Insulin Aspart Approval Adds Another Biosimilar to Pipeline
发布时间:2026-07-28 来源:华泰证券
Nanjing King-Friend Biochemical(King-Friend)announced on 27 July that its insulin aspart injection,partnered with Tonghua Dongbao,had received FDA approval.This is the company’s fourth biosimilar approval in the US,following adalimumab,liraglutide,and nab-paclitaxel.We think that the biosimilar business should underpin its long-term growth.Maintain BUY.
Insulin aspart:a resilient blockbuster;NKF top 3in biosimilars
Insulin aspart is arapid-acting insulin analog approved for glycemic control.Its originator,Novo Nordisk’s NovoLog,generated US sales of DKK7.17bn(USD1.13bn)in 2025.According to the company's announcement,the number of diabetic patients aged 20-79 in the US was 38.54mn in 2024 and is expected to reach 43.00mn by 2050,indicating substantial drug demand.Given that insulin is an essential therapy for some diabetic patients,we expect resilient demand amid an evolving competitive landscape.Currently,excluding King-Friend/Tonghua Dongbao,the only other manufacturers with approved insulin aspart biosimilars in the US are Sanofi and Biocon.The company partnered with Tonghua Dongbao in 2023 and submitted the BLA for insulin aspart in the US in July 2025.The approval took just 12 months,validating the efficiency of its R&D and registration systems.
Biosimilars:build the matrix via in-house R&D&cooperation
Biosimilars are becoming the company’s growth engine:1)It acquired an adalimumab biosimilar approval in June 2024,received approvals for liraglutide and nab-paclitaxel biosimilars in April/May 2025,and obtained approval for insulin aspart in July 2026.2)We expect other insulin products partnered with Tonghua Dongbao to receive approval in 2027.In addition,its biosimilar pipeline includes filgrastim and follicle-stimulating hormone.Given the trend of clinical trial waivers in the US,we expect the company to accelerate the expansion of its biosimilar matrix.Furthermore,the innovative drug XTMAB-16 has officially initiated Phase III clinical trials for pulmonary nodules.
Formulations:non-heparin exports gain traction
Formulation exports remain astrong growth driver:1)US formulation sales revenue grew by 27.39%YoY in 2025,with Meitheal generating revenue of RMB2.45bn(YoY+26.74%).2)By the end of 2025,it had secured over 100 overseas approvals,alongside three new US approvals YTD(including two from the Teva production transfer).3)Non-US markets are also gaining traction,with European formulation revenue surging by 70.88%YoY in 2025.Driven by the‘dual filing in China and the US’strategy,potential approvals are expected to roll out domestically:by end-2025,the company had obtained over 30 domestic approvals,with one additional approval YTD.
Earnings forecasts and valuation
We maintain our 2026E,2027E,and 2028E attributable net profit forecasts at RMB620mn,RMB778mn,and RMB1.03bn(YoY+6.59%,+25.44%,and+31.92%),with EPS of RMB0.38,RMB0.48,and RMB0.63.We apply 30.05x 2026E PE(in line with its peers’average on Wind consensus;previous:28.24x 2026E PE,also in line with its peers’average),deriving our fair valuation of RMB18.63bn and target price of RMB11.53(previously RMB10.83).
Risks:policy uncertainties,slower new product approvals and sales than we expect,FX risks.