FINWIRES · TerminalLIVE
FINWIRES

Celltrion Wins US FDA Nod for RA Trial of Zymfentra

By

Celltrion (KRX:068270) received U.S. Food and Drug Administration approval to launch a Phase 3 clinical trial in the U.S. for Zymfentra (CT-P13 SC), a subcutaneous version of its infliximab biosimilar, in patients with rheumatoid arthritis.

The study will enroll 296 patients over 52 weeks and aims to demonstrate superiority to placebo in reducing disease symptoms by Week 12. Zymfentra is already approved in several countries for ulcerative colitis and Crohn's disease, and the new trial could extend its use to rheumatoid arthritis.

Celltrion said the US FDA does not issue separate approval notices for new Phase 3 trials, with confirmation deemed effective 60 days after submission.

What else is happening in Asia?

Asia

Shenzhen Megmeet Electrical Buys Out 46.3% Stake in Subsidiary

Shenzhen Megmeet Electrical (SHE:002851) will purchase the remaining 46.3% stake it does not own in subsidiary Shenzhen Megmeet Welding Technology for 663.6 million yuan, according to a Wednesday filing with the Shenzhen bourse.Following the sale of the stakes of 46 shareholders, the listed company will fully own the subsidiary.

SHE:002851
Asia

Zhejiang Wanliyang Appoints CFO

Zhejiang Wanliyang (SHE:002434) appointed Shi Yuqiong as chief financial officer after Zhang Leigang resigned from the top financial role due to a change in work responsibilities, according to a Shenzhen bourse filing on Wednesday.Shi's appointment came into effect on Tuesday. The term runs through the end of the current board's tenure.Qian Shouguang was also appointed head of the internal audit department after the previous department head resigned, the filing said.Shares of the Chinese auto transmission systems manufacturer fell over 2% in recent trade.

SHE:002434
Asia

Carimin Petroleum Raises Stake in Sealink International to 25.3%

Carimin Petroleum (KLSE:CARIMIN) acquired a 5.8% stake in Sealink International (KLSE:SEALINK) for 9.9 million ringgit in cash, according to a Tuesday filing with Bursa Malaysia.The acquisition involved 29.1 million shares bought at 0.34 ringgit each, between Sept. 18 and Sept. 22.Following the acquisition, Carimin's stake in Sealink rose to 25.3% from 19.5%, making Sealink an associate company.Carimin Petroleum said the acquisition was part of its ongoing investment strategy.The deal was funded through internally generated funds and does not require shareholder or regulatory approval, the filing said.

KLSE:CARIMINKLSE:SEALINK