The FDA's Advisory Committee on Oncology And Drugs voted on the application for a new drug incindilisumab and recommended that additional data need to be supplemented

SAN FRANCISCO, USA, Feb. 11, 2022 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) convenes the Advisory Committee on Oncology Drugs (ODAC) to discuss and vote on new drug applications (BAs) for sindilizumab. The BLA declared indications for the first-line treatment of non-squamous non-squamous non-small cell lung cancer (nsqNSCLC) are mainly based on the data of the ORION-11 clinical phase III trial in China. The committee voted on the need to supplement additional clinical trials prior to approval to demonstrate the suitability of sedilimab in U.S. populations and in U.S. medical practice. Sindili maclizumab is an innovative PD-1 inhibitor developed and commercialized by Cinda Biopharma Group ("Cinda Biotech", HKEx stock code: 01801) and Eli Lilly Pharmaceuticals (NYSE: LLY). Dr. Yongjun Liu, President of Cinda Biopharmaceutical Group "We are excited to have this opportunity to present DATAENT-11 to the FDA and the Committee of Experts," he said. ORIENT-11 is a high-quality, high-standard, experienced clinical investigator-involved Chinese clinical trial that meets the requirements of the globally certified GCP. Data from orient-11 trial results show that the combined benefits of sindilizumab outweigh the risks. The FDA does not have any doubts about the safety of sindilizumab. Although we regret the results of this ODAC vote, we will work with Eli Lilly to cooperate with THE FDA to continue to complete the review of the BLA application. We are as confident in the quality and value of Sindilizumab. This exchange with U.S. regulators will provide valuable experience in the development of Cinda's global pipeline, enabling Cinda to more smoothly bring innovative drugs to patients around the world. ” Jacob Van Naarden, president of Eli Lilly's oncology division, said

"While we regret the results of today's ODAC vote on sindilizumab, we are grateful for this opportunity to publicly and fully discuss the application for the registration of sindilizumab, as well as the extensive discussion on the regulatory scale for single-country clinical studies, and Eli Lilly and Innovent will work with the FDA to continue to complete the BLA-related review work." ”

The U.S. FDA Oncology Drug Advisory Committee (ODAC) provides FDA with independent professional advice on oncology drugs that have been listed and in the clinic FDA will adopt the ODAC voting opinion in the new drug approval process, but the ODAC voting opinion is not binding on FDA decisions Cinda Biologics and Eli Lilly Pharmaceuticals will continue to cooperate with FDA to complete the new drug review work.

concerning ORIENT-11 study

Secondary endpoints for progression-free survival (PFS), which were assessed by an independent imaging review committee based on the RECIST v1.1 criteria, included overall survival (OS), ORR, and safety.

A total of 397 participants enrolled in this study were randomized according to 2:1, received 200mg of sindilimab injection or placebo combined with pemetrexed and platinum, administered once every 3 weeks, and after completing 4 cycles of treatment, they entered the maintenance stage of sindilizumab or placebo combined with pemetrexed, and were treated until the disease progression. Findings of toxic intolerable or other conditions requiring discontinuation of treatment in the control group that can conditionally cross over to sindilizumab monotherapy ORIENT-11 after disease progression have been published in 2020.

About lung cancer Lung cancer is the leading cause of cancer deaths worldwide, with nearly 1.8 million people dying each year worldwide[i] In the United States, lung cancer is the second most common cancer (excluding skin cancer) and the leading cause of cancer deaths, accounting for nearly 25% of all cancer deaths – higher than colorectal, breast and prostate cancers combined[ii] Non-small cell lung cancer (NSCLC) accounts for about 85% of all lung cancers, and about 70% of NSCLC patients have non-squamous cell subtypes[iii]50% patients with NSCLC present with advanced or metastatic at the time of diagnosis[iv] About sindilliumab

Sindili maclizumab, Chinese trade name Daboshu ® (Sindili monoclonal antibody injection), is an innovative PD-1 inhibitor drug of international quality jointly developed by Innovent Biopharma and Eli Lilly Pharmaceuticals, which is a human immunoglobulin G4 (IgG4) monoclonal antibody that can specifically bind to the PD-1 molecule on the surface of T cells, thereby blocking the PD-1/programmed death receptor ligand 1 that leads to tumor immune tolerance. PD-L1) pathway, reactivating the antitumor activity of lymphocytes to achieve the purpose of treating tumors There are currently more than twenty clinical studies (more than 10 of which are registered clinical trials) currently underway to evaluate the antitumor effect of sindilizumab on various solid tumors and hematological tumors.

