Asian Biotechies Walk Into A Bar


A Newsletter from InScienceWeTrust Community & BioAdvisory


Issue_004, 2023-07-09 [updated]

SAPA hosted their flagship SAPA Healthcare Forum & Roadshow in New York City on July 8th, 2023. This was the first in-person meeting of this multi-year conference since the COVID pandemic, and the vibe and energy were simply contagious, in a good way.


Stifel Healthcare team released their data-packed 1H2023 healthcare capital market review on July 7th (Stifel Investment Bank subscribers only). They depicted a sobering yet highly optimistic outlook. We were intrigued by two strong tailwinds:

  • In addition to ~$93 billions worth of M&A announced in 1H2023, the top 20 pharma still have $655 billion comfortable and ~$1.3 trillion stretched firepower for M&A. Big pharma's balance sheets are extremely strong and the current M&A and BD frenzy would likely continue for a few years.
  • 1H2023 was the first year when China's out-bound deals outnumbered in-bound deals, and, more strikingly, the ratio of cash earned from out-bound deals to cash spent on in-bound deals reached jaw-dropping 34.9x, compared with 2.8x in 2022. This observation validates our view that China biotech is an essential innovation source to global biopharma and has become a net innovation exporter.


Additionally, we also observed the landmark full approval of Eisai/Biogen's Leqembi for Alzheimer's Disease, a surprising speed bump on the seemingly unstoppable dash of AstraZeneca/Daiichi Sankyo's TROP2 ADC, a likely one-trillion capital injection to China business from Middle East countries' sovereign wealth funds, and more.

2023 SAPA Healthcare Investment Forum & Roadshow


On July 8th, 2023, SAPA successfully hosted the first in-person meeting of their flagship Healthcare Investment Forum & Roadshow conference in Columbia University in New York City, and you can check the meeting report here.


One highlight of this conference is the the star-struck Entrepreneurship Workshop given by experienced biotech CEO, biotech investor, CPA, tax expert, cross-border transaction lawyer, IP lawyer, and serial entrepreneur. Asked to share their painful yet meaningful setbacks during the panel discussion, every panelist provided extremely educational stories that inspired a packed room of existing and aspiring entrepreneurs.

Leqembi's full FDA approval label has a black-box

On July 6th, the U.S. FDA granted full approval of Eisai and Biogen's Leqembi for the treatment of Alzheimer’s disease. Leqembi is the first therapy clearly proven to slow down the cognitive and functional decline associated with the disease.


Leqembi is a monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid beta. Leqembi received accelerated approval on January 6 this year based on its ability to reduce brain amyloid plaque, a surrogate endpoint deemed by the agency to be reasonably likely to predict a clinical benefit. Leqembi’s full approval was supported by results from the large Ph3 CLARITY-AD trial showing that it slowed the rate of cognitive and functional decline by 27% compared to a placebo in patients with early Alzheimer’s disease after 18 months of treatment. The full approval came a month after the FDA’s Advisory Committee agreed unanimously that CLARITY-AD verified the drug’s clinical benefit.


The drug’s label states that treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of the disease, consistent with the population studied in clinical trials. Some estimates that there are approximately 1 million such patients in the U.S., out of 6.5 million who are currently living with Alzheimer’s disease. The drug’s label also includes a black-box warning about the risk of amyloid-related imaging abnormalities (ARIA), which causes swelling or bleeding in the brain and can be fatal in rare cases. FDA recommends prescribers to test for ApoE ε4 status, because patients who are homozygous for ApoE ε4 (approximately 15% of Alzheimer’s disease patients) are at an increased risk of developing ARIA when treated with anti-amyloid beta antibodies. The agency also urges doctors to take additional caution when considering prescribing to patients who take anticoagulants due to the increased risk of intracerebral hemorrhage.


Despite the new label language, doctors were already familiar with the ARIA problem and were already planning to treat patients accordingly anyway, analysts at Leerink Partners (previously SVB Securities) said in a note.

