BEIJING – China has updated its national reimbursement drug list (NRDL) to include innovative drugs that it has recently approved, including homegrown cancer drugs and foreign imports. Industry experts said they believe it is a move to drive biotech innovation at home.
SHANGHAI – As Chinese biotech companies talk more about innovation, one question is whether they are ready to move into first-in-class drugs from me-too and fast follow-up drugs. To biotech executives, the China first approval for Fibrogen Inc.'s roxadustat, a first-in-class small molecule for amenorrhea, is a wake-up call.
SHANGHAI – With abundant venture capital and favorable policies, Chinese biotech companies are actively turning themselves from generic makers into innovation-driven players, but the market is getting crowded by too many companies focusing on the same area and even the same targets, a reality that is leading to a lack of differentiation in biotech innovation.
SHANGHAI – Now is the time for foreign pharmaceutical companies to include China in their strategies, as the country's recent regulatory reform, vast patient pool and lower costs represent opportunities to score approvals faster, said experts at the Chinatrials12 Summit.
SHANGHAI – Innovation-driven biotech companies are sprouting up in China and they now aim to gain a bigger global presence through conducting clinical trials not just in their home country but also abroad.
BEIJING – Antibody developer Akeso Biopharma Inc., from China's Guangdong province, closed a $150 million series D financing round to advance its pipeline, especially the two PD-1-based bispecific antibodies, AK-104 and AK-112, aimed to help it stand out in the fierce PD-1 space in China. "A significant portion of the proceeds will go to AK-104 and AK-112, which are both first-in-class drug candidates," Akeso CEO Michelle Xia told BioWorld. This year is a big one for Akeso, as AK-104 and AK-112 received IND approvals from the FDA in March and July, respectively.
BEIJING – Chinese drug regulators granted conditional approval to Shanghai Green Valley (Group) Co. Ltd.'s marine-derived oligosaccharide, GV-971, to treat Alzheimer's disease (AD), but required further trials to prove the drug's efficacy after marketing.
SAN FRANCISCO – At what BIO CEO and President Jim Greenwood called a "Dickensian moment in the history of biotechnology – arguably the best of times and the worst of times" for U.S. industry players, new rules piloted by the Committee on Foreign Investment in the U.S. (CFIUS) have made things even more challenging.
BEIJING – Cell therapies specialist Nanjing Iaso Biotherapeutics Co. Ltd. became the latest Chinese biotech to enter the country's fierce CAR T race, after China regulators granted an IND approval to CT-103A, a fully human BCMA CAR T for treating relapsed or refractory multiple myeloma.
HONG KONG – Hutchison China Meditech Ltd.'s (Chi-Med) is preparing for the next step after surufatinib achieved its primary endpoint in a phase III SANET-ep study in extra-pancreatic advanced neuroendocrine tumors (NETs) in China.
RSS