Sindilimab has been approved for four indications in China and successfully included in the Chinese National Health Insurance Catalogue, including:

• for the treatment of relapsed or refractory classical Hodgkin lymphoma with at least second-line systemic chemotherapy;
• Combination of pemetrexed and platinum chemotherapy for first-line treatment of EGFR or ALK-negative advanced non-squamous NSCLC;
• Combination of gemcitabine and platinum chemotherapy is indicated for first-line treatment of locally advanced or metastatic squamous NSCLC that cannot be surgically resected;
• Combination with bevacizumab is used in the first line of treatment for unresectable or metastatic hepatocellular carcinoma that has not previously received systemic therapy.

In addition, the marketing applications for three indications of sindilimab have been accepted and reviewed by the China Drug Administration (NMPA), including:

• Combination of cisplatin and paclitaxel / cisplatin and 5-fluorouracil for first-line treatment of advanced or metastatic esophageal squamous cell carcinoma;
• combination of oxaliplatin and capecitabine first-line treatment of unresectable locally advanced, recurrent or metastatic adenocarcinoma at the junction of the gastroesophageal and gastroesophageals;
• Combined with bevacizumab and chemotherapy for the treatment of EGFR-mutated non-squamous non-small cell lung cancer with an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI).

Two other clinical trials of sintilizumab met the endpoints, including:

• Phase II clinical study of monotherapy for second-line treatment of advanced/metastatic esophageal squamous cell carcinoma;
• Phase III clinical study of monotherapy for second-line treatment of advanced squamous non-small cell lung cancer with failed platinum-containing chemotherapy.

About Innovent Biologics

"Starting from the letter, reaching the line", developing high-quality biological drugs that the people can afford, is the ideal and goal of Cinda Biologics Founded in 2011, Cinda Bio is committed to developing, producing and selling innovative drugs for the treatment of major diseases such as tumors, metabolic diseases, autoimmunity On October 31, 2018, Cinda Biopharmaceuticals was listed on the main board of The Stock Exchange of Hong Kong Limited, stock code: 01801.

Since its inception, the company with innovative achievements and international operation mode in many biopharmaceutical companies stand out from the establishment of a product chain including 29 new drug species, covering tumors, metabolic diseases, autoimmunity and other disease areas, of which 7 varieties selected for the national "major new drug creation" special company has 6 products (Xindili monoclonal antibody injection, trade name: Daboshu ®, English trademark: TYVYT® bevacizumab biological analogue, trade name: Dayoutong ®, English trademark: BYVASDA® adalimumab biosimilar, trade name: Su Lixin ®, English trademark: SULINNO® rituximab biosimilar, trade name: dabowa ®, English trademark: HALPRYZApemigatinib®oral inhibitor, trade name: dabtan ®, English trademark: PEMAZYRE® orre batinib tablets, trade name: Nilik ®) approved for listing, 5 varieties into phase III or critical clinical research, An additional 18 products have entered clinical studies.

Innovent Biologics has set up a high-end biopharmaceutical development and industrialization talent team with international advanced level, including many returnee experts, and reached strategic cooperation with international partners such as Eli Lilly Pharmaceutical, Adimab, Incyte, MD Anderson Cancer Center and South Korea's Hanmi, hoping to work with everyone to improve the development level of China's biopharmaceutical industry. To meet the people's access to medication and the people's pursuit of good wishes for life and health, please visit the company's website: or the company LinkedIn account.

statement:

1. This indication is the drug usage in the study and has not been approved in the United States;

2. Cinda does not recommend any unapproved medicines/indications;

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[i] International Agency for Research on Cancer. 2018 Lung Cancer Fact Sheet. Available at: http://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Accessed January 18, 2022.

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[iv] Riess, J. Shifting Paradigms in Non-Small Cell Lung Cancer: An Evolving Therapeutic Landscape Supplement. Am J Manag Care. 2013;19:S390-S397.