Innovent Announces the Second Breakthrough Therapy Designation by NMPA for Olverembatinib for the Treatment of Patients with SDH-Deficient GIST

ROCKVILLE,Md. and SUZHOU,China,June 3,2023 -- 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,ophthalmologyand other major diseases,announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for olverembatinib for the treatment of patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) who had received first-line treatment.

Results from an ongoing Phase 1b/2 study of olverembatinib in China showed an impressive clinical benefit rate (CBR) of 93.8% in patients with this subtype of GIST. Based on these promising results,the study was selected for presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting for two consecutive years[1].

Olverembatinib is the first and only third-generation BCR-ABL inhibitor approved in China for the treatment of adult patients with tyrosine kinase inhibitors (TKI)-resistant chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation as confirmed by a validated diagnostic test. Olverembatinib is jointly commercialized in China by Ascentage Pharma and Innovent Biologics.

This marks the second BTD granted to olverembatinib by the CDE,with the first one granted in March 2021 for the treatment of patients with CML-CP resistant and/or intolerant to first- and second-generation TKIs. A New Drug Application (NDA) for the first BTD indication was accepted by the NMPA in July 2022 and subsequently granted Priority Review designation that will support a full approval of olverembatinib.

Dr. Hui Zhou,Senior Vice President of Innoventstated:" We are glad to see the NMPA grants another BTD for olverembatinib,marking a major milestone in its clinical development and demonstrating its therapeutic potentials beyond hematologic malignancies. We look forward to more good news of olverembatinib that allow more patients to benefit from this novel drug as soon as possible."

NMPA Breakthrough Therapy Designation is intended to facilitate and expedite the development and review of an investigational drug to treat a serious disease or condition when preliminary clinical evidence indicates that the drug has demonstrated substantial improvement over current therapies. The BTD will not only qualify a drug candidate to receive status for rapid review by the CDE,but it will also allow the sponsor to obtain timely advice and communication from the CDE to accelerate the approval and launch to address the unmet clinical need of patients at an accelerated pace. Click here for the published list of drugs which have been granted BTD by NMPA.

About Gastrointestinal Stromal Tumor (GIST)

GIST is a type of malignancy that arises in mesenchymal tissues of the gastrointestinal tract,and most patients with GIST harbor KIT or PDGFRA mutations. The introduction of TKIs has significantly improved the prognosis of these patients. However,patients with SHD-deficient GIST,a rare subtype of GIST,still have considerable unmet medical needs. It is known to the research community that patients with SDH-deficient GIST are commonly insensitive to existing TKIs. Although patients with early-stage localized disease can benefit from surgical treatment,most of them eventually experience relapse[2]-[6]. At present,there is no standard of care for patients with relapsed or advanced SDH-deficient GIST,whose 5-year event-free survival (EFS) is only 24%[2]-[6].

About Olverembatinib

Developed by Ascentage Pharma with support from the National Major New Drug Discovery and Manufacturing Program in China,the orally active,third-generation BCR-ABL inhibitor olverembatinib is the first China-approved third-generation BCR-ABL inhibitor targeting drug-resistant chronic myeloid leukemia (CML). Olverembatinib can effectively target a spectrum of BCR-ABL mutants,including the T315I mutation.

In November 2021,olverembatinib was granted a conditional approval through the Priority Review process by the China National Medical Products Administration (NMPA) for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic-phase CML (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation as confirmed by a validated diagnostic test. Subsequently,Olverembatinib was included into the China 2022 National Reimbursement Drug List (NRDL) for the approved indication. In March 2021,olverembatinib was granted a Breakthrough Therapy Designation (BTD) by the CDE for the treatment of patients with CML-CP who are resistant and/or intolerant of first- and second-generation TKIs.

In overseas,olverembatinib was cleared by the US FDA in July 2019 to directly enter a Phase Ib study. Since 2018,the clinical results of olverembatinib have been selected for oral presentations at the American Society of Hematology (ASH) Annual Meetings for five consecutive years,and was nominated for "Best of ASH" in 2019. To date,olverembatinib has been granted one Fast Track Designation (FTD) and four Orphan Drug Designations (ODDs) from the US Food and Drug Administration (FDA) for the treatment of CML,acute lymphoblastic leukemia (ALL),acute myeloid leukemia (AML),and gastrointestinal stromal tumour (GIST); and one Orphan Designation from the European Medicines Agency (EMA) of the European Union for the treatment of CML.

In July 2021,Ascentage Pharma (6855.HK) and Innovent Biologics (1801.HK) reached the agreement regarding the joint development and commercialization of olverembatinib in China.

*Olverembatinib has not been approved for any indication in the U.S.

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 in the fields of oncology,metabolism,autoimmunity,ophthalmology 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 35 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,6 assets are in Phase 3 or pivotal clinical trials,and 18 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/.

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

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.

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.

Innovent,the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

Reference

[1]. Qiu H,Zhou Z,Zhou Y,et al. Antitumor activity of olverembatinib (HQP1351) in patients (pts) with tyrosine kinase inhibitor (TKI)–resistant succinate dehydrogenase (SDH)–deficient gastrointestinal stromal tumor (GIST). J Clin Oncol 41,2023 (suppl 16; abstr 11540).

[2]. Mantese G. Gastrointestinal stromal tumor: epidemiology,diagnosis,and treatment. Curr Opin Gastroenterol. 2019; 35(6): 555-559.

[3]. Call JW,Wang Y,Rothschild S,et al. Treatment responses in SDH-deficient GIST. LRG Science,https://liferaftgroup.org/2019/08/treatmentresponses-in-sdh-deficient-gist.

[4]. Nannini M,Rizzo A,Indio V,et al. Targeted therapy in SDH-deficient GIST. Ther Adv Med Oncol. 2021; 13: 17588359211023278.

[5]. Weldon CB,Madenci AL,Boikos SA,et al. Surgical Management of Wild-Type Gastrointestinal Stromal Tumors: A Report From the National Institutes of Health Pediatric and Wildtype GIST Clinic. J Clin Oncol. 2017; 35(5): 523-528.

[6]. Mullassery D,Weldon CB. Pediatric/"Wildtype" gastrointestinal stromal tumors. Semin Pediatr Surg. 2016; 25(5): 305-310.