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Jiankang Yuan XYP-001, a novel drug for the treatment of idiopathic pulmonary fibrosis, has entered the clinical trial phase. This is a domestically unique improved drug.
Published Time：
2022-09-21
On the evening of September 20, HealthGen ( 10.18 -0.59% , Check Stock (600380.SH) announced that it recently received the "Drug Clinical Trial Approval Notice" for XYP-001 from the National Medical Products Administration, approving the clinical trial of this product for idiopathic pulmonary fibrosis.
HealthGen stated that XYP-001 is an improved new drug developed by the company, which was accepted on July 15, 2022, with the acceptance number CXHL2200508, intended for the treatment of idiopathic pulmonary fibrosis (IPF). If successfully developed, it will provide IPF patients with a new and safer treatment option. As of the announcement, the cumulative R&D investment in HealthGen's XYP-001 is approximately RMB 19.3 million yuan.
It is understood that IPF is a chronic progressive fibrosing interstitial pneumonia of unknown etiology, which is common in middle-aged and elderly people, progresses rapidly and has a poor prognosis, with a median survival time of only 2-3 years and a 5-year survival rate of <25%, and an incidence rate increasing by 11% annually. There are still no definitively effective treatment drugs. Currently, the anti-fibrotic drugs pirfenidone and nintedanib that are already on the market in China can slow down the progression of IPF, but cannot reverse the fibrosis process.
Pharmacokinetic studies have shown that XYP-001 can reduce the production of pulmonary fibrosis factors by inhibiting the activation of the fibrosis and inflammation signaling pathway P38-AKT protein, significantly reducing pulmonary fibrosis lesions. Animal experiments show that XYP-001 has a better anti-fibrotic effect than nintedanib and pirfenidone based on multiple fibrosis indicators. XYP-001 is administered by inhalation, which can directly and efficiently reach the target organ, the lungs, forming a high local concentration while having lower systemic exposure, and is expected to have fewer adverse reactions.
The development and approval of new drugs is good news for patients, bringing relief and effective treatment. XYP-001 is a new mechanism/target drug in the IPF indication development field. According to the CDE review center website and the Xinda database, as of now, there are no similar products declared, under clinical research, or approved for marketing in China. Only oral nintedanib and pirfenidone, which use different mechanisms of action to treat IPF, have been approved for marketing. According to IQVIA's sample statistical estimation data, the domestic terminal sales of pirfenidone in 2021 were approximately RMB 279 million, and nintedanib was approximately RMB 67 million.
In recent years, HealthGen has actively increased its R&D efforts for new products and innovation, driving development through innovation, adhering to the development concept of "For Health, For Tomorrow" and "Making Good Medicines with Care," focusing on patient interests, and being clinically valuable-oriented, focusing on R&D projects with high short-term certainty and cutting-edge technologies with long-term growth potential.
In 2021, HealthGen Group's R&D investment reached 1.85 billion yuan, a year-on-year increase of 46.75%. In terms of R&D investment scale for listed chemical pharmaceutical companies, HealthGen is second only to the hundreds of billions of yuan market value pharmaceutical giant.
In addition to the entry of the improved new drug XYP-001 into clinical trials, HealthGen has already obtained marketing approval this year for levalbuterol hydrochloride nebulization solution (3ml:1.25mg), sulfate terbutaline nebulization solution; recombinant novel coronavirus fusion protein vaccine Likang V-01 has been included in the sequential booster immunization emergency use; tobramycin inhalation solution (Class 2.4) has successfully completed supplementary research and is currently under review; fluticasone propionate nebulization suspension has submitted a marketing authorization application; salmeterol/fluticasone propionate inhalation powder has obtained a clinical trial approval notice and quickly launched Phase III clinical research; indacaterol maleate inhalation powder is conducting PD-BE research; formoterol fumarate inhalation aerosol is conducting Phase I clinical research, and the diversified product matrix competitive advantage is becoming increasingly prominent.
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