Calliditas' Partner Everest Medicines Starts Commercial Launch of Nefecon in China

Rhea-AI Summary

Calliditas Therapeutics (Nasdaq: CALT) announced that its partner, Everest Medicines, has launched Nefecon® in China. China has up to 5 million patients with IgA nephropathy (IgAN), a progressive autoimmune disease. IgAN accounts for 35% to 50% of primary glomerular diseases, with over 100,000 new cases yearly. The Phase 3 NefIgArd trial showed a 66% reduction in kidney function loss in Chinese patients treated with Nefecon, outperforming global results.

Nefecon received conditional approval from China’s National Medical Products Administration (NMPA) in November 2023 and has since been launched in Macau, Hong Kong, and Singapore. The drug is also under review in Taiwan and South Korea.

Positive

• Launch of Nefecon® in China targets up to 5 million IgAN patients.
• Chinese Phase 3 trial showed 66% reduction in kidney function loss, better than global data.
• Conditional approval from China's NMPA in November 2023.
• Nefecon® also launched in Macau, Hong Kong, and Singapore.
• New Drug Applications under review in Taiwan and South Korea.

Negative

• High unmet medical need indicates significant competition and market entry challenges.
• Focus on Asian markets may limit immediate global revenue potential.

Insights

Medical Research Analyst

The commercial launch of Nefecon in China is particularly noteworthy in the field of nephrology, given the high prevalence of IgA nephropathy (IgAN) in the region. IgAN is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) lodges in the kidneys, leading to inflammation. The fact that the Chinese subpopulation showed a more pronounced treatment effect in the Phase 3 NefIgArd trial indicates that Nefecon could offer a significant therapeutic advantage in this region. The reduction in loss of kidney function by approximately 66% in the Chinese cohort, compared to 50% globally, underscores the potential for better clinical outcomes for patients with this specific demographic profile. Investors should note the potential for expanded indications and further research into the genetic or environmental factors contributing to this enhanced efficacy.

Financial Analyst

From a financial perspective, the launch of Nefecon in China opens a substantial new market for Calliditas and its partner, Everest Medicines. With China having an estimated 5 million IgAN patients, the patient base is vast. Given that the drug has already gained conditional approval from China's National Medical Products Administration (NMPA) and has also been launched in Macau, Hong Kong and Singapore, the revenue potential is substantial. The data showing improved efficacy in the Chinese cohort could also drive accelerated adoption in these markets. Investors should consider the potential revenue growth from these new markets, balanced against the costs of commercialization and potential competition. The approval and launch in multiple Asian territories suggest a robust market strategy and a positive trajectory for future financial performance.

Market Research Analyst

The introduction of Nefecon into the Chinese market responds directly to a substantial unmet medical need, suggesting a high demand and swift uptake. With IgAN accounting for 35% to 50% of primary glomerular disease cases in the region, the market penetration for Nefecon could be significant. The phase 3 trial results presenting a 66% reduction in loss of kidney function in Chinese patients highlight a compelling product differentiation that could provide a competitive edge. Moreover, the regulatory environment in Asia appears favorable, with approvals in China, Macau, Hong Kong and Singapore and pending reviews in Taiwan and South Korea. This broad regulatory acceptance not only bolsters market confidence but also indicates potential for further geographic expansion. Retail investors should find the market dynamics favorable, given the high disease prevalence and robust trial results.

STOCKHOLM, May 14, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announces that its partner Everest Medicines (HKEX: 1952.HK) ("Everest") has launched Nefecon^® in China.

China, which is estimated to have up to 5 million patients suffering from the progressive autoimmune disease, IgA nephropathy (IgAN), has the highest prevalence of primary glomerular diseases in the world, with IgAN accounting for about 35% to 50% of cases with a biopsy proven incidence of over 100,000 patients per year. There is a very significant unmet medical need for novel therapies among IgAN patients in China and other Asian countries.

"This is a fantastic result from many years of dedication and hard work by teams from both companies and I am delighted that patients in China now can benefit from Nefecon, which has been specifically designed to address the origin of IgAN," said Renee Aguiar-Lucander, CEO.

Results from the Chinese subpopulation analysis of the Phase 3 NefIgArd trial, presented at the American Society of Nephrology (ASN) Kidney Week in 2023, provided evidence that the treatment effect of Nefecon in the Chinese cohort was greater than in the global data set with regards to kidney function, proteinuria and microhaematuria. In the Chinese cohort, the mean absolute change from baseline in estimated glomerular filtration rate (eGFR) at 24 months showed an approximately 66% reduction in loss of kidney function with Nefecon over the period, compared with a 50% reduction in loss of eGFR in the global data set.

Nefecon® was awarded conditional approval in IgAN by China's National Medical Products Administration (NMPA) in November 2023. In addition to being approved and commercially launched in Mainland China, Nefecon® has also received approval in Macau, Hong Kong and Singapore, and was successfully commercially launched and first prescribed in Macau at the end of last year.  New Drug Applications (NDA) for Nefecon® were also successfully accepted for review in Taiwan and South Korea at the end of 2023.

For further information, please contact:
Åsa Hillsten, Head of IR & Sustainability, Calliditas
Tel.: +46 76 403 35 43, Email: asa.hillsten@calliditas.com

The information was sent for publication, through the agency of the contact persons set out above, on May 14, 2024 at 13:00 p.m. CET.

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SOURCE Calliditas Therapeutics

FAQ

What is Calliditas Therapeutics' stock symbol?

Calliditas Therapeutics' stock symbol is CALT.

What is Nefecon designed to treat?

Nefecon is designed to treat IgA nephropathy (IgAN), a progressive autoimmune disease affecting the kidneys.

What were the Phase 3 trial results for Nefecon in China?

The Phase 3 NefIgArd trial in China showed a 66% reduction in kidney function loss, compared to a 50% reduction in global data.

When did Nefecon receive conditional approval in China?

Nefecon received conditional approval from China's National Medical Products Administration (NMPA) in November 2023.

In which other regions has Nefecon been launched?

Nefecon has also been launched in Macau, Hong Kong, and Singapore.

Are there any ongoing reviews for Nefecon in other countries?

Yes, New Drug Applications for Nefecon are under review in Taiwan and South Korea.