# HanAll Biopharma Gets China Drug Approval

> HanAll Biopharma secures first Chinese drug approval for batoclimab, starting royalty revenue in Greater China.
- Title: HanAll Biopharma Gets China Drug Approval · BigGo Finance
- Summary: HanAll Biopharma secures first Chinese drug approval for batoclimab, starting royalty revenue in Greater China. HanAll Biopharma received China's National…
- Keywords: hanall biopharma, batoclimab, generalized myasthenia gravis, fcrn, nmpa, greater china, royalty revenue, seahawks, finance, markets, HanAll, Biopharma
- Source: BigGo Finance — https://finance.biggo.com/news/c5d83d47-07aa-4a59-bda7-002e3672e480
- Author: BigGo Finance
- Published: 2026-10-23T02:25:20+00:00
- Read time: 1 min
- Topics: hanall biopharma, batoclimab, generalized myasthenia gravis, fcrn, nmpa, greater china, royalty revenue, seahawks, finance, markets
## 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.
## Key takeaway

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.