The National Health Commission (NHC) of China has released an updated national list of rare diseases, doubling the number of conditions to 86, including 21 cancer types. This marks the first update to China’s orphan disease schedule since the initial list of 121 conditions was introduced in 2018.
Market Access and Drug Development Incentives
In recent years, China has been offering improved market access conditions to drug developers who secure approval for rare disease treatments. Since the establishment of the National Healthcare Security Administration in 2018, 26 rare disease therapies have been added to the National Reimbursement Drug List (NRDL), with an average price reduction of 50%. With additional drug access pathways, over 50 of the 75 rare disease drugs approved in China have some form of medical insurance coverage.
Industry Enthusiasm and Drug Indication Inclusion
There is an industry norm that a drug must be included in the rare disease list to be eligible for NRDL inclusion as a rare disease treatment. Unlike standard therapies, rare disease drugs have no recency limitation for market approval to be considered for NRDL inclusion, which is expected to boost industry interest in the updated list.
Beneficiaries and Oncology Indications
Initial analysis by Fineline Info & Tech suggests that likely beneficiaries from the second list include recent heavyweight approvals such as Boehringer Ingelheim’s Spevigo (spesolimab) for generalized pustular psoriasis, Kyowa Hakko Kirin’s Poteligeo (mogamulizumab) for cutaneous T cell lymphoma, and others. The 21 oncology indications in the new list are a significant increase from the initial 2, reflecting China’s first clear official definition of rare diseases issued in 2021: any disease with a neonatal incidence rate of less than 1/10,000, a prevalence rate less than 1/10,000, and a number of patients less than 140,000.
Companies and Treatments Targeting Rare Tumors
Companies like Bayer (ETR: BAYN), Amgen (NASDAQ: AMGN), Zai Lab (NASDAQ: ZLAB), CStone (HKG: 2616), BeiGene (NASDAQ: BGNE), and others with products targeting the listed tumors are set to benefit from the expanded rare disease list. The inclusion of these conditions is expected to spur further development and accessibility of orphan drugs in China.-Fineline Info & Tech
