Green light for a drug against lung cancer from the Spanish company PharmaMar

AdminDecember 3, 2024

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Green light for a drug against lung cancer from the Spanish company PharmaMar

PharmaMar announced that it would sell its drug for lung cancer, Zepzeltsa (lurbinectin) in China after receiving conditional approval National Medical Products Administration of this country (NMPA). This advancement will go hand in hand with Luye Pharmawith whom the company entered into an agreement agreement for milestone payments and sales royalties earned at the Asian giant.

Strategic Agreement

The alliance between PharmaMar and Luye Pharma also involves the commercialization of Zepzelka in Hong Kong And Macau. With this approval, PharmaMar reaches a total of 17 countrieshighlighting USAwhere the drug received accelerated approval in 2020 and is already accumulating over 241 million dollars in sales.

Zepzelka, second-line drug

Zepzelka is a drug used in second line for lung cancer, that is, when initial treatment is unsuccessful. Its approval in China conditionalbecause it is based on results Phase II trialsand regulators are waiting for more data before final approval. This condition also applies in other countries where the drug is approved.

A clinical trial in China confirms the effectiveness of the drug

Zepzelka’s approval in China is based on data obtained from a clinical trial conducted in the country. The study was conducted on Chinese patients with progressive solid tumorsincluding recurrent small cell lung cancer. The primary objective was to evaluate the safety, tolerability, pharmacokinetics, and efficacy of the drug, and the data were successful. These results complement those obtained in the study FDA in the USAwhich also used a single-arm, multicenter, open-label clinical trial conducted in 105 adult patients with recurrent metastatic small cell lung cancer. These data from both studies confirm efficiency and safety Lurbinectidine in lung cancer patients in different contexts and regions.

Lung cancer in China: a growing health problem

He lung cancer still leading cause of death cancer in China, where more than a million new cases are diagnosed annually and 733,291 deathsWith. From these cases small cell lung cancerwhich represents from 10% to 15% global diagnoses, especially aggressive and difficult to treat. High caseload means Zepzelc is expecting powerful coverage in an Asian country.

PharmaMar shares rose almost 7% on the stock market

Following China’s approval of the drug, Zepzelka is now available in 17 countries around the world, sending PharmaMar shares soaring. almost up to 7% immediately after the Spanish company announced it.