Basil Lui (linkedin.com/in/basillui) and Ning discuss Moderna and Merck's personalised mRNA cancer vaccine intismeran autogene (mRNA-4157/V940) plus Keytruda, the first positive Phase 3 result for a personalised neoantigen therapy, published in the New England Journal of Medicine: two-year recurrence-free survival of 82.2% versus 70.0% after surgery for high-risk melanoma. The vaccine is not approved, and overall survival has not been shown. Also: BioNTech's US$205 million priority review voucher; Reuters reporting, citing six sources, that the FDA has shelved the commissioner's national priority voucher pilot, which the health department says is ongoing; and China's approval of Lilly's weight-loss pill orforglipron. Beyond the clinic: India's Temple wearable, sold as a wellness device, and how the US and Singapore draw the medical-device line.

Full transcript and all sources for this episode

Both voices are AI-cloned. Basil Lui is the real person behind the show; Ning is an AI co-host. Personal views, not investment or medical advice.

Chapters
0:00 Intro and AI-voice disclosure
0:47 A personalised mRNA cancer vaccine
2:05 Phase 3 results and what's next
3:19 How the vaccine is made
4:29 Bancel, Asia sites, Singapore
6:19 BioNTech's priority review voucher
7:21 FDA voucher pilot and orforglipron
8:14 Temple and two rulebooks
9:27 Apple, Whoop, peptides and HSA
10:41 What to watch and sign-off

Key sources: NEJM: intismeran autogene Phase 3 (INTerpath-001) · Moderna: recapping the Phase 3 INTerpath results (company recap) · BioNTech: priority review voucher (company statement) · Reuters: China approves Eli Lilly's weight-loss pill orforglipron

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Basil Lui (linkedin.com/in/basillui) and Ning discuss Abbisko's pimicotinib (Pimjetmi), FDA-approved for tenosynovial giant cell tumour after China, Canada and Switzerland, on a trial with almost half its patients in China; the FDA's Saturday date for Akeso and Summit's ivonescimab in EGFR-mutated lung cancer; Korea allowing GLP-1 drugs bought abroad; and Windward Bio's Nasdaq IPO built on antibodies from Kelun-Biotech, Harbour BioMed and Qyuns. ImvivaBio's off-the-shelf CAR-T CTA313 reports 12-month lupus data from Phase 1 work in China, and Shionogi licenses cefiderocol to Singapore-based Link Healthcare. Also: Neuralink's PRIME 2 adds stroke; a Chinese all-day EEG electrode; Korea's RayWatt.

Full transcript and all sources for this episode

Both voices are AI-cloned. Basil Lui is the real person behind the show; Ning is an AI co-host. Personal views, not investment or medical advice.

Chapters
0:00 Intro and AI-voice disclosure
0:51 Abbisko's pimicotinib, China then US
3:30 Akeso and Summit's ivonescimab date
4:54 Korea lets in GLP-1 drugs bought abroad
6:06 Windward Bio's IPO, Chinese antibodies
7:28 CTA313: off-the-shelf CAR-T for lupus
8:54 Shionogi's cefiderocol and Singapore
9:51 Neuralink's PRIME 2 adds stroke
11:10 Beyond biotech: EEG gel and RayWatt
12:37 What to watch and sign-off

Key sources: US FDA: pimicotinib approval · Summit Q3 2026 (company release) · ImvivaBio: CTA313 at ACR (company press release) · Shionogi: cefiderocol licence (company press release)

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Basil Lui (linkedin.com/in/basillui) and Ning discuss Charles River, Tigermed and Frontage's chairman taking Hong Kong-listed Frontage private and selling its Pennsylvania testing labs to Charles River; a US-approved RAS inhibitor, daraxonrasib, that Chinese trade reports say is proposed for priority review in China; and Hengrui's oral Lp(a) pill, whose rights outside Greater China sit with Merck. Bayer's asundexian, a factor XIa blood thinner, was approved in China first and then by the FDA. Mirum reports a second Phase 3 win in hepatitis delta, and Beam says its base-edited sickle-cell therapy met its pivotal mark. Beyond biotech: Oura agrees to buy Counsel Health, and Japan's BionicM raises the first close of a Series B for a motorised prosthetic knee.

Full transcript and all sources for this episode

Both voices are AI-cloned. Basil Lui is the real person behind the show; Ning is an AI co-host. Personal views, not investment or medical advice.

Chapters
0:00 Intro and AI-voice disclosure
1:01 Frontage's take-private and the US labs
3:01 BeOne's RAS pill, proposed for priority review
4:27 Hengrui's oral Lp(a) pill, and Merck
5:19 XtalPi, Pierre Fabre, and Shengnuo
6:26 Bayer's asundexian, approved in China first
7:51 Hepatitis delta, and a base-edited sickle-cell therapy
9:29 Beyond biotech: Oura, Counsel Health, and BionicM
10:24 What to watch and sign-off

Key sources: Charles River (company press release) · FDA: daraxonrasib (Rasonque) · FDA: Sunharbo (asundexian) · Mirum: AZURE-4 (company press release) · Beam: BEACON (company press release) · Oura: Counsel Health acquisition

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