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Based on China to Go International: The Trastuzumab Biosimilar HLX02 Applied for Marketing

may 14, 2019 By 1℃

According to the announcement of Henlius on Apr. 25, 2019, the marketing application of the trastuzumab HLX02 has been accepted by NMPA, with the acceptance No. of CXSS1900021 and the indications applied for being early-stage HER2+ breast cancer, metastatic breast cancer, and metastatic gastric cancer. HLX02 is one of the 4 core products of Henlius and is being conducted a global Phase 3 clinical trial in China, Poland, Ukraine, and the Philippines. The marketing of the drug in China will mark a milestone of the product’s development and commercialization. Roche’s trastuzumab has so far been marketed for 21 years in the world and 17 years in China, with global sales reaching CHF6.982 billion and sales in China reaching about RMB2.7 billion in 2018. The marketing of HLX02 in China will benefit more cancer patients to effectively reduce patients’ medical payment pressure!

Based on China to Go International: The Trastuzumab Biosimilar HLX02 Applied for Marketing

This article describes the development process of HLX02 and summarizes the key development nodes of the drug according to the data disclosed by Henlius.

1. HLX02: trastuzumab from China to the world

As one of the 4 core products (HLX01, 02, 03, 04) of Henlius, trastuzumab HLX02 project was commenced in May 2011 and has taken 8 years so far. HLX02 has become the first biosimilar developed in China and conducted Phase 3 clinical trial in many regions in the world (China and the Philippines in Asia, and Poland and Ukraine in Europe). And Henlius has entered into cooperation agreements for commercialization of the drug with Accord, Cipla, and Jacobson, to further accelerate the internationalization process of the drug.

Development progress of Phase 1 and Phase 3 clinical trials of HLX02:

Trial registration No.

Title

Trial phase

Status

CTR20150642

Phase I clinical study of the safety and tolerance of different doses of HLX02 and PK comparison between HLX02 and Herceptin

Phase 1

Completed

CTR20160526

Phase III trial to compare the safety and effectiveness of HLX02 and Herceptin in treating breast cancer

Phase 3

Underway (recruitment completed)

Data reference: Drug Clinical Trial Registration and Information Publicity Platform of CDE

According to the information queried, HLX02 has two registered clinical trials, separately CTR20150642 and CTR20160526, wherein:

CTR20150642

Professional title: A Phase I clinical trial to evaluate the safety and tolerance of different doses of HLX02 and the pharmacokinetic characteristics, safety, tolerance, and immunogenicity of HLX02 and Herceptin

Enrolled patients: 123

The first patient enrolled on: Sep. 22, 2015

Completed on: May 11, 2016

Design of the trial as follows:

The Phase 1 clinical trial is divided into two parts, i.e., part 1 is open, dose arising trial, with 12 Chinese healthy males to accept 2, 4, 6 and 8 mg/kg single-dose HLX02. According to the data, HLX02’s pharmacokinetics showed a positive correlation with the dose, and different doses of the drug all showed good tolerance.

Part 2 of the trial is a multicenter, randomized, and double-blind study, with 111 patients grouped according to 1:1:1 to separately receive 6 mg/kg HLX02, Herceptin sold in China, and Herceptin sold in the EU. According to the data, AUC0-inf (90% CI) geometric mean was separately 0.914, 0.950, and 0.962 in patients using HLX02, Herceptin sold in China, and Herceptin sold in the EU; the 90% CIs of the means were bounded within the predefined bioequivalence criterion of 80% to 125%.

Drug safety: Good

In part 1 of the trial, 8 adverse reactions were reported and all were treatment emergent adverse event (TEAE), including 7 ADRs, commonly: glutamic-pyruvic transaminase elevation, drowsiness, and dizziness, without SAE, withdrawal from treatment, or death;

In part 2 of the trial, the safety results of the 3 groups had comparability, without statistical differences, and without adverse event above CTCAE grade III, death, or serious adverse event (SAE) detected.

The immunogenicity was good. Among the 3 treated group in part 2, the ADA detection results were all negative.

1. CTR20160526: A multicenter clinical trial that is underway

Professional title: A Phase 3 clinical trial to compare the efficacy, safety, and immunogenicity in untreated HER2+ metastatic breast cancer treated with HLX02 and Herceptin

The first patient was enrolled for CTR20160526 on Nov. 11, 2016, and the patient recruitment was completed in June 2018. The trial is still underway. The clinical trial is supported by China’s National S&T Major Project for Major New Drug Invention during the 13th Five-year Plan period and among the S&T Supported Projects in the Biomedical Field of the Science and Technology Innovation Action Plan, with the project No.: 2018ZX09736016; 16431901300.

The indication of the Phase 3 clinical trial is untreated HER2+ metastatic breast cancer, and the indication in the marketing application is extended to early-stage HER2+ breast cancer and HER+ metastatic gastric cancer. The clinical trial results have not been published, which sustained attention can be paid to.

2. Important development nodes of trastuzumab HLX02

Date

Event

May 2011

HLX02 project was commenced

Apr. 2013

An IND was filed for HLX02, with the indication of breast cancer

CXSL1200099

July 2014

An IND was filed for HLX02, with the indication of gastric cancer

CXSL1400065

July 2015

CXSL1200099 was approved for the clinical trial

Jan. 2016

CXSL1400065 was approved for the clinical trial

Sep. 2015

CTR20150642

The first patient was enrolled for the Phase 1 clinical trial

May 2016

CTR20150642

The Phase 1 clinical trial was completed

Nov. 2016

CTR20160526

The first patient was enrolled for the Phase 3 clinical trial

June 2017

The IND of HLX02 was approved

Ukraine

Sep. 2017

The IND of HLX02 was approved

Poland

Oct. 2017

The IND of HLX02 was approved

Philippines

Dec. 2017

Henlius entered into a cooperation agreement with Jacobson

Jacobson obtains the development and commercialization rights and benefits in Hong Kong and Macao and the right of first negotiation in some ASEAN countries

June 2018

CTR20160526

The recruitment for the Phase 3 clinical trial was completed

June 2018

Henlius entered into a license agreement with Accord

Accord obtains the commercialization license in 53 countries in Europe including the UK and France, 17 countries in the Middle East and North Africa including Saudi Arabia and the United Arab Emirates, etc., and some CIS countries

June 2018

Henlius entered into a license agreement with Cipla

Cipla obtains the exclusive license and commercialization rights in Australia, New Zealand, Colombia, and Malaysia

Sep. 2018

Data of Phase 1 clinical trial of HLX02 were released

2018

HLX02 received the support by China’s National S&T Major Project

Apr. 25, 2019

HLX02 was applied for marketing

Related:

Super-blockbuster: Trastuzumab

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