BioCentury This Week

Rising first-in-class innovation, faster IND reviews and deep patient pools are drawing global biotechs to China, even as U.S. outbound investment restrictions loom. In a special edition of the BioCentury This Week podcast recorded live at the 13th BioCentury-BayHelix China Healthcare Summit in Shanghai, BioCentury’s Jeff Cranmer, Simone Fishburn and Josh Berlin are joined by Kali Therapeutics CEO Weihao Xu, Charles River’s Matthew Hewitt and Aerska CEO Jack O’Meara to discuss key themes from the event.
The panel assesses what the COINS Act could mean for U.S. investment in China biotech and how investors may adapt, how China’s 30-day IND review and new investigator-initiated trial rules are reshaping clinical strategy, and what dealmaking reveals about the country’s growing first-in-class pipeline. They also preview BioCentury’s East-West Summit in Seoul, March 15-17.

View full story: https://www.biocentury.com/article/661483

#ChinaBiotech #COINSAct #ClinicalTrials #FirstInClass #BiotechPartnering

0:00 Live from China Healthcare Summit
5:20 China's Role in Biotech R&D
9:06 What COINS Could Mean for U.S. Investors
11:37 Faster IND Reviews and New IIT Rules
17:27 First-Order Innovation in China

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A BioCentury analysis of ESMO first-in-human abstracts finds antibody-drug conjugates outnumbering every other modality, even as payload innovation lags behind target innovation. On the latest BioCentury This Week podcast, BioCentury's analysts discuss why new targets alone may not be enough to overcome resistance.
Turning to policy, the analysts examine Representative Jake Auchincloss’ Faster Clinical Trials Act, which would embed trials in routine care and expand the NIH's All of Us biobank. They also discuss how U.S. investors are reacting to Treasury's proposed COINS Act rule, including a workaround that pays Chinese licensors on exit instead of with equity, and former FDA Commissioner Janet Woodcock's proposals to make individualized rare disease therapies commercially viable.

View full story: https://www.biocentury.com/article/661405

#ADCs #ClinicalTrials #BiotechPolicy #ChinaBiotech #RareDisease

0:00 Introduction
1:34 ESMO First-in-Human Analysis
10:26 Faster Clinical Trials Act
19:27 COINS Act and NewCos
28:19 Woodcock's Rare Disease Proposals
31:53 Biotech IPO Debuts

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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Proposed U.S. Treasury rules implementing the COINS Act would bar U.S. equity investments, joint ventures and co-development deals with China biotechs, potentially ensnaring Asia-to-West NewCos while leaving licensing intact. On the latest BioCentury This Week podcast, BioCentury’s analysts assess the rule’s implications for cross-border dealmaking, the competitive opening it may create for European companies, and China’s narrower-than-feared draft export controls on platform technologies.
The analysts also discuss what drew Gilead to pay $1.3 billion up front for stealth Shanghai biotech PepStar’s oral IL-23 peptide, and whether Merck and Moderna’s Phase III melanoma vaccine data clear the bar for adoption.

View full story: https://www.biocentury.com/article/661319

#BiotechPolicy #ChinaBiotech #CrossBorderDeals #NewCos #CancerVaccines

00:00 Introduction
01:31 Treasury's COINS Act Proposal
05:15 NewCos Under COINS
13:20 China's Draft Export Controls
18:39 Pepstar's Gilead Deal
23:24 Merck-Moderna Melanoma Vaccine

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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Roche’s $15 billion biobucks deal with Hansoh for preclinical ADCs is the latest in a string of China licensing deals carrying unusually large upfronts for early-stage assets. On the latest BioCentury This Week podcast, BioCentury’s analysts assess trends to watch ahead of Shanghai Life Sciences Week, including how new rules have curtailed China’s IIT pathway and a proposed export-control regime that could complicate cell and gene therapy and siRNA deals.
The analysts also discuss Merck KGaA’s $1.3 billion takeout of Silence, Arrowhead’s brain-shuttle tau data and the dose dilemma facing tau-lowering therapies, and whether a preclinical biotech like Isomorphic Labs can justify a $40-50 billion valuation.

View full story: https://www.biocentury.com/article/661224

#ChinaBiotech #siRNA #BiotechMA #DrugDiscovery #DrugDevelopment

0:00 Introduction
1:13 China Trends
9:00 Roche-Hansoh Deal
13:11 Merck KGaA Buys Silence
15:38 Arrowhead's Brain Shuttle
23:40 Isomorphic Labs Valuation

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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An M&A-fueled first half gave way to third-quarter underperformance for biotech as a short squeeze in Moderna forced specialist funds into selling some quality names and follow-on activity slowed. On the latest BioCentury This Week podcast, BioCentury’s analysts preview the fourth quarter, where rising bond yields and the U.S. midterms could keep financing and deal activity quiet through year-end.
The analysts also discuss why late-stage misses in Lp(a), IL-6, and Factor XI are pushing developers to rethink secondary prevention trial design, and PhRMA’s lawsuit to block CMS’s Globe Part B model, which could determine whether future administrations can impose international reference pricing without Congress.

View full story: https://www.biocentury.com/article/661134

#BiotechMarkets #DrugPricing #CardiovascularDisease #ClinicalTrials #FDA
 
0:00 Introduction
1:10 Biotech Market Outlook
11:40 CV Trial Design Rethink
18:24 PhRMA vs. GLOBE

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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