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Focus On Asia

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ASCO: Simcere Targets Suvemcitug OS Win In Platinum-Resistant Ovarian Cancer

In a late-breaker oral presentation at ASCO on the SCORES study with suvemcitug, Simcere revealed a trend favoring an overall survival advantage in platinum-resistant oral cancer, despite immature data.

ASCO China

New Promise, Looming Competition For DMD In China

With several new drugs progressing for the estimated 70,000 patients in China with DMD, a recent setback for Nippon Shinyaku's contender and progress for Chinese gene therapy developers are adding both uncertainty and likely competition in an untapped market with pressing medical need.

China Clinical Trials

Stake Sale Speculation At Two PE-Controlled Firms In India: Will Valuations Fly?

Two top-50 Indian firms are speculated to be on the block with valuations expected to be richer than past multiples paid by buyers. A small, less known life sciences solutions provider is also keen to rope in a CDMO partner. Scrip speaks to a cross-section of experts on the action in deal street.

Commercial M & A

Bukwang Adds To Stacking Mid-Stage Failures In Parkinson's

Bukwang and subsidiary Contera have become the latest to fail to progress a novel Parkinson's therapy to late-stage trials after a Phase II miss, although several other Korean firms remain in the race for the challenging indication, albeit mainly in Phase I-II.

South Korea Clinical Trials

ASCO: Ivonescimab A New Challenger To Keytruda In 1L, PD-L1-High NSCLC?

Backed by strong progression-free survival results from the China-only, head-to-head HARMONi-2 trial, Akeso/Summit’s ivonescimab could be set to become a global contender against established standard of care Keytruda in first-line, PD-L1-high non-small cell lung cancer.

China Clinical Trials

China Biotech Podcast: Going Global Trends, Rare Disease Drug Development

Guest speaker Professor Guangzuo Luo joins Brian Yang and Dexter Yang to discuss orphan drug development and going global trends for Chinese bioventures, along with the latest business moves from Shanghai Fosun and Jiangsu Hengrui.

China Business Strategies

Biopharma Leaders Talk Radical Steps, Regulatory Reform, Open AI To Spur India R&D

Biopharma experts including Nobel Laureate Professor Jack Szostak share their views on emerging innovation ecosystems and how India can get it right as it seeks to shift gears in R&D. Panelists noted that VC investments can be a mixed bag, called for regulatory vision that ensures safety alongside accelerated pathways like the LPAD in the US and also ‘open” AI platforms.

Research & Development Regulatory

ASCO: GenFleet’s KRAS G12C/EGFR Combo Sets Sail In First-Line NSCLC

Excluding PD-1 inhibitors in its combination strategy for oncology, preliminary results from GenFleet’s Phase II KROCUS study presented at ASCO demonstrate promising efficacy for fulzerasib plus cetuximab in the first-line treatment of KRAS G12C-mutated, advanced non-small cell lung cancer.

China ASCO

Amid Talk Of KKR Stake Sale, JB CEO Stresses Business As Usual

In an interview with JB CEO Nikhil Chopra, Scrip discusses talk of a stake sale by private equity fund KKR, gains from acquisitions including select Novartis brands, plans to ascend to the top five in cardiology and a ramp up of the CDMO business, which has clients including J&J.

Commercial Business Strategies

Lights, Camera, Goal Dates: Pharma Gets Going With ANDA Suitability Petitions

Sponsors return with US suitability petition submissions against the backdrop of GDUFA III new goals for the FDA's response to such petitions. Scrip tracks some of the activity as applicants seek to tap market opportunities without the need for new clinical data.

United States Regulatory

China Rare Disease Firms Aspire To Global Stage

Chinese developers of innovative drugs for rare diseases are hoping to step into the global spotlight, helped by rapid clinical progress and low costs on their home turf.

China Clinical Trials

Korea Looks To Close Gap In AI Drug Development Capabilities

Syntekabio CSO HeaKyoung Cho talks to Scrip how the AI-driven drug development situation in Korea compares with global trends and what the domestic industry needs to do to survive rising competition at home and abroad.

South Korea Interviews

Glenmark Initiates US Plant Cutback, Pins Hopes On gFlovent, Other Filings

Glenmark impairs oral solid dosage and nebulizer blocks at US manufacturing site amid tough market conditions. Can the firm's thrust on injectables and new respiratory filings including for generic Flovent, alongside leadership change, lift the US business?

Commercial Compliance

China Approval For Akeso’s Bispecific But ASCO Data Unnerve Investors

Ivonescimab in combination with chemotherapy reduced the risk of disease progression or death by 54% versus placebo in EGFR-mutated, non-squamous NSCLC after failed EGFR inhibitor treatment. However, the progression-free survival data did little to satisfy investors’ demand for clear benefits versus competitors. 

China Approvals

China Biotech CEO Interview: Starting A CNS Venture In An Economic Downturn

From Wyeth/Pfizer to Jiangsu Hengrui to IMab to starting her own biotech, Joan Huaqiong Shen has seen many ups and downs of drug development in China. She sat down with Scrip on the sidelines of the recent DIA China meeting to discuss her latest startup devoted to novel small molecules to treat schizophrenia and epilepsy and a gene therapy for ALS.

China Research & Development

AstraZeneca Advancing Respiratory Aspirations In China

The company is adopting a two-pronged strategy to capitalize on its presence in the country to expand the market for its inhaled therapies and biologics for asthma and COPD.

China Respiratory
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