Innovent Announces the Approval of Pemazyre® (pemigatinib) by the NMPA for the Treatment of Adults with Locally Advanced or Metastatic Cholangiocarcinoma with A FGFR2 Fusion or Rearrangement As Co...

SAN FRANCISCO and SUZHOU, China, April 6, 2022 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases announced that the National Medical Products Administration (NMPA) has approved Pemazyre^® (pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as confirmed by a validated diagnostic test that have progressed after at least one prior line of systemic therapy.

Pemazyre^®, discovered by Incyte and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan markets, is the first selective tyrosine kinase inhibitor approved for the treatment of cholangiocarcinoma, a type of biliary tract cancer, in China, representing a new milestone following its approval in Hong Kong market in January 2022, and in the Taiwan market in June 2021.

The approval in China was based on two clinical studies. One is the FIGHT-202 study, which is a Phase 2, multi-center, open-label, single-arm study (NCT02924376) evaluating the safety and efficacy of pemigatinib in adult (age ≥18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGFR2 fusion or rearrangement. The other study was a bridging study (CIBI375A201, NCT04256980) conducted in China evaluating the safety and efficacy of pemigatinib in Chinese cholangiocarcinoma patients. The primary end point was overall response rate (ORR) evaluated by an independent radiological review committee (IRRC) per RECIST V1.1.

In the FIGHT-202 study[1], as data cut of date (April 7^th,2020), a total of 108 subjects with FGFR2 fusion/rearrangement were enrolled and orally received pemigatinib 13.5mg per day（Q3W 2 weeks on/1 week off）, the IRRC-confirmed ORR was 37.0% (95% CI: 27.94%, 46.86%), including 4 complete responses(CR). The median duration of response (DOR) was 8.08 months with responses lasting ≥ 6 months in 26 of the 40 (66.0%) responding patients and ≥ 12 months in 15 (37.5%) patients. In study CIBI375A201, as of data cut-off date (January 29^th, 2021), among 30 efficacy evaluable Chinese subjects enrolled, the IRRC-confirmed ORR was 50%（95% CI: 31.3%,68.7%）. The overall safety profiles of FIGHT-202 and the study CIBI375A201 are similar and the majority of the adverse events were grade 1 or 2 per CTCAE V5.0. Pemigatinib was generally well tolerated in Chinese patients with cholangiocarcinoma.

Professor Jian Zhou in Zhong Shan Hospital Fudan University stated that: "Cholangiocarcinoma is the second most common malignancy originated in the liver with a high incidence rate in Asia. The disease is usually not diagnosed until it has already developed into an advanced unresectable and/or metastatic stage. There are limited treatment options currently, which call for innovative drugs."

"The approval of Pemazyre^® by the NMPA, following the approval in Hong Kong and Taiwan market earlier in Greater China market, represents that Innovent has further broadened our product market coverage. At the same time, the approval of Pemazyre^® also provided a new treatment option for cholangiocarcinoma patients in China." Dr. Yongjun Liu, President of Innovent, stated: "Data from previous clinical trials of Pemazyre^® in participants with advanced cholangiocarcinoma with FGFR2 fusion that have progressed after at least one prior line of systemic therapy has shown satisfactory safety results and also revealed encouraging efficacy signals. The approval further enhanced our confidence and interests in conducting in-depth clinical development of pemigatinib in more potential indications, including the ongoing global clinical trial (including China) evaluating pemigatinib as a first-line therapy for cholangiocarcinoma with FGFR2 fusion."

About Advanced Cholangiocarcinoma and FGFR2 Rearrangement

Cholangiocarcinoma is a malignant tumour originated from biliary epithelium cells and it is categorized as intrahepatic or extrahepatic based on anatomical location of origin. The incidence of cholangiocarcinoma has been increasing progressively over the past decade. Surgery is the first line treatment for patients with resectable disease. However, most cholangiocarcinomas have been in advanced and/or metastatic status at diagnosis and lost the chance for surgical resection. The treatment options for patients who relapse after surgery or have advanced / metastatic disease are limited and the recommended therapy method is systemic chemotherapy with gemcitabine plus cisplatin, which has a medium overall survival of less than a year.

Aberrant signaling through FGFR resulting from gene amplification or mutation, chromosomal translocation, and ligand-dependent activation of the receptors has been demonstrated in multiple types of human cancers. Fibroblast growth factor receptor signaling contributes to the development of malignancies by promoting tumor cell proliferation, survival, migration, and angiogenesis. Results from early clinical studies of selective FGFR inhibitors, including Pemazyre, have shown a tolerable safety profile for the class and preliminary signs of clinical benefit in participants with FGF/FGFR alterations.

About Pemazyre^® (pemigatinib)

In April 2020, the U.S. Food and Drug Administration (FDA) approved Incyte's Pemazyre^® (pemigatinib), a selective, oral inhibitor of FGFR isoforms 1, 2 and 3, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as detected by an FDA-approved test. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Japan, Pemazyre^® is approved for the treatment of patients with unresectable biliary tract cancer with a FGFR2 fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre^® is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Pemazyre^® is marketed by Incyte in the United States, Europe and Japan.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates discovered and developed by Incyte, including pemigatinib (FGFR1/2/3 inhibitor). Under the terms of the agreement, Innovent has received the rights to develop and commercialize the three assets in Mainland China, Hong Kong, Macau and Taiwan.

In March 2020, Innovent announced that the first patient was dosed in the pivotal registrational trial evaluating pemigatinib in patients with advanced cholangiocarcinoma in China.

In June 2021, Taiwan Food and Drug Administration (TFDA) approved Pemazyre^®  for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement.

In January 2022, Hong Kong Department of Health (DH) approved Pemazyre^®  for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

In April 2022, the National Medical Products Administration (NMPA) of China approved Pemazyre^® for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2（FGFR2） fusion or rearrangement as confirmed by a validated diagnostic test that have progressed after at least one prior line of systemic therapy.

Pemazyre^® is a trademark of Incyte Corporation.

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, metabolic 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 32 valuable assets in the fields of cancer, metabolic, autoimmune diseases and other major therapeutic areas, with 7 products, TYVYT^® (sintilimab injection), BYVASDA^® (bevacizumab biosimilar injection), SULINNO^® (adalimumab biosimilar injection), HALPRYZA^® (rituximab biosimilar injection), PEMAZYRE^® (pemigatinib), olverembatinib (BCR ABL inhibitor) and Cyramza^® (ramucirumab), 1 asset under NMPA NDA review, 5 assets in Phase 3 or pivotal clinical trials, and an additional 19 molecules 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, Adimab, Incyte, MD Anderson Cancer Center, Hanmi 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/.

Forward-Looking Statements

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