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[Photo: NMPA Approval of linperlisib]<\/i><\/p>\n
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\nYingli Pharma has entered into strategic partnership with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (\u201cHengrui Pharma<\/b>\u201d), a leading pharmaceutical company with well-established oncology sales and marketing network, to commercialize<\/span>\u56e0\u4ed6\u745e<\/span>\u00ae in China.![\"\"](\"https:\/\/eodishasamachar.com\/en\/wp-content\/uploads\/2022\/11\/Picture_12-300x157.png\")
<\/span><\/p>\nA safe and effective treatment choice for FL patients<\/b><\/span><\/p>\nLinperlisib is a next generation phosphoinositide 3-kinase delta (PI3K\u03b4) inhibitor independently developed by the Company. PI3K\u03b4 plays a key role in the tumor immune cell proliferation and survival, making it a potent target for non-Hodgkins lymphomas. Treatment options for R\/R FL patients, a major form of non-Hodgkins lymphoma, are extremely limited in China. In 2020, linperlisib was awarded NMPA Breakthrough Therapy status for the treatment of R\/R FL in China. In addition, it received U.S. Food and Drug Administration (FDA) Orphan Drug Designations for FL, Chronic lymphocytic leukemia\/ small lymphocytic lymphoma and T cell lymphoma.<\/span><\/p>\nIn the pivotal R\/R FL Phase II clinical trial in China, linperlisib-treated patients had an 79.8% overall response rate, a 96.6% disease control rate, a median Time to Response of 1.9 months, a median Progression Free Survival of 13.4 months, Duration of Response of 12.3 months and a 91.4% overall survival rate at 12 months1<\/sup>. Linperlisib was well-tolerated with a differentiated and manageable safety profile, with low immune-mediated toxicities. In the linperlisib-treated patient safety dataset of the pivotal study, the most common (>15%) non-hematologic treatment related adverse events (TRAE) (Any Grade\/ Grade<\/span>\u2265<\/span>3) were hypertriglyceridemia (25%\/3%), ALT elevation (19%\/2%), AST elevation (15%\/2%), diarrhea (15%\/2%), and pneumonia (15%\/15%). The most common (>5%) hematologic TRAEs (Grade<\/span>\u2265<\/span>3) were neutropenia (15%), leukocytopenia (5%), and lymphocytopenia (5%). <\/span><\/p>\n\u201cWe are pleased to provide a new treatment option for patients with R\/R FL with the approval of linperlisib. As linperlisib is the first innovative drug independently developed by Yingli Pharma, the NDA approval is a significant milestone\u201d, said
\nDr. Xu Zusheng, General Manager and President of R&D of Yingli Pharma<\/b>, \u201cWe would like to thank the patients, clinicians, and scientists for their generosity and great effort in the clinical development of linperlisib. It is a convenient once daily oral drug which demonstrated favorable safety, promising efficacy and great patient compliance. Yingli Pharma looks forward to in-depth collaboration with Hengrui Pharma to bring forth a full commercialization of <\/span>\u56e0\u4ed6\u745e<\/span>\u00ae and extend the clinical development into additional indications.\u201d<\/span><\/p>\nDr. Lianshan Zhang, Deputy General Manager and President of Global R&D of Hengrui Pharma<\/b><\/span>, said, ” We are delighted with the NDA approval of linperlisib (<\/span>\u56e0\u4ed6\u745e<\/span>) for R\/R FL. This approval is an important step for Hengrui Pharm to build a strong hematology franchise with an enriched pipeline. As Hengrui Pharma focuses on patient-centered R&D and innovation, we will continue to evaluate new indications for linperlisib, and combinations with the company’s existing products to potentially benefit more patients.\u201d<\/span><\/p>\n1. Lugui Qiu et al. 2022EHA.Abstract 1119<\/p>\n
Hashtag: <\/b>#YingliPharma<\/p>\n
The issuer is solely responsible for the content of this announcement.<\/em><\/p>\n<\/div>\n\n\n
Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"SHANGHAI, CHINA – Media OutReach – 9 November 2022 – Shanghai Yingli Pharmaceutical Co., Ltd. (the “Company” or “Yingli Pharma“) is pleased to announce that linperlisib, trade name\u56e0\u4ed6\u745e\u00ae, a novel phosphoinositide 3-kinase delta (PI3K\u03b4) inhibitor, has been approved by the National Medical Products Administration (NMPA) of China on November 9 for the treatment of relapsed\/refractory …<\/p>\n","protected":false},"author":1,"featured_media":27557,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[60],"tags":[],"_links":{"self":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/posts\/27556"}],"collection":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/comments?post=27556"}],"version-history":[{"count":1,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/posts\/27556\/revisions"}],"predecessor-version":[{"id":27565,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/posts\/27556\/revisions\/27565"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/media\/27557"}],"wp:attachment":[{"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/media?parent=27556"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/categories?post=27556"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/eodishasamachar.com\/en\/wp-json\/wp\/v2\/tags?post=27556"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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