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1 week ago | 
insights.citeline.com | Andrew McConaghie |Edwin Elmhirst |Dexter Yan
China’s Biotech Stocks Proved More Resilient Than US Amid Market TurmoilStart-ups from China dominated the fastest-growing share prices for mid-cap biopharma companies in Q1, while the biggest decliners were mainly US firms.
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1 week ago | 
insights.citeline.com | Dexter Yan
Henlius In David Versus Goliath Race With Pfizer For First PD-L1 ADC While Henlius Biotech’s PD-L1-targeting antibody-drug conjugate HLX43 is struggling to catch up with Pfizer’s PF-08046054, the global frontrunner in the space, a key differentiation of the China-originated asset could lie in PD-L1-negative patients. Henlius’ HLX43 is the second most advanced in the class of PD-L1-targeting ADCs globally, after Pfizer's PDL1V. (Shutterstock)
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2 weeks ago | 
insights.citeline.com | Dexter Yan
Will China’s Retaliatory Tariffs Galvanize Manufacturing Onshoring? Some Firms Are Already Localizing China’s imposed large retaliatory tariffs on US pharmaceuticals on 10 April, but some domestic firms with in-licensed, US-origin assets were already moving to localized manufacturing. China ran a deficit of $3bn in the drug trade with the US in 2024. (Shutterstock)
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2 weeks ago | 
insights.citeline.com | Dexter Yan
New Data Strengthen Case For RemeGen’s Telitacicept In gMG‘Highest’ MG-ADL Response RateResults from a China Phase III trial show the potential of RemeGen's fusion protein telitacicept in generalized myasthenia gravis. But study design differences make direct comparisons with argenx's FcRn inhibitor Vyvgart challenging. RemeGen has shown telitacicept's potenial as a an alternative to FcRn Inhibitors In gMG. • Source: Shutterstock
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3 weeks ago | 
insights.citeline.com | Dexter Yan
AZ’s Oncology R&D Head On China’s Scientific Promise And True InnovationUK Major Committed To R&D Presence, AlliancesAstraZeneca remains committed to investing in R&D and alliances in China, where Susan Galbraith, the UK major’s head of oncology R&D, sees innovation eventually reaching parity with the US and Europe. AstraZeneca’s 14 years of deal-making in China could be traced to true innovations. (Shutterstock)
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3 weeks ago | 
insights.citeline.com | Dexter Yan
Hengrui Renews Global Phase III Push As China Players Plan Pivotal Multinational TrialsAfter a more than three-year hiatus, China's Hengrui has signalled its return to multiregional Phase III trials as it looks to globalize its innovative pipeline. Meanwhile, a number of other Chinese players have announced plans to kick off Phase III trials this year and beyond. Hengrui is making a comeback to the stage of global Phase III clinical studies. (Shutterstock)
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4 weeks ago | 
insights.citeline.com | Dexter Yan
RemeGen Fast-Tracks Potential World-First BLys/APRIL Agent For gMG In Global Phase III TrialRemeGen is planning to complete enrolment in the global Phase III RemeMG study with telitacicept in generalized myasthenia gravis by the end of 2025 or early 2026. The Chinese firm has already sidelined two other global Phase III trials with the molecule to prioritize the indication.
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1 month ago | 
insights.citeline.com | Dexter Yan
Elevar/Hengrui’s Second US CRL A Bad Omen For Multiregional Trials In Asia-Dominant Cancers? While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year. An equal allocation of study populations in multiregional trials is set to become a major hurdle for sponsors. (Shutterstock)
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1 month ago | 
insights.citeline.com | Dexter Yan
Kelun Wins World’s First TROP2 ADC Approval In Lung Cancer, Merck Left OutWhile diverging from partner Merck & Co. in its study dosage of sacituzumab tirumotecan, Kelun has garnered the world’s first approval, in China, for a TROP2-targeting antibody-drug conjugate, for the treatment of lung cancer. Merck/Kelun and AstraZeneca/Daiichi Sankyo are locked in a race to win lung cancer labels for their TROP2 ADCs. (Shutterstock)
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1 month ago | 
insights.citeline.com | Dexter Yan
TYK’s EGFR Inhibitor Bests Tagrisso In NSCLC Brain Metastases Top-Line iORR Findings ReleasedChinese biotech TYK Medicines says its EGFR inhibitor outperformed AstraZeneca’s same-class blockbuster Tagrisso in a pivotal Phase II trial for first-line use in brain metastases resulting from EGFR mutation-positive non-small cell lung cancer. TYK Medicines is developing a novel EGFR inibitor for certain non-small cell lung cancer patients with brain metastases. (Shutterstock)
