​Enter "Under Approval"!

Recent popular reports by Yimike ★ The article elaborates: CAR-T production whole-process solution combing ★ Focusing on CAR-T cell transformation, where is the next generation of CAR-T therapy? Medicine New Observation May 31, 2021/eMedClub News/--China's National Medical Products Administration (NMPA) drug registration progress query results show that Cinda Bio and Eli Lilly and Company collaborated on research and development For the PD-1 inhibitor Sintilimab, the review status of its new indication for marketing application has been updated to: Under approval, which means that this new indication is expected to be approved in the near future.

According to Cinda Bio's earlier press release, this is the third indication submitted by Sintilimab in China for the first-line treatment of squamous non-small cell lung cancer (NSCLC).

▲ Image source: NMPA official website Sintilimab is an innovative PD-1 inhibitor drug jointly developed by Innovent and Eli Lilly.
It can specifically bind to PD-1 molecules on the surface of T cells, thereby blocking the cause The PD-1/PD-L1 pathway of tumor immune tolerance reactivates the anti-tumor activity of lymphocytes, so as to achieve the purpose of treating tumors.

In August 2020, Eli Lilly and Cinda Biosciences expanded their cooperation and obtained the exclusive license of Sintilimab outside of China.

In China, Sintilimab has been approved for two indications: for the treatment of relapsed or refractory classic Hodgkin’s lymphoma that has undergone at least second-line systemic chemotherapy, and combined with pemetrexed and platinum-based chemotherapy First-line treatment of advanced non-squamous NSCLC with EGFR or ALK negative.

Just a week ago, Sintilimab also submitted a new drug marketing application to the FDA.
The indication is: combined with pemetrexed and platinum for the first-line treatment of non-squamous NSCLC.

According to the press release issued by Cinda Biologics, the entry of Sintilimab into the "under review" new indication marketing application is mainly based on a randomized, double-blind, phase 3 controlled clinical trial called ORIENT-12 Research result.

This study aims to evaluate the effectiveness and safety of sintilimab or placebo combined with gemcitabine and platinum in the first-line treatment of advanced or metastatic squamous NSCLC.

A total of 357 subjects were enrolled in the study, randomly enrolled according to 1:1, and received Sintilizumab injection 200mg or placebo combined with gemcitabine and platinum therapy, once every 3 weeks, completing 4-6 After one cycle of treatment, enter Sintilimab or placebo for maintenance treatment until the disease progresses, toxicity is intolerable, or other conditions that require termination of treatment.

The control group can conditionally cross to Sintilizumab injection monotherapy after disease progression.

According to the data released by Innovent at the 2020 European Society of Medical Oncology (ESMO) annual meeting, the results of the interim analysis showed that the combination therapy of Sintilimab significantly prolonged the progression-free survival (PFS).

Specifically, the median PFS evaluated by the Independent Imaging Committee (IRRC) in the Sintilimab combination group and the chemotherapy group were 5.
5 months and 4.
9 months, respectively, and the median PFS evaluated by the investigator were 6.
7 months and 4.
9 months, respectively.
Month, reached the preset main research endpoint.

The median OS data for the interim analysis is not yet mature, and the sintilimab combination group has a trend of benefit in overall survival compared with the chemotherapy group.

The safety characteristics are consistent with previously reported research results of Sintilimab, and there is no new safety signal.

Public information shows that the incidence and mortality of lung cancer are very high, of which NSCLC accounts for about 80% to 85%.

About 70% of NSCLC patients cannot be surgically removed at the time of diagnosis, and 30-60% of patients with stage I-III NSCLC undergoing radical surgery will eventually recur or have distant metastases.

In the past two decades, the development of NSCLC drugs has mainly focused on non-squamous NSCLC.
Due to its unique epidemiological, histopathological and molecular biological characteristics, drug development has been relatively slow for squamous NSCLC.

Innovent has stated in a press release that patients with squamous NSCLC still have large unmet medical needs.
The ORIENT-12 study confirmed that the combination of PD-1 antibody and gemcitabine and platinum can significantly improve first-line squamous The progression-free survival benefit of NSCLC patients has important clinical significance.

It is hoped that the new indication of Sintilimab will be approved as soon as possible, bringing more treatment options to patients with squamous NSCLC.

Article source: 1.
Pharmaceutical Guanlan "Entering "Under Approval", Cinda Bio-PD-1 Inhibitor is expected to usher in the third indication in China" Yimike has always been committed to the cutting-edge technology, industry trends, and industry insights of bio-innovative drugs According to original news reports, all-media high-end matrix users reached 160,000+, among which industrial users accounted for more than 50%, scientific research and clinical users accounted for about 30%, and investment institutions accounted for more than 5%.

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