Shanghai Ark Biopharmaceutical Co., Ltd.

ArkBio's AK3280 Shows Promising Results in Phase II IPF Trial with Significant Lung Function Improvement

15 days ago

• ArkBio's novel anti-fibrotic drug AK3280 demonstrated significant improvement in lung function during Phase II trials for idiopathic pulmonary fibrosis, with the highest dose group showing a 209.4 mL increase in FVC. • Unlike current IPF treatments that merely slow disease progression, AK3280 achieved actual improvement in respiratory function while maintaining a favorable safety profile without the gastrointestinal issues associated with existing therapies. • The multicenter, randomized study conducted across 31 clinical sites in China positions AK3280 as a potential breakthrough for IPF patients, with preparations now underway for pivotal Phase III clinical trials.

ArkBio's AK0901 Completes Phase III Trial for ADHD in China, Showing Significant Efficacy

2 months ago

• ArkBio has successfully completed Phase III clinical trials for AK0901, a novel methylphenidate-based drug for ADHD treatment, meeting all primary and secondary endpoints with statistical significance. • AK0901 combines immediate-release dexmethylphenidate with prodrug serdexmethylphenidate, offering improved symptom control and reduced blood concentration fluctuations compared to traditional treatments. • The drug addresses a significant unmet need in China, where ADHD affects 6.4% of children and adolescents—approximately 23 million individuals—with limited effective treatment options currently available.

NRx Pharmaceuticals Submits NDA Section to FDA for NRX-100 (Ketamine) in Suicidal Depression

5 months ago

• NRx Pharmaceuticals has filed the initial section of its New Drug Application (NDA) to the FDA for NRX-100 (ketamine) to treat suicidal depression. • NRX-100 aims to be the first FDA-approved medication for suicidal depression, addressing the needs of over 13 million Americans who contemplate suicide annually. • The FDA has requested the 1800-page manufacturing section for immediate review, with the complete NDA filing expected in the first quarter of 2025. • NRX-100 differs from anesthetic ketamine by excluding toxic preservatives and using diversion-resistant packaging to enhance medicine traceability.