New Player Enters the Lung Cancer Treatment Field in China. With the approval of its new drug, Amivantamab Injection (brand name: RYBREVANT), for lung cancer indications, Johnson & Johnson has officially entered the lung cancer treatment market in China. The drug targets EGFR exon20ins, a globally recognized difficult-to-treat mutation, and currently, there are only three targeted drugs approved worldwide in this field. Following the withdrawal of Takeda Pharmaceutical's Mobocertinib, Johnson & Johnson will now compete head-to-head with Dizal in this domain.
Johnson & Johnson Enters the Lung Cancer Treatment Field
Information from the official website of the National Medical Products Administration shows that RYBREVANT (R) recently received approval for use in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test.
Notably, the approval of Carestream Health also signifies Johnson & Johnson's official entry into the field of lung cancer treatment in China. Lung cancer ranks first in both incidence and mortality among all malignant tumors in China. Public data shows that there are over 1 million new cases of lung cancer each year in China. Non-small cell lung cancer (NSCLC) is the most common type, accounting for approximately 85% of all lung cancer cases, with EGFR gene mutations being the most prevalent driver mutation in NSCLC. About 40% of patients in China carry this mutation. Currently, around 25%-40% of patients with EGFR mutations cannot proceed to second-line treatment due to severe disease progression. EGFR exon 20 insertion mutations (EGFR exon20ins) represent the third most common mutation type. Generally, NSCLC driven by this mutation has a poorer prognosis and shorter survival compared to lung cancers driven by common EGFR mutations.
EGFR exon20ins has always been a globally recognized difficult-to-treat target. To date, only three drugs targeting EGFR exon20ins NSCLC have been approved for marketing worldwide: Takeda's Mobocertinib, Johnson & Johnson's Amivantamab, and Dizal's Sunvozertinib (brand name Sunvozhe). However, in October 2023, following consultations with the U.S. Food and Drug Administration (FDA), Takeda announced the withdrawal of the already approved indication for Mobocertinib, which was used to treat epidermal growth factor receptor (EGFR).Exon20For adult patients with insertion mutation-positive (insertion+) locally advanced or metastatic non-small cell lung cancer whose disease has progressed during or after platinum-based chemotherapy. This means that in the global market, this field will see competition between Johnson & Johnson and Dizal.
The Competition in the $2 Billion Market
In terms of market space, according to Frost & Sullivan estimates, patients with EGFR exon20ins mutations account for about 10% of NSCLC cases. By 2030, the global market size for EGFR-TKIs is projected to reach $23.2 billion, and with a 10% share, the market size of this segment could be no less than $2 billion. Takeda once predicted that the peak sales of Mobocertinib would reach $300-$600 million.
The approval status of the two drugs in China is slightly different. Sunvozertinib was approved for marketing by the National Medical Products Administration in August 2023. It is approved for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy, or are intolerant to platinum-based chemotherapy, and whose tumors have been confirmed to have EGFR exon20 insertion mutations (EGFR exon20ins). The drug is still advancing in first-line treatment. On February 5, Dizal disclosed,DizalSingle-agent first-line treatment for EGFR exon20ins NSCLC demonstrates potent and durable anti-tumor activity, with a confirmed objective response rate (ORR) of 78.6%. Currently, the international multicenter clinical study of Sunvozertinib as a first-line treatment for non-small cell lung cancer carrying EGFR exon20ins is proceeding actively. In 2024, it is estimated that two innovative drugs, including Sunvozertinib, will bring Dizal 360 million yuan in revenue.
The approval of Amivantamab is based on the results of the randomized, open-label, PAPILLON Phase III clinical trial. The study demonstrated that, compared to chemotherapy alone, the combination of amivantamab and chemotherapy reduced the risk of disease progression or death by 61%. Based on this, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines recommend amivantamab in combination with chemotherapy as the preferred first-line treatment for patients with EGFR exon20 insertion-positive non-small cell lung cancer.
Dizal's progress is also very rapid. In January this year, Dizal disclosed that the new drug application for Sunvozertinib, used for adult patients with locally advanced or metastatic non-small cell lung cancer carrying epidermal growth factor receptor exon 20 insertion mutations who have previously received platinum-based chemotherapy, was accepted by the National Medical Products Administration. It is the first and only Class 1 new drug in the lung cancer field to receive "Breakthrough Therapy Designation" in both China and the United States.
Whether in the Chinese market or overseas, the competition between the two drugs is inevitable. Due to the difficulty of research and development, there are not many companies in this field. According to publicly available information compiled by reporters, apart from Johnson & Johnson and Dizal, about 20 companies are currently involved, including Ailis and CSPC. Among them, the new drug application for Poziotinib, co-developed by Hanmi Pharmaceuticals and others, was rejected by the FDA. Furmonertinib by Ailis has initiated registration clinical trials for second-line treatment indications within China. For first-line treatment indications, as of the end of October 2024, clinical research has been carried out in multiple countries and regions, including China, the United States, Japan, and Europe.
Xinhua News Agency reporter Zhang Xiulan
Proofread by Yang Xuli