Innovent Announces the National Medical Products Administration in China Has Accepted and Granted Priority Review Designation to the New Drug Application for Parsaclisib (PI3Kδ inhibitor) for the Treatment of Relapsed or Refractory Follicular Lymphoma

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Jan 05, 2023, 23:22 ET

ROCKVILLE, Md. and SUZHOU, China, Jan. 5, 2023 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that the New Drug Application (NDA) for parsaclisib (PI3Kδ inhibitor, R&D code: IBI376) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two previous systemic therapies has been accepted for review by China's Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) and granted Priority Review designation^[1].

The acceptance and Priority Review designation for this NDA are based on the results from a multi-center, single-arm, open-label pivotal Phase II study conducted in China (NCT04298879), most recently presented at the 2022 American Society of Clinical Oncology (ASCO) meeting.

As of the December 12, 2021 data cut-off date, the objective response rate (ORR) seen with parsaclisib monotherapy was 86.9% (53/61, 95%CI: 75.8%, 94.2%) in FL patients who had received at least two previous systemic treatments (n=61), 19 patients (31.1%) had a complete response (CR) and 34 patients (55.7%) achieved a partial response (PR). The median duration of response (DOR) and median progression-free survival (PFS) were not yet achieved, and the majority of patients continued to be in remission. Among the 61 patients treated with parsaclisib, twenty-seven patients (44.3%) experienced grade ≥ 3 treatment emergent adverse events (TEAEs), and the most common grade ≥ 3 TEAEs was a decrease in neutrophil count (n=10, 16.4%). The results also showed that parsaclisib was generally well tolerated with a manageable safety profile.

Dr. Weili Zhao of Shanghai Jiaotong University Ruijin Hospital, commented: "FL is the second most prevalent type of non-Hodgkin's lymphoma (NHL), accounting for about one-fifth of NHL patients, and is the most common indolent NHL. Although most patients with FL respond to first-line therapy, relapse is common and it is difficult to cure with current therapies, placing a significant burden of disease on patients. We look forward to seeing more patients with relapsed or refractory FL benefit once approved."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "Treatment options for relapsed or refractory FL remain limited and there is a huge unmet clinical need. The NDA for parsaclisib in China was accepted and granted Priority Review designation, which is a milestone for the clinical research for parsaclisib, and if approved, will expand Innovent's pipeline with one more innovative product in the field of hematology. We will actively cooperate with regulatory authorities and hope to obtain early approval of this indication, which could lead to more treatment options for patients with relapsed or refractory follicular lymphoma."

About Follicular Lymphoma

According to GLOBOCAN 2020 estimates, there were approximately 93,000 new cases of non-Hodgkin lymphoma (NHL) in China. Follicular lymphoma (FL) is the second most common NHL, accounting for 22% - 35% of NHL patients in Western countries and 8.1% - 23.5% of NHL patients in China. FL is a B-cell cancer that originates from the uncontrolled division of specific types of B-cells known as centrocytes and centroblasts. Although it is classified as an indolent lymphoma, where current immunochemotherapy is efficacious, FL may still relapse and transform into an aggressive lymphoma, which may lead to death within 1 to 2 years. There is an unmet medical need for treatment options for recurrent/refractory follicular lymphoma.

About Parsaclisib

Parsaclisib is a highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ) discovered by Incyte. Pivotal trials of parsaclisib in combination with ruxolitinib for the treatment of patients with myelofibrosis are underway.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates, including parsaclisib (PI3Kδ inhibitor). Under the terms of the collaboration agreement, Innovent has received the rights to develop and commercialize parsaclisib in Mainland China, Hong Kong, Macau and Taiwan.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune disease, metabolic disorder and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 36 valuable assets in the fields of cancer, metabolic disorder, autoimmune disease and other major therapeutic areas, with 8 approved products on the market. These include: TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) , Pemazyre® (pemigatinib oral inhibitor), olverembatinib (BCR-ABL TKI) , Cyramza® (ramucirumab) and Retsevmo® (selpercatinib). An additional 3 assets are under NMPA NDA review, 5 assets are in Phase 3 or pivotal clinical trials, and 20 more molecules are in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com. and www.linkedin.com/company/innovent-biologics/.

Note:

TYVYT® (sintilimab injection) is not an approved product in the United States.

BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States.

TYVYT® (sintilimab injection, Innovent)

BYVASDA® (bevacizumab biosimilar injection, Innovent)

HALPRYZA® (rituximab biosimilar injection, Innovent)

SULINNO® (adalimumab biosimilar injection, Innovent)

Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

CYRAMZA® (ramucirumab, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Retsevmo® (selpercatinib, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Disclaimer: Innovent does not recommend any off-label usage.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

^[1] Priority Review Designation accelerates the research and development of innovative drugs that have significant clinical advantages and fills urgent medical needs. According to the Provisions for Drug Registration (SAMR Order No. 27) and Working Procedures for Priority Review and Approval of Drug Marketing Authorization (Interim) (No. 82 of 2020) implemented on July 1, and July 7, 2020, respectively, the regulatory authority will prioritize the review process and evaluation resources for NDAs which helps accelerate the market access of these innovative drugs. Priority review designation is not an approval for marketing the drug.

SOURCE Innovent Biologics