Yoko Bian

Jan 10, 2025 | mondaq.com | Yoko Bian

On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with TabukPharmaceutical Manufacturing Company to commercialize BAT2206, aproposed ustekinumab biosimilar to Jansen's STELARA, in SaudiArabia. According to the partnership agreement, Tabuk will hold themarketing authorization and be responsible to manufacture,register, import, and market BAT2206 in Saudi Arabia, leveragingits strong local presence and expertise. Bio-Thera will handle thedevelopment and supply from China.

Jan 8, 2025 | jdsupra.com | Yoko Bian

On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia. According to the partnership agreement, Tabuk will hold the marketing authorization and be responsible to manufacture, register, import, and market BAT2206 in Saudi Arabia, leveraging its strong local presence and expertise.

Jan 7, 2025 | bigmoleculewatch.com | Yoko Bian

On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia. According to the partnership agreement, Tabuk will hold the marketing authorization and be responsible to manufacture, register, import, and market BAT2206 in Saudi Arabia, leveraging its strong local presence and expertise.

Dec 16, 2024 | jdsupra.com | Yoko Bian

On November 25, 2024, Intellia Therapeutics announced that its CRISPR-based therapy, nexiguran ziclumeran (nex-z, NTLA-2001), received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for treatment of hereditary transthyretin (ATTR) amyloidosis with polyneuropathy (ATTRv-PN). Nex-z is an in vivo gene editing therapy designed as a single-dose treatment to inactivate the TTR gene, thus preventing TTR protein production for the treatment of ATTR amyloidosis.

Nov 12, 2024 | mondaq.com | Yoko Bian

On October 30, 2024, Shanghai Henlius Biotech and Organon announced that the FDA has accepted the Biologic License Application (BLA) for HLX14, a proposed biosimilar to PROLIA/XGEVA (denosumab). In 2022, Shanghai Henlius Biotech granted Organon exclusive commercialization rights for HLX14 in the U.S., EU, and Canada. The filing for HLX14 is supported by data from studies including analytical assessments and two clinical trials.