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Chinatrials 12 Summit

Is China ready for first-in-class? Not quite, but we must go ahead with innovation, experts say

November 19, 2019

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.

Chinatrials 12 Summit

Too many PD-1s? Facing a competitive landscape, Chinese firms seek ways to stand out

November 19, 2019

By Elise Mak

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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.

Chinatrials 12 Summit

Foreign pharma can leverage China’s regulatory pragmatism, patients and lower trial costs

November 19, 2019

By Elise Mak

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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.

Chinatrials 12 Summit

China looking to close gap in cell therapy market; CAR T development advancing fast

November 19, 2019

By Elise Mak

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SHANGHAI – Although China still has a way to go to approve any CAR T therapy, clinical development is robust with various targets being studied, and the regulatory environment is improving, cell therapy experts said at the Chinatrials 12 Summit.

Chinatrials 12 Summit

Is China ready for first-in-class? Not quite, but we must go ahead with innovation, experts say

November 18, 2019

By Elise Mak

No Comments

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. Biotech executives said China still lacks the comprehensive ecosystem to support such time-consuming and high-risk R&D, but it is time to do so and they must go ahead.

Chinatrials 12 Summit

Too many PD-1s? Facing a competitive landscape, Chinese firms seek ways to stand out

November 15, 2019

By Elise Mak

No Comments

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.

Chinatrials 12 Summit

Foreign pharma can leverage China’s regulatory pragmatism, patients and lower trial costs

November 14, 2019

By Elise Mak

No Comments

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.

Chinatrials12 Summit

With the help of trial experts, Chinese biotechs set sail for global market

November 13, 2019

By Elise Mak

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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.

Akeso closes $150M series D to advance first-in-class bispecific antibodies

November 7, 2019

By Elise Mak

No Comments

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.

China grants conditional approval to Green Valley's GV-971 for Alzheimer's disease

November 6, 2019

By Elise Mak

No Comments

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.

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Is China ready for first-in-class? Not quite, but we must go ahead with innovation, experts say

Too many PD-1s? Facing a competitive landscape, Chinese firms seek ways to stand out

Foreign pharma can leverage China’s regulatory pragmatism, patients and lower trial costs

China looking to close gap in cell therapy market; CAR T development advancing fast

Is China ready for first-in-class? Not quite, but we must go ahead with innovation, experts say

Too many PD-1s? Facing a competitive landscape, Chinese firms seek ways to stand out

Foreign pharma can leverage China’s regulatory pragmatism, patients and lower trial costs

With the help of trial experts, Chinese biotechs set sail for global market

Akeso closes $150M series D to advance first-in-class bispecific antibodies

China grants conditional approval to Green Valley's GV-971 for Alzheimer's disease

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