Weekly intelligence on China biotech deals, CDE filings, and BIOSECURE compliance.
16 issues published · Every Thursday since December 2025
Showing 9 briefings tagged “CDE Filing”
Antibody-drug conjugates dominate China's out-licensing pipeline. We analyze why Chinese companies have built durable advantages in ADC development, break down the Merck-Kelun platform deal, and track this week's CDE filings in the bispecific-ADC space.
The OMB has 9 months to publish the BCC list. We break down the three designation categories, track which companies face real exposure, and analyze what AstraZeneca's $18.5B CSPC deal structure tells us about pricing China risk in 2026.
Early 2026 deal data confirms the acceleration: average deal sizes are tracking 76% larger than 2025, with average values reaching $1.3 billion. We analyze the structural drivers, track the BIOSECURE BCC list countdown (9 months to go), and preview the spring conference season.
AstraZeneca's $18.5B CSPC deal wasn't just a cardiovascular play — it signaled Big Pharma's recognition that Chinese small molecule innovation extends to metabolic disease. We map the emerging Chinese GLP-1 landscape and analyze what it means for the global obesity drug race.
12 public biotech companies have now added BIOSECURE risk factor language to SEC filings. We analyze the emerging standard disclosure template, track the Pentagon 1260H list aftermath, and cover this week's CDE filings.
A new deal structure is emerging: Chinese biotechs creating Western-capitalized NewCos to develop their assets ex-China, instead of traditional out-licensing. We analyze the model, track the first examples, and explain why this changes the competitive dynamics for BD teams.
The FDA has accepted Summit Therapeutics' BLA for ivonescimab with a PDUFA target action date of November 14, 2026. We analyze what this means for the bispecific competitive landscape and track the latest BIOSECURE SEC disclosure wave.
Takeda paid $1.2 billion upfront to Innovent Biologics for rights to IBI363 and IBI343 — the largest upfront payment ever for Chinese-developed antibody assets. We analyze the deal structure, the competitive implications, and what this signals for 2026 BD strategy.
Summit Therapeutics submitted a BLA to the FDA for Akeso's ivonescimab (PD-1/VEGF bispecific) in EGFR-mutant NSCLC. If approved, it would be the first China-originated bispecific antibody to reach the US market — and a validation of the entire China-to-West licensing model.
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