Feb. 27 Quick Takes: CSL readying HAE submission after garadacimab data 

CSL Ltd. (ASX:CSL) is planning a regulatory submission for garadacimab to prevent hereditary angioedema (HAE) attacks with new Phase III data suggesting comparable efficacy and less frequent dosing than marketed subcutaneous therapy Takhzyro lanadelumab from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK). In the Vanguard study, once monthly injections of garadacimab led to a mean attack rate reduction of 86.5% vs. placebo (p<0.001). During the six-month study, 24 (61.5%) of the patients treated with garadacimab and none of the 24 patients in the placebo arm were attack free. Takhzyro, which is also used to prevent HAE attacks rather than treat attacks as they occur, is generally injected every two weeks.

A Shenzhen Chipscreen Biosciences Co. Ltd. (Shanghai:688321) subsidiary gained exclusive clinical development and commercialization rights in Greater China to YH008, a bispecific antibody from the Eucure (Beijing) Biopharma Co. Ltd. subsidiary of Biocytogen Pharmaceuticals (Beijing) Co. Ltd. (HKEX:2315). Eucure will receive RMB40 million ($5.7 million) up front and is eligible for a development milestone of up to RMB360 million, a sales milestone payment of up to RMB196 million, as well as tiered royalties. Eucure Biopharma retains rights outside the area to develop and commercialize YH008, which targets PD-1 and CD40 to treat solid and hematologic tumors. An IND submission for the therapy has been cleared by FDA and accepted by China’s NMPA. ...