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BioWorld - Monday, June 15, 2026
Home » Authors » Elise Mak

Articles by Elise Mak

Shanghai, China
Chinatrials 12 Summit

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

Nov. 19, 2019
By Elise Mak
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.  
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Hands holding petri dish
Chinatrials 12 Summit

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

Nov. 19, 2019
By Elise Mak
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.
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Chinatrials 12 Summit

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

Nov. 19, 2019
By Elise Mak
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.
Read More
Chinese flag, charts
Chinatrials 12 Summit

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

Nov. 19, 2019
By Elise Mak
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.
Read More
Chinatrials 12 Summit

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

Nov. 19, 2019
By Elise Mak
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.
Read More
Chinatrials 12 Summit

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

Nov. 18, 2019
By Elise Mak
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.
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Beigene wins its first FDA nod with BTK inhibitor Brukinsa

Nov. 18, 2019
By Elise Mak
BEIJING – Beijing-based Chinese biotech giant Beigene Ltd. said Brukinsa (zanubrutinib) won accelerated FDA approval to treat adults with mantle cell lymphoma (MCL) who received at least one prior therapy. This is the first China-discovered innovative cancer drug to win FDA clearance.
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Chinatrials 12 Summit

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

Nov. 15, 2019
By Elise Mak
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.
Read More
Chinatrials 12 Summit

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

Nov. 14, 2019
By Elise Mak
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.
Read More
Chinatrials12 Summit

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

Nov. 13, 2019
By Elise Mak
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.
Read More
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