Novartis Submits IND Application in China for KFA115, a Novel Class 1 Oncology Drug Candidate

Today (August 16), according to the CDE official website, the clinical trial application of Novartis' Category 1 chemical drug KFA115 has been accepted. Public information indicates that this drug is a new medication for cancer treatment.

Source of the image: CDE official website

Novel Immunomodulators
Overseas Clinical Trials Have Begun

As China's population aging intensifies, the number of cancer patients is increasing year by year. It is estimated that the number of new cancer cases in China has exceeded 4.9 million in 2023. By 2025, the global anti-tumor drug market size is expected to reach $266.4 billion; the market size of China’s anti-tumor drug industry is expected to reach 559 billion yuan by 2029, with a compound annual growth rate of approximately 19% from 2024 to 2029.

At the same time, to meet the huge market demand, more and more new anti-tumor drugs are being launched. KFA115 is a novel immunomodulator developed by Novartis for the treatment of solid tumors. Currently, Novartis is conducting a Phase I clinical study of KFA115 overseas, aiming to determine the safety and tolerability of KFA115 as monotherapy and in combination with pembrolizumab in patients with advanced cancer, and to identify the maximum tolerated dose and/or recommended dose. The study is expected to be completed by 2026, with a planned enrollment of 180 participants.

Image Source: clinicaltrials.gov

If KFA115 successfully obtains clinical trial approval from the CDE, Novartis may initiate further research on it in China.

MET、IL-17A…
New Drug Development Accelerates

Recently, Novartis released its 2024 Q2 financial report, with net sales of $12.5 billion, representing an 11% year-over-year increase. Meanwhile, Novartis is accelerating the development progress of its subsequent pipeline, and multiple drugs under research have made new advancements in 2024.

Image Source: Novartis

Yipukelan Hydrochloride Capsules

Iptacopan is an inhibitor of the complement alternative pathway. It received accelerated FDA approval earlier this month for reducing proteinuria (generally referring to a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g) in adult patients with primary IgA nephropathy (IgAN) at risk of rapid progression. Activation of the complement alternative pathway is considered one of the pathogenic mechanisms of IgAN, and iptacopan hydrochloride capsules can effectively target the complement alternative pathway of the immune system to treat related diseases. In April this year, the drug received NMPA approval for marketing in China, with an indication for paroxysmal nocturnal hemoglobinuria (PNH).

Capmatinib Hydrochloride Tablets

Capmatinib is a specific MET receptor tyrosine kinase inhibitor that received NMPA approval for marketing in China this June. It is indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor (MET) exon 14 skipping mutations who have not received systemic treatment. According to publicly available information, capmatinib was first approved by the U.S. FDA for marketing in May 2020. To date, it has been launched in Japan, the European Union, Switzerland, Brazil, Singapore, and other countries and regions.

Secukinumab

Secukinumab, an IL-17A inhibitor, was approved by the NMPA in January this year for the treatment of adult patients with active psoriatic arthritis. Previously, secukinumab had already been approved in China for the treatment of moderate to severe plaque psoriasis and ankylosing spondylitis. In 2020, secukinumab was officially included in the National Reimbursement Drug List (NRDL).

In addition, Novartis has carried out multiple transactions to expand its presence in the fields of radioligand therapy and prostate cancer treatment. Notably, Novartis' project for the production of radiopharmaceuticals in China officially commenced construction in July.

Conclusion

Novartis mentioned in its 2024 Q2 report that it has raised the full-year forecast for 2024 based on the strong growth momentum of its key growth engine drugs. Meanwhile, by accelerating the development of subsequent pipelines, Novartis is expected to achieve more innovative results.

Editor: Mu Mian

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