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HanAll Biopharma Gets China Drug Approval
HanAll Biopharma secures first Chinese drug approval for batoclimab, starting royalty revenue in Greater China.
In brief
HanAll Biopharma secures first Chinese drug approval for batoclimab, starting royalty revenue in Greater China. HanAll Biopharma received China's National Medical Products Administration approval for batoclimab to treat generalized myasthenia gravis, marking the start of royalty revenue in Greater China. Originally…
HanAll Biopharma Wins First New Drug Approval in China
HanAll Biopharma has secured its first marketing approval for an autoimmune disease treatment through its Chinese partner.
“Batoclimab, an FcRn-targeting antibody that HanAll Biopharma licensed to Harbour BioMed in 2017, has received marketing approval from China's National Medical Products Administration as a treatment for generalized myasthenia gravis.”
Batoclimab Trial Results
In a Phase 3 trial across 27 Chinese hospitals, 58.2% of patients achieved an MG-ADL improvement of at least 3 points sustained for 4 weeks.
“The primary endpoint, the proportion of patients achieving an MG-ADL (activities of daily living) improvement of at least 3 points sustained for 4 weeks or more within the first treatment cycle, was 58.2% in the batoclimab arm, well above the 31.3% placebo rate (P=0.001).”
China's National Medical Products Administration Approval
China's National Medical Products Administration approved batoclimab for anti-acetylcholine receptor antibody-positive generalized myasthenia gravis in adults.
“China's National Medical Products Administration (NMPA) approved the subcutaneous formulation of batoclimab (170 mg/1 mL) submitted by Harbour BioMed (02142.HK) as a treatment for anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG) in adults, Harbour BioMed disclosed on the 23rd.”
Royalty Revenue Model
HanAll Biopharma receives approval milestones and royalties tied to net sales in Greater China.
“Under the existing agreement, HanAll Biopharma will receive approval milestones and tiered royalties tied to annual net sales in Greater China.”
Commercialization Partner
NBP Pharma, a subsidiary of CSPC Pharmaceutical Group, handles sales in Greater China.
“Commercialization in Greater China will be handled by NBP Pharma, a subsidiary of major Chinese pharmaceutical company CSPC Pharmaceutical Group.”
Market Outlook
China's myasthenia gravis treatment market is projected to grow from $30.3 million in 2025 to $62.1 million by 2033.
“According to market research firm Grand View Research, China's myasthenia gravis treatment market is projected to grow from $30.3 million in 2025 to $62.1 million by 2033.”
Competition and Challenges
Competition from earlier FcRn therapies such as Argenx's Vyvgart and UCB's Rystiggo remains a variable.
“In China, FcRn-mechanism therapies such as Argenx's Vyvgart and UCB's Rystiggo are already approved and on the market.”
The essence
HanAll Biopharma received China's National Medical Products Administration approval for batoclimab to treat generalized myasthenia gravis, marking the start of royalty revenue in Greater China.
