HSINCHU, Taiwan and WUHAN, China, July 9, 2018 /PRNewswire/ -- JHL Biotech has announced it received a positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the EU approval pathway for its proposed rituximab biosimilar, JHL1101.
The EMA, like other regulatory authorities such as the U.S. Food and Drug Administration and State Drug Administration of China (SDA), adopts the principle of a step-wise approach and the totality of the evidence from all studies in regulating the development and approval of biosimilars. In its correspondence to JHL, the EMA confirmed it agrees with JHL's development approach, clinical development proposal, and study design of the global Phase III clinical study for JHL1101 in patients with diffuse large B-cell lymphoma. Based on the EMA's review of these factors, the results of the Phase III clinical study will be acceptable for the submission of a Marketing Authorization Application as a biosimilar product, assuming the Phase III trial is completed successfully. Provided the proposed studies provide sufficient evidence, an extrapolation for all approved indications of MabThera (a brand name of rituximab) can be considered.
JHL has also recently received a Clinical Trial Permit (CTP) from the Center for Drug Evaluation (CDE) of the SDA for a global Phase III clinical study of JHL1101 in patients with diffuse large B-cell lymphoma. Therefore, a global Phase III study of JHL1101 can be initiated in China, Europe, and other countries in the following months.
About JHL Biotech
JHL Biotech, Inc. is a biopharmaceutical company founded by a group of industry veterans with deep experience in biologics development and operations. With a mission to provide the world with affordable medicines of exceptional quality, the company is focused on research and development of new protein-based therapies and biosimilars. JHL Biotech's experienced leadership team, ongoing global clinical trials for its pipeline of biosimilar candidates and two Asia-based world-class biologics manufacturing facilities built in accordance with United States, European Union, and ICH cGMP regulations and standards uniquely position the company to be a leading global supplier of high quality biologics. JHL Biotech is backed by premier financial firms, including Kleiner Perkins Caufield & Byers, Sequoia Capital, Biomark Capital, Milestone Capital, Fidelity and the China Development Industrial Bank. For more information, please visit www.jhlbiotech.com.
Media Contact:Ellis Chu: [email protected] phone: +886 3-658-3899Jill Liu: [email protected] phone: +886 3-658-3899Amber Chen: [email protected] phone: +886 3-658-3899
Forward-Looking Statement
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. JHL undertakes no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond the control of either company. Actual results or outcomes may differ materially from those implied by the forward-looking statements.
Advertisement
The EMA, like other regulatory authorities such as the U.S. Food and Drug Administration and State Drug Administration of China (SDA), adopts the principle of a step-wise approach and the totality of the evidence from all studies in regulating the development and approval of biosimilars. In its correspondence to JHL, the EMA confirmed it agrees with JHL's development approach, clinical development proposal, and study design of the global Phase III clinical study for JHL1101 in patients with diffuse large B-cell lymphoma. Based on the EMA's review of these factors, the results of the Phase III clinical study will be acceptable for the submission of a Marketing Authorization Application as a biosimilar product, assuming the Phase III trial is completed successfully. Provided the proposed studies provide sufficient evidence, an extrapolation for all approved indications of MabThera (a brand name of rituximab) can be considered.
Advertisement
JHL has also recently received a Clinical Trial Permit (CTP) from the Center for Drug Evaluation (CDE) of the SDA for a global Phase III clinical study of JHL1101 in patients with diffuse large B-cell lymphoma. Therefore, a global Phase III study of JHL1101 can be initiated in China, Europe, and other countries in the following months.
About JHL Biotech
JHL Biotech, Inc. is a biopharmaceutical company founded by a group of industry veterans with deep experience in biologics development and operations. With a mission to provide the world with affordable medicines of exceptional quality, the company is focused on research and development of new protein-based therapies and biosimilars. JHL Biotech's experienced leadership team, ongoing global clinical trials for its pipeline of biosimilar candidates and two Asia-based world-class biologics manufacturing facilities built in accordance with United States, European Union, and ICH cGMP regulations and standards uniquely position the company to be a leading global supplier of high quality biologics. JHL Biotech is backed by premier financial firms, including Kleiner Perkins Caufield & Byers, Sequoia Capital, Biomark Capital, Milestone Capital, Fidelity and the China Development Industrial Bank. For more information, please visit www.jhlbiotech.com.
Media Contact:Ellis Chu: [email protected] phone: +886 3-658-3899Jill Liu: [email protected] phone: +886 3-658-3899Amber Chen: [email protected] phone: +886 3-658-3899
Forward-Looking Statement
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. JHL undertakes no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond the control of either company. Actual results or outcomes may differ materially from those implied by the forward-looking statements.
