced non-squamous NSCLC patients; the other is for the treatment of previously treated unresectable NSCLC patients Patients with hepatocellular carcinoma.

It is worth mentioning that in January 2021, Novartis and BeiGene have just reached a cooperation with a total amount of over 2.
2 billion U.
S.
dollars to jointly develop and produce in North America, Japan, the European Union and 6 other European countries.
And commercialized tislelizumab.

Three anti-PD-1 monoclonal antibodies under development have been submitted for marketing applications

1.
Kangfang Biological / Chia Tai Tianqing: Paimrizumab

NDA indications: classic Hodgkin's lymphoma

Paimpulizumab (AK105) is a PD-1 monoclonal antibody drug, jointly developed and commercialized by a joint venture established by Kangfang Biotechnology and Chia Tai Tianqing, a subsidiary of China Biopharmaceuticals.
Public information shows that the product's Fc receptor and complement-mediated utility functions are completely removed by mutations in the Fc region, and it has the characteristics of a slower antigen binding and dissociation rate.
These features make Pianprizumab more effective in blocking the activity of the PD-1 pathway and maintaining stronger T cell anti-tumor activity, which may become an anti-PD-1 drug with better clinical benefits.

In May 2020, the new drug marketing application of Paimrizumab was accepted by NMPA for the treatment of patients with relapsed or refractory classic Hodgkin's lymphoma (r/r cHL) who have undergone at least second-line chemotherapy.
In addition, Paimrizumab also reached the primary endpoint in a registered clinical study for the third-line treatment of metastatic nasopharyngeal carcinoma.
In nasopharyngeal cancer patients who have undergone multi-line treatment in the past, the drug candidates have shown good clinical efficacy and safety.
In October 2020, the U.
S.
FDA granted fast-track qualification to Pianprizumab for the third-line treatment of metastatic nasopharyngeal carcinoma.

2.
Jiahe Bio: Genozumab

NDA indications: peripheral T-cell lymphoma

Genozumab (GB226) is a humanized IgG4 monoclonal antibody that targets immune cells PD-1 developed by Jiahe Biological.
According to reports, Genozumab can selectively block dual ligands (PD-L1 and PD-L2) to restore the ability of the immune system to recognize and kill cancer cells.
It is planned to be developed for the treatment of a variety of advanced solid tumors.

In July 2020, the new drug marketing application of Genozumab was accepted by NMPA for the treatment of peripheral T-cell lymphoma.
The application was subsequently included in the priority review by CDE.
According to Jiahe Biologics public information, Genozumab may become China's first PD-1 monoclonal antibody for the treatment of peripheral T-cell lymphoma.
At present, Jiahe Biosciences is carrying out a number of clinical trials on Genozumab in China, covering various indications such as peripheral T-cell lymphoma (PTCL), cervical cancer, and non-small cell lung cancer.

3.
Yuheng Bio: Sepalizumab

NDA indications: typical Hodgkin's lymphoma

According to a press release issued by Yuheng Pharmaceuticals earlier, Sepalizumab (GLS-010) is a fully human anti-PD-1 monoclonal antibody that has been naturally selected by the transgenic rat platform, which aims to further reduce this type of tumor The immunogenicity of immunotherapy drugs supports its wider and long-term clinical application.
It is worth mentioning that in August 2017, Yuheng Pharmaceutical has licensed the exclusive development and commercialization rights of the product in North America, Europe, Japan and other regions to Arcus Biosciences, which focuses on the research and development of innovative tumor immunotherapies.

In February 2020, the new drug application for sepalizumab injection was accepted by NMPA, and the proposed indication is: treatment of patients with relapsed or refractory classic Hodgkin's lymphoma above second-line.
It is worth mentioning that Sepalizumab was also selected for the first time in the 2020 edition of the "CSCO Lymphoma Diagnosis and Treatment Guidelines" in 2020, and was recommended by Level II experts.

Congratulations on the series of progress made by these domestic anti-PD-1 monoclonal antibodies, and look forward to them making more breakthroughs in follow-up studies and benefiting more patients as soon as possible.