4 products have entered the clinic Eisai still decided to close H3 Biomedicine

In recent years, cancer has become the "number one killer" of human health, and the demand for medication is expanding
.

But the field of oncology is also the most competitive field in the future, and the speed of drug update iteration may exceed the perception
of many people.

Eisai announced its resolution to restructure its global structure from its previous business group structure to a new R&B, Deep Human Biology Learning
.

A few days later, Eisai decided to permanently shut down its oncology department, H3 Biomedicine, with an estimated layoff of 88, 79 of whom will be laid off
by September 15.

4 products have entered the clinic

Eisai still decided to shut down H3 Biomedicine

Founded in 2010, H3 Biomedicine focuses on discovering and developing precision cancer treatments using its integrated data science, human biology and precision chemistry discovery engine
.

At present, 4 products have entered the clinical development stage
.

H3 Biomedicine product line

Source: H3 Biomedicine

Last August, H3 also hired Ross Pettit, former senior vice president of global development operations at BeiGene, as vice president of
business operations.

On July 15, 2022, Eisai announced a new organizational structure, DHBL (Deep Human Biology Learning), which is scheduled to be launched
on October 1, 2022.
Previously, the Neurology Group, Oncology Group, Drug Development Center, and HC Data Creation Center will be dissolved
.
The closure of H3 Biomedicine is part of
that huge plan.

Eisai explained that under the discovery and development of new DHBL drugs, diseases will be regarded as disease continuums, and genetic information, pathophysiological information and clinical information related to the root causes of diseases will be comprehensively analyzed
.
Eisai will use AI and other technologies to discover next-generation drugs
more efficiently and innovatively through deeper human biological learning, information based on patients' biomarkers and medical images.

On the other hand, Eisai said that Alzheimer's disease and related brain disease modification therapy (DMT) related research and development, supervision, medical treatment, value, access, marketing and alliance management functions, of which the next generation of Alzheimer's disease treatment drug lecanemab, is its most important project
.

Bet on the field of neurological diseases

Can Eisai turn over?

Eisai Pharmaceutical, headquartered in Tokyo, Japan, is one of
Japan's top five pharmaceutical giants.

As early as 1996, Eisai launched the classic treatment drug of Alzheimer's disease Doneprazine hydrochloride, and joined hands with the two giants of Pfizer and Johnson & Johnson to make the drug an "explosive product"
.
For decades thereafter, Eisai has been betting heavily on CNS drug development
.

According to its fiscal 2021 annual report, two of its four highest-selling major products belong to the field of neurological diseases – Fycompa and Dayvigo, with sales of 31.
9 billion yen (about 1.
57 billion yuan) and 16.
4 billion yen (about 809 million yuan)
respectively.

Eisai commercialized and marketed products

Source: Eisai

More than twenty years after the introduction of donepezi, Eisai launched Aduhelm last year to treat early-stage Alzheimer's disease
.
However, this time Eisai was not so lucky, and Aduhelm's approval was controversial and did not achieve the expected sales
.

However, the Aduhelm storm did not affect the research and development
of Lecanemab, another Alzheimer's disease therapy cooperated by Bojian and Eisei.

A few days ago, Eisai and Bo Jian announced that the US FDA has granted them the Lecanemab priority review qualification for the in-research treatment of Alzheimer's disease, and the PDUFA date is January 6, 2023
.
The drug was recognized as a breakthrough therapy by the FDA in June last year and was highly anticipated
by Eisai.

Lecanemab, similar to Aduhelm's principle of action, is a humanized monoclonal antibody
for the treatment of Alzheimer's disease (AD).
Lecanemab selectively binds to neutralize and eliminate soluble, toxic Aβ aggregates (fibrinofibrils) that are thought to accelerate the neurological degeneration process
of AD.
Thus, lecanemab may have an effect on the pathologic mechanisms of the disease and delay disease progression
.

Lecanemab's biologics license application is based on Lecanemab's clinical, biomarker and safety data from the proof-of-concept Phase IIb clinical trial, the Open Label Extended Study, and the unblinded safety data
of ongoing Phase III clinical trials.
Data from phase IIb clinical trials showed that lecanemab reduced amyloid plaque levels in the
brain.
After 18 months of treatment, lecanemab (10 mg/kg every two weeks) reduced brain amyloid levels by an average of 0.
306 SUVr (baseline value of 1.
37).

More than 80% of the participants met the amyloid negative criteria
for visual evaluation of scans.
At the same time, the reduced levels of amyloid are associated with a slowdown in the clinical decline in multiple cognitive scores
.
In addition, the ongoing Phase III clinical treatment of early-stage AD is expected to have primary clinical endpoint data
available this fall.

In addition to lecanemab, Eisai also has a number of products in the field of neurological diseases that are also worth paying attention to
.

Lemborexant (Dayvigo) is a small molecule orexin receptor antagonist
independently developed by Eisai.
The results of two critical phase 3 studies (SUNRISE 2 and SUNRISE 1) in adult patients with insomnia showed a statistically significant advantage
in both subjective and objective evaluation compared with placebo.
As a result, Dayvigo was approved by the US FDA in 2019, becoming the first insomnia drug
to have 12 months of treatment safety data and 6 months of sleep and sleep maintenance efficacy data in key studies.

Fycompa (Piram Panayne) is a new type of anti-epileptic drug developed by Eisai and is a highly selective, non-competitive AMPA receptor antagonist
.
At present, pyrampanaj has been approved for marketing in more than 70 countries and regions, including Japan, the United States, China, and other countries in Europe and Asia, as an adjunct to
partial seizures (with or without secondary generalized seizures) in patients with epilepsy aged 12 years and older.
In addition, the globally approved indications for pirampanaj include adjuvant therapy for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older, monotherapy and adjunctive treatment of partial seizures (with or without secondary generalized seizures)
in patients with epilepsy 4 years and older.
Eisai is also conducting a phase III clinical study (Study 338) worldwide with the intention of using the drug to treat seizures
associated with Lennox-Gastaut syndrome.
In addition, the development of Eisai injection preparations is also underway
.

Lorcaserin (Belviq) is a selective serotonin serotonin 2C (5-HT2c) receptor agonist
.
Originally developed by the American pharmaceutical company Arena, it was approved by the FDA in 2012 for adult obese or overweight patients with a BMI ≥ 27kg/m2, and later Eisai signed an exclusive license agreement with Arena to obtain the commercialization rights
of Locaserin in most countries and regions around the world.
However, in 2020, the FDA asked for the discontinuation of lorcaserin, as clinical trials showed an increase in cancer incidence
.
At the same time, however, Lostoryrin has made progress
in treating chronic severe epilepsy (Dravet syndrome) in children.
A Phase 3 study of the indication for Dravet syndrome is currently underway and the FDA has granted it orphan drug qualification
for this indication.

Conclusion

In recent years, the emergence of new technologies such as immunotherapy has made great progress in anti-tumor treatment, and various new drugs have appeared in the field
.
However, the problems of high risk and fierce competition in the research and development of new anti-tumor drugs cannot be ignored
.

At this year's ASCO conference, Pfizer's world-first CDK4/6 inhibitor pipercille clinical data is not ideal, and it will be at a disadvantage when facing Novartis's Regislil and Lilly's
Abecilique in the future when competing globally.
The failure of Roche's TIGIT has cast a shadow over a
number of new drugs targeting TIGIT.
The Enhertu of the First Third Republic and AstraZeneca, because of the excellent clinