Fosun Henlius' Trastuzumab Biosimilar Receives FDA Approval; Hansoh Pharma In-Licenses QX004N Anti-IL-12/23 mAb from QuanX Biotech; Domestic PDE4 Inhibitor Momelotinib Submitted for Marketing Approval

Apr 26, 2024 19:17 CST Updated 19:17

Henlius

Innovative Biopharmaceutical Company

Hansoh Pharma

Pharmaceutical Research, Production, and Sales

Qyuns

Developer of Biologics for Autoimmune and Allergic Diseases

Next Milestone! Shanghai Henlius Biotech, Inc.'s Trastuzumab Approved by FDA for Market Launch

On April 26, the U.S. FDA approved the listing of Shanghai Henlius Biotech, Inc.'s trastuzumab biosimilar (U.S. trade name: Hercessi, China trade name: Hansel) for the adjuvant treatment of HER2-overexpressing early breast cancer, HER2-overexpressing metastatic breast cancer, and HER2-overexpressing metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.

Trastuzumab (Herceptin), originally developed by Roche, is an anti-HER2 monoclonal antibody and currently a cornerstone drug for the treatment of HER2-positive breast cancer. It was first approved by the FDA in 1998.Since its launch, Herceptin has achieved cumulative sales of up to 97.396 billion Swiss francs, with peak annual sales reaching 7.014 billion Swiss francs. However, after its patent expiration, multiple biosimilars have been successively approved for marketing, causing its sales to decline year by year.

Hanquyou is the first China-developed monoclonal antibody drug to receive dual approval from both Europe and China. It was successively approved for marketing by the European Commission in July 2020 and by the National Medical Products Administration (NMPA) of China in August 2020, covering all indications approved for the original drug.

Shanghai Henlius Biotech, Inc. conducted a series of head-to-head comparative studies on Hanquyou, including quality comparison studies, preclinical studies, Phase I clinical studies, and international multicenter Phase III clinical studies. These data fully demonstrate that Hanquyou is highly similar to the original trastuzumab in terms of quality, safety, and efficacy.

In 2021, Shanghai Henlius Biotech, Inc. signed a licensing agreement with Accord US, granting it exclusive rights to develop and commercialize the product in the United States and Canada.

In terms of business performance, Hanquyou has also achieved remarkable sales results since its launch. According to the 2023 financial report of Shanghai Henlius Biotech, Inc., the annual sales revenue of Hanquyou reached 2.737 billion yuan, including nearly 100 million yuan from overseas markets, representing a year-on-year increase of 162.3%. With the continued penetration of the global market, its sales are expected to grow further in the future.

Hansoh Pharma Acquires an Autoimmune Monoclonal Antibody from Quanxin Biotech in an Over 11 Billion Yuan Deal

Recently, Hansoh Pharma announced that it has entered into a licensing agreement with Quanxin Biotech to obtain the rights to develop and commercialize the QX004N monoclonal antibody in China (including Hong Kong, Macao, and Taiwan).

According to the agreement, Hansoh Pharma will be responsible for the research and development, production, and commercialization of all developable dosage forms and indications of QX004N in China. They will pay an upfront payment of 75 million RMB and potential milestone payments of up to 1.032 billion RMB based on research and development, regulatory progress, and sales-based commercial achievements, as well as tiered royalties based on future product sales.

It is reported that QX004N is an innovative candidate drug applicable for psoriasis and Crohn's disease. As of the date of this announcement, multiple clinical studies of QX004N have been initiated, and its current highest stage of development in China is Phase II clinical trials.

Hansoh Pharma's key therapeutic areas cover oncology, anti-infectives, central nervous system, metabolism, and autoimmune diseases. In 2023, its revenue from the oncology sector was approximately RMB 6.169 billion, accounting for 61.0% of total revenue; revenue from the anti-infectives sector was about RMB 1.269 billion, accounting for 12.6% of total revenue; total revenue from the central nervous system sector was approximately RMB 1.367 billion, accounting for 13.5% of total revenue; revenue from the metabolism and other sectors was about RMB 1.299 billion, accounting for 12.9% of total revenue.

A PDE4 Inhibitor Produced in China Submitted for Market Approval

Recently, according to the CDE website, Hemay Pharma's Mometasone (Hemay005) has been submitted for marketing approval. Based on the clinical trial progress, it is speculated that the indication for this submission is plaque psoriasis.

It is reported that Mometasone is a small molecule inhibitor targeting phosphodiesterase 4 (PDE4) developed by Hemei Pharmaceutical. PDE4 can control the production of various downstream inflammatory factors by regulating intracellular cAMP and/or cGMP levels, so PDE4-targeted drugs have shown good therapeutic effects in a variety of inflammation-related diseases.

In December 2016, Mometasone Furoate entered the clinical stage for the first time. To date, Hemei Pharmaceutical has conducted two Phase III clinical trials on this drug, targeting plaque psoriasis and Behçet's disease, respectively.

Previously, Hemei Pharmaceuticals announced the Phase II study results of Molidustat for the treatment of Behçet's disease at the American College of Rheumatology (ACR) Annual Meeting. This study was a multicenter, randomized, double-blind, placebo-controlled clinical trial (n=90) that evaluated the efficacy and safety of Molidustat (45/60mg, twice daily) compared to placebo in patients with Behçet's disease.

The results of the Full Analysis Set (FAS) showed that Momelotinib 60mg (one-sided, P<0.0001) and 45mg (one-sided, P<0.0001) were significantly more effective than placebo in reducing the number of oral ulcers. The median healing time of oral ulcers estimated by the KM method was 16 days for the 45mg group and 15 days for the 60mg group. The median healing time for the placebo group could not be estimated using the KM method.

In the safety dataset (patients who received at least one dose of the study drug or placebo), the incidence of treatment-related adverse events (TEAEs) leading to discontinuation during the 12-week core treatment period was 6.9% in the 45mg group and 6.7% in the 60mg group, both higher than in the placebo group (0.0%). Most TEAEs reported during the core treatment period were mild. The incidence of serious TEAEs was dose-related, occurring at 3.3% in the 60mg group, and 0% in both the 45mg group and the placebo group.

Editor: Zheng Miao