Focus On Asia

If finally fully approved in its first indication, the HGF gene therapy could become a first-in-class therapy for PAD - but only after years of challenges in clinical trials.

Parexel’s chief strategy officer Kushal Gohil, Clinical EVP Stephen Pyke and India head Sanjay Vyas share thoughts on possible hurdles to, and the cascading impact of obesity treatments, GenAI progress and the opportunities and challenges of real-world data in India, in the second of this two-part interview with Scrip.

Positive clinical outcomes for Hengrui and Innovent/Lilly’s obesity candidates presented at ADA were based on trials that enrolled Chinese subjects and were characterized by fewer women and less severe obesity than similar Western studies. Even so, some of the data appear to stack up well against western rival drugs.

In this Chinese-language podcast episode, "Angus" Shipo Xie, a lawyer at Han Kun Law, joins Brian Yang to discuss the implications of China's updated Data Overseas Transfer rules issued in late March. Dexter Yan explains clinical data released by Hutchmed, Jiangsu Hengrui and Innovent Bio at the recent EHA and ADA annual conferences.

SanBio’s lead cell therapy asset has been on a bumpy journey to its global-first approval and while a nod has now come in Japan in a high-need indication, a commercial launch is conditional on additional data to establish product equivalence and manufacturing consistency. 

As India seeks to build on early gains in CAR-T cell therapy, experts call for ecosystem reform and also the need to demonstrate value to payer models of large economies to potentially back international reimbursements.

SK pharmteco CEO Joerg Ahlgrimm talks to Scrip about the "excitement" at BIO, potential CDMO shifts amid the US BIOSECURE Act, and the Korean CDMO's focus on business as usual as it seeks to diversify and grow.

China's Dizal has won the first approval worldwide, in its home market, for a JAK1 inhibitor in relapsed/refractory peripheral T-cell lymphoma (PTCL), based on a pivotal Phase II trial. The biotech is also planning a Phase III study with the molecule for second-line PTCL.

With no approved therapies globally for Stargardt's, competition in the indication is increasing in Japan, where Kubota Vision is seeking for conditional approval for emixustat, while Belite Bio’s contender tinlarebant has received Sakigake designation as a local Phase III program continues.

Parexel’s chief strategy officer, clinical EVP and India head share thoughts on a winner’s mindset for artificial intelligence, benefits of a “federated approach” to clinical data sharing, support for reimbursement and a cascading impact of obesity treatments, in a two-part interview with Scrip.

Takeda has signed an option deal for Ascentage's olverembatinib, being investigated in two global Phase III trials in the same leukemia indications as those for the Japanese firm's existing drug Iclusig. Olverembatinib has also shown potential to overcome resistance to Iclusig and global competitor Novartis's Scemblix.

Academia-developed novel oral PAI-1 inhibitor in combination with Opdivo showed a strong response rate in PD-1 treated melanoma patients with certain disease characteristics and could represent a new breakthrough for a class with no clinical stage competitors. 

The Phase III ESLIM-01 study with HUTCHMED’s Syk inhibitor sovleplenib met its primary endpoint, demonstrating a 48.4% durable response rate for chronic immune thrombocytopenia, significantly higher than placebo. Global development appears to be accelerating and a multinational dose-finding Phase Ib study has also been initiated.

Plus deals involving Kissei/JWP, Shionogi/Cilcare, Takeda/Torrent, Genome & Co./Debiopharm, Kaken/J&J, CStone/Ewopharma, MediLink/BioNTech and more.

Sun’s CEO (North America) Abhay Gandhi tells Scrip how not many gave the firm a chance in the US with Ilumya, now with global sales of over half a billion dollars, and outlines prospects of deuruxolitinib for alopecia areata. India’s top-ranked drug maker also has an eye on China R&D assets.

In a late-breaker oral presentation at ASCO on the SCORES study with suvemcitug, Simcere revealed a trend favoring an overall survival advantage in platinum-resistant oral cancer, despite immature data.