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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Basil Lui (linkedin.com/in/basillui) and Ning discuss the US Defense Department's removal of WuXi AppTec from its 1260H list and what it does not settle, two Chinese antibody–drug conjugates in EGFR-mutated lung cancer from Biokin and Hengrui, and Vir's hepatitis delta result with the China angle through Brii Biosciences. Beyond biotech: Singapore's SG-INSIGHT genome sequencing, a two-step chemogenetic approach to drug-resistant epilepsy from Beijing, and a new FDA eye-risk warning for GLP-1 drugs.

Full transcript and all sources for this episode

Our voices are AI-cloned from our own. Personal views, not investment advice. Neither Basil nor Ning holds investments in any company mentioned.

Chapters
0:00 Intro and AI-voice disclosure
0:54 WuXi AppTec and the Pentagon list
2:33 Two Chinese ADCs in EGFR lung cancer
5:33 Hepatitis: Vir and Brii's shared drug
7:16 Beyond: Singapore's SG-INSIGHT genomes
8:19 Beyond: a chemogenetic switch for epilepsy
9:23 Beyond: FDA GLP-1 eye warning
10:06 What to watch and sign-off

Key sources: Federal Register: WuXi AppTec 1260H removal · BMS: PANKU-Lung01 (company press release) · ASCO Post: HERON-Lung01 · Vir: ECLIPSE 1 (company press release) · FDA: GLP-1 NAION safety communication (all sources on the episode page)

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Akeso’s ivonescimab, Genrix’s early lupus data and Ebola vaccine candidates: evidence, money and delivery across this week’s East–West biotech news. China review is not approval; early uncontrolled lupus responses are not comparative benefit.

Full transcript and all sources for this episode

Basil and Ning use AI-cloned versions of their own voices. Personal views, not investment or medical advice. Basil reports no holdings in companies mentioned.

Research cut: 9 Nov 2026, 05:55:43 SGT. Weekly retrospective: 2–8 Nov.

0:00 Introduction and AI-voice disclosure
1:15 Akeso: evidence versus review
5:16 Hemay and deal payment structures
9:32 iX: licences and the next document
10:45 Ebola: trial evidence and delivery
13:41 BionicM, Mindtrix and egg proteins
19:40 Genrix: early lupus evidence
21:13 The next evidence to watch

Key sources: Akeso: China priority review, 5 Nov; WHO: Tumaini candidates, 4 Nov; China lupus trial registry; Cullinan: interim China lupus data, 8 Nov. Sponsor-reported interim lupus data and all original sources are linked in the transcript.

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Which uncertainty did an announcement actually remove—and what evidence should come next?

Basil Lui and Ning discuss Akeso's ivonescimab priority review in China, new HORIZON and ZEUS cardiovascular trial details, and earlier Asian research on Kylo-11 and tocilizumab. Plus Allist and Zhifei development steps, AstraZeneca's China infrastructure, vascular devices and Asian egg-bioreactor services.

Full transcript and all sources for this episode

Our voices are AI-cloned from our own. Personal views, not investment advice. Neither Basil nor Ning holds investments in any company mentioned.

Chapters
0:00 Intro and AI-voice disclosure
1:00 Akeso: review versus approval
3:06 China: trial steps and infrastructure
4:41 HORIZON, ZEUS and Eastern context
7:29 Beyond: vascular-device investment
9:07 Beyond: egg-bioreactor tools
11:28 What to watch and Monday sign-off

Key sources: Akeso: priority review · AHA: HORIZON · AHA: ZEUS (all sources on the episode page)

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Today on The East-West Bio Brief daily, Basil Lui and Ning cover China's approval of Bayer's asundexian (Sunharbo), the world's first Factor XIa inhibitor for stroke risk reduction; Qyuns Therapeutics licensing a preclinical TL1A/IL-17 antibody to Caldera for US$30M upfront; Hinova licensing its oral VAV1 molecular glue to Evommune for US$30M upfront; and InnoCare's Phase 3 of orelabrutinib in chronic ITP. Plus Cloudbreak's CBT-001 pterygium Phase 3, Proteina's AI biofoundry raise in Korea, ANI's bid for Sweden's Egetis, Tianjin University's non-invasive BCI study, device-maker cost pressure at Mindray and United Imaging, and the market mood.

Full transcript and all sources for this episode

As always, these are our own voices, AI-cloned so we can bring you this every morning, Tuesday to Sunday. Personal views, not investment advice. Basil holds no positions in any company mentioned.

Chapters
0:00 Intro and AI-voice disclosure
0:48 Bayer Sunharbo FXIa China approval
2:18 Qyuns–Caldera and Hinova–Evommune
4:16 InnoCare orelabrutinib ITP Phase 3
5:24 Cloudbreak CBT-001 pterygium Ph3
6:17 Proteina AI biofoundry raise
6:50 ANI bid for Egetis
7:21 Tianjin BCI and device costs
8:30 Market mood and one thing to watch

Key sources: Bayer: asundexian / Sunharbo China approval · Qyuns–Caldera HKEX announcement · Evommune–Hinova (Fierce Biotech) · InnoCare orelabrutinib ITP Phase 3 (all sources on the episode page)

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Tell us what you want us to read next, or what we got wrong, in the comments on the weekly LinkedIn newsletter.

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