Challenging the rare target of “difficult to obtain drugs”, this new lung cancer drug sold for 173 million yuan in seven months of its launch

At present, chemotherapy is still the main first-line treatment for the EGFR Exon20ins target in clinical practice. Traditional EGFR small molecule targeted drugs and immunotherapy have attempted to overcome the EGFR Exon20ins mutation, but all have been unsuccessful. Even if the dosage of the third-generation EGFR TKI is doubled, the efficacy is still poor.

The EGFR exon20ins mutation target is widely recognized as a rare target of difficult to treat drugs, and this type of mutation accounts for about 2% -4% in non-small cell lung cancer, which has long lacked effective standard treatment in this field.

Last August, Shuwozhe (Shuwotinib) from Dizhe Pharmaceutical (688192. SH) was approved for marketing in China, filling the clinical treatment gap in this field for nearly 20 years. It is also the only targeted drug in China that has been approved for the indication of EGFR exon20ins mutant non-small cell lung cancer. How has this drug been commercialized since its launch?

On the evening of April 29th, Dizhe Pharmaceutical released its annual report for 2023 and the first quarter report for 2024, with a revenue of 91.29 million yuan in 2023; The operating revenue for the first quarter of 2024 was 81.32 million yuan.

Due to the fact that Dizhe Pharmaceuticals only commercializes its products with Shuwozhe, the above-mentioned revenue is also equivalent to Shuwozhe’s sales revenue. In total, after about seven months of listing, the drug’s sales reached 173 million yuan.

In other words, in its first year of listing and not yet covered by medical insurance, Shuwotini has achieved an average monthly sales revenue of nearly 25 million yuan.

However, against the backdrop of high R&D investment in the company, Dizhe Pharmaceutical has not yet achieved a turnaround, with a net profit loss of 1.108 billion yuan attributable to the listed company in 2023; In the first quarter of 2024, the net profit attributable to the listed company suffered a loss of 224 million yuan, a year-on-year decrease of 6% and a month on month decrease of 20%.

Photo source: screenshot of Dizhe Pharmaceutical’s official account

Dizhe Pharmaceutical told First Financial reporters that for its core product, Shuwozhe, the company will effectively utilize funds to accelerate global clinical trials and expand indications, in order to achieve greater product value and expand its own hematopoietic capacity. According to the plan, it will achieve comprehensive profitability in 2027.

At present, chemotherapy is still the main first-line treatment for the EGFR Exon20ins target in clinical practice. Traditional EGFR small molecule targeted drugs and immunotherapy have attempted to overcome the EGFR Exon20ins mutation, but all have been unsuccessful. Even if the dosage of the third-generation EGFR TKI is doubled, the efficacy is still poor. Therefore, some market participants believe that there is a large amount of unmet clinical demand in this field.

Dizhe Pharmaceuticals told First Financial reporters that since its establishment, the company has regarded global source innovation as its core strategy. Source innovation barriers avoid homogeneous market competition and can establish a good market competition pattern for the company’s products.

It is reported that Dizhe Pharmaceuticals also has an innovative drug, namely Golixitinib, which has been included in the priority evaluation when it is applied for marketing in China. This drug is the world’s first and only highly selective JAK1 inhibitor targeting T-cell lymphoma. If launched, it is expected to break through the treatment dilemma of relapsed and refractory peripheral T-cell lymphoma.

Di Zhe Pharmaceutical stated that Golixitinib is expected to be approved for market launch in the first half of this year. The company plans to promote the inclusion of two drugs, Shuwozhe and Golixitinib, in the medical insurance catalog this year. If they are successfully included in the medical insurance catalog, they are expected to experience commercial expansion.

In recent years, the domestic biopharmaceutical industry has experienced a capital winter, which directly poses certain challenges to seeking external financing.

“The company hopes to launch scientifically confident products to the market as soon as possible and accelerate the realization of self generating capabilities. The company will also actively evaluate opportunities for external cooperation with multinational companies regarding products. The company will evaluate from various dimensions such as pipeline synergy, global commercialization ability, development potential, cash flow, etc., and seek the best solution that is in line with the interests of the company and all shareholders.” said Dizhe Pharmaceutical.

-