With the FDA Nod in lung cancer, Dizal is now aiming for a J & J drug and to succeed where Takeda failed

One of the most competitive targets in lung cancer is a certain mutation that has escaped many targeted therapies available. A drug developed by Dizal Pharmaceutical has received the approval of the FDA for the treatment of patients whose disease presents this genetic signature, giving Shanghai based its first American product in Shanghai as well as the possibility of showing the differentiation of therapies generated by the laboratories of certain large pharmaceutical societies.

Dizal’s medication has been developed for the treatment of lung cancer not with small cells (NSCLC) which has an exon 20 insertion mutation in the EGFR gene. This genetic signature must be identified by a diagnosis of thermo fisher scientific companion. The FDA approved Wednesday evening. Treatment with the pill once a day of Dizal is approved for patients whose disease has progressed during or after treatment with chemotherapy. The drug, known in the development under the name of Sunvozertinib, will be marketed under the Zegfrovy brand.

The EGFR plays a key role in cellular processes in the body, but mutations in this protein can lead to the uncontrolled proliferation of cells that cause cancer. The best -selling EGFR inhibitor is Tagrisso d’Astrazeneca, a small oral molecule. But this successful medication against cancer was not effective against the insertion mutations of the EGFR 20 exon. The CEO of Dizal, Xiaolin Zhang, knows first. Before founding Dizal in 2017, his 20 -year career in Astrazeneca included work on Tagrisso.

Insertion changes in exon 20 stem from the insertion of genetic material in the EGFR gene. Zhang said Astrazeneca had tried to drug this target was to use higher doses of tagrisso. Although the tests of this approach have shown a certain activity, this has also led to unacceptable toxicity. The challenge for the drug transformation of the exon 20 insertion is that it is not a single mutation. Zhang said that insertions can occur in many ways and that research has revealed more than 120 types of this mutation, each according to the position of the gene and the size of insertion.

“One of the biggest challenges to design a molecule flexible enough to be able to inhibit all these different types of insertion changes?” He declared in an interview with the annual meeting of 2025 of the American Society of Clinical Oncology. “But also, you don’t want your compound to be too disknight so that it is not stable enough. This is the key challenge.”

Zegfrovy was discovered and developed internally by Dizal scientists, who designed the small molecule to target a wide range of EGFR mutations – not just exon 20 insertion mutations. Another key property of the drug: it is selective for mutant versions of the EGFR protein. An antibody can only approach the outside of its target. The problem is that the EGFR extracellular region is the same for normal and mutant EGFR forms. This means that an antibody intended for EGFR mutant medication can also affect normal degf, causing undesirable effects elsewhere in the body, Zhang said.

The FDA decision for Zegfrovy is an accelerated approval based on the results of a phase 2 study outdoors. In the efficiency population of 85 patients, the results showed that the overall response rate was 46% and the duration of the response was 11.1 months. A phase 3 confirmation study completed registrations. Zhang said this global study could support the use of Zegfrovy as a first -line treatment for admissible CNPNC patients. Dizal aims to file an FDA application seeking to extend the drug label early next year.

The first drug for the CPNPC led by the insertion changes in the EGFR 20 exon was rybler of Johnson & Johnson, which received accelerated approval in 2021 as a second -line treatment. This bispecific antibody blocks the EGFR and a second receiver called MET, which are both overexprimed in the surface of the surface of NSCLC cells. Last year, the FDA approved rybrovant for first -line use in this type of cancer, converting the status of the drug to complete approval.

Rybrevant is administered as an intravenous infusion which can take up to five hours. Dizal is one of the many pharmaceutical companies that work to develop small more practical oral molecules for the target. Takeda Pharmaceutical was the first to obtain accelerated FDA approval for oral medication for EGFR 20 INSERTION MUTATIONS, a regulatory decision that came from months after the accelerated approval of Rybrevant. But this drug, Exkivity, failed in its phase 3 confirmation study. Takeda voluntarily withdrew the exkivity of the market in 2023. Pharmaceutical spectrum did not even go so far. The FDA refused the small oral molecule of the spectrum, the poziotinib, in 2022.

There are other companies that are developing small oral molecules for exon 20 insertion changes. At the ASCO meeting, Cullinan Therapeutics said that she was planning FDA submission to the second half of this year for Zipalertinib. Similar to Dizal, the leaders of Cullinan say that their medication is more selective at the EGFR mutant. Biopharma arrive has reached clinical development at an advanced stage with its small oral molecule, Fironertinib. Around said that his medication can separate with properties penetrating to the brain which allowed him to treat the CNPPC which metastasized in the brain.

“There are a few others behind us, but for the second line [treatment of EGFR exon 20-mutated NSCLC]We are the leader, ”said Zhang.

Compared to the Rybrevant, Zhang said that the oral formulation of small molecules of Zegfrovy gives him safety and tolerability advantages. Despite this, the FDA noted that the warnings of the Dizal medication include an interstitial pulmonary disease and pulmonary inflammation; gastrointestinal problems; skin reactions; and eye toxicity. The medication is already available in commercial in China, where it was approved in 2023.

As for us. Marketing of Zegfrovy, Zhang said that his business had had discussions with potential partners. He noted that Dizal already has commercial infrastructure in China and that marketing strategies differ between East and West. In the United States, numerous biotechnology companies are unique active companies whose objective is to go beyond the drug or to be acquired by a large pharmaceutical company. In China, the wait is that a biotechnology company goes from discovery to marketing. Dizal has a second cancer drug marketed in China and a pipeline covering oncology and immunology.

“We have a commercial organization in China which is doing very well but, [in the] The United States and Europe, we will gradually develop our commercial presence because we have several assets and in the coming years, we are going to have three to five assets, “said Zhang.

Illustration: Mohammed Hanefna Nizamuden, Getty Images