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再鼎医药(09688.HK):引进POVETACICEPT 进军国内IGA肾病市场

Zaiding Pharmaceutical (09688.HK): Introduces POVETACICEPT to enter the domestic IGA nephrology market

The company's recent situation

On January 10, 2025, the company announced that it had reached an exclusive cooperation and license agreement with Vertex Pharmaceuticals Incorporated (Vertex) to obtain the rights to develop and commercialize Povetacicept (Pove) in Greater China and Singapore.

reviews

POVE is currently the potentially best-in-class BAFF/April treatment for IgA nephropathy. According to the Vertex announcement, through the engineered TACI domain, POVE's affinity for BAFF and APRIL has improved markedly compared to other BAFF and/or APRIL antagonists. In November 2024, Vertex published Ruby-3 phase II clinical data for POVE treatment of IGA nephropathy. The baseline for enrollment was primary IgA nephropathy; UPCR≥0.5 g/g; EGFR≥30 ml/min/1.73 m2; receiving maximum dose RASI treatment for at least 12 weeks before administration. A total of 54 patients were enrolled, 21 received 80mg Pove SC Q4W, and 33 received 240mg Pove SC Q4W. The data showed 80mg Pove SC Q4W in the 48th week. The average decrease in UPCR in the treatment group was 66.0%, and the average EGFR in the 240 mg group decreased by about 80%. More importantly, the average EGFR in the 80 mg treatment group decreased by only 1.1 ml/min/1.73 m2 within 48 weeks, indicating that Pove was effective in maintaining stable kidney function in patients. Furthermore, unlike Tetacicept and Atacicept, which are administered subcutaneously once a week, Pove is administered subcutaneously every four weeks, which is expected to significantly improve patient compliance. Currently, many BAF and/or April target drugs for IgA nephropathy are in phase III clinical phase, including Pove, Taitacip, Atacicept, Zigakibart, Sibeprenlimab, etc., all showing positive phase II clinical data. We recommend focusing on subsequent data readings, especially the effects of reducing proteinuria and the transformation of long-term treatment into glomerular filtration rate benefits and improvement in renal function.

The R&D and commercialization layout of Pove and Agamod are highly collaborative, and future commercialization can be expected. According to estimates from the National Kidney Foundation, there are millions of patients with IgA nephropathy in China. About 20% to 40% of IgA nephropathy patients will progress to terminal nephropathy within 10-20 years after diagnosis. Long-term dialysis or kidney transplantation is required to maintain life. No specific treatment for the causes of IgA nephropathy has been approved in China. At present, China has joined the Pove Phase III MRCT study, and we believe that re-entry is expected to further accelerate domestic clinical trials. Furthermore, the company has verified its sales capability in the field of self-protection through the successful commercialization results of Agamod, so we are optimistic about Pove's future domestic commercialization potential.

Profit forecasting and valuation

We kept the company's profit forecast for 2024 and 2025 unchanged, and introduced a profit forecast of $0.029 billion for 2026. We maintain our outperforming industry rating, based on the DCF model, and switched to the 2025 valuation. We kept our target price unchanged at HK$28.10/$36.12 after exclusion, with 48.5%/42.8% upside compared to the current stock price.

risks

Approval and commercialization fell short of expectations, loss reversal progress was slower than expected, and pipeline clinical data fell short of expectations.

The translation is provided by third-party software.


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