   

Since its accelerated approval in January, Leqembi has been largely unavailable to patients with Alzheimer’s disease due to the restrictive Medicare policy; however, with the traditional approval, CMS has confirmed that broader coverage is now available under the Medicare program, provided that patient is at the early Alzheimer’s disease stage with documented evidence of amyloid plaque in the brain and that the physician participates in a qualifying registry. The list price of Leqembi is $26,500 annually.


(contributed by Kate Gao and Angus Liu)

Global Biotech News


2023-07-07 A WSJ article suggests a trillion-dollar opportunity to China business from Middle East. China's increasing clout in Middle East are paying off as many China companies are getting substantial capital from Middle East's biggest sovereign-wealth funds. However, the slice for China biotech company seems very small. One way to get a larger slice would be for the China biotech companies to bring jobs to Middle East, based on an investor who just visited Middle East recently.


2023-07-06 Stifel Healthcare team published 1H2023 Market Review. This 100+ pages report provides torrents of data to depict the current capital market of healthcare, which feels sobering for now but highly optimistic in the future.


One highlight to cheer the stressed biotech up: in addition to $93 billion worth of M&A deals that have been announced in 1H2023, the top 20 pharma companies may still have $655 billion of comfortable or ~$1.3 trillion stretched M&A firepower for M&A, an extraordinary strong balance sheet!


2023-07-06 GSK's ViiV Healthcare is considering using an external control to study long-acting HIV drug Cabenuva in patients who aren't virologically suppressed by daily oral meds because of adherence challenges, Fierce Pharma reports. The FDA has in the past granted several approvals based on external controls, mostly in rare diseases. In this case, ViiV's R&D chief Dr. Kimberly Smith argued that randomizing patients who are known to have adherence issues to oral drugs doesn’t make sense and could be dangerous. (contributed by Angus Liu)


2023-07-06 The clear leading position of Eli Lilly in obesity and diabetes lifts their stock to a whopping ~45x PE (price-to-earning ratio), higher than the PEs of Microsoft, Apple, and Google. STAT News published a behind-the-scenes business story that features David Ricks, CEO and Daniel Skovronsky, CSO of Eli Lilly.


2023-07-05 Moderna strikes a deal worth up to $1 billion to develop, produce mRNA drugs in China, reported by Fierce Pharma. An interesting twist of this deal is that "any medicines produced under this agreement will be exclusively for the Chinese people" according to Moderna's statement.


2023-07-03 Blue View (深蓝观), a leading healthcare newspaper in China, published an interesting commentary titled “跨国药企在华的新玩法” to review 20+ years' history of how MNCs have been continuously evolving in response to the ever-changing market and geopolitical conditions in China. This article includes some views from our own Leon Tang.


2023-07-03 AstraZeneca and Daiichi Sankyo shares fall after lung cancer drug underwhelms in trial. Although TROP-2 ADC datopotamab deruxtecan phase 3 TROPION-Lung01 trial met PFS endpoint, it has not met the co-primary endpoint of overall survival. What really spooked investor was some reported deaths, to which the company did not provide more details. Once believed to be a clear best-in-class drug in the TROP-2 ADC space, these preliminary data cast some doubt.


2023-06-29 BioMarin recently completed a yearslong marathon to win FDA approval for hemophilia A gene therapy Roctavian. Analysts expect that the therapy can eventually reach blockbuster status, but a team at Leerink Partners predicted a slow sales ramp initially, Fierce Pharma reports. Unlike previous gene therapy approvals, hemophilia A has many other effective treatments. Patients on Roche's Hemlibra are less likely to switch, a recent Leerink survey of 18 U.S. doctors found. Still, the polled doctors generally like Roctavian's efficacy data, including its durability. (contributed by Angus Liu)

Drink & Barbecue in July!


Building quality personal relationships among our members is a major goal of our community, and nothing is better than a meet-up over refreshing drinks and tasty barbecue.


We cordially invite you to our first in-person meeting in Jersey City, NJ in this July. Please take the survey to help us prepare this event.

Edited by Leon Tang, Angus Liu, and Kate Gao

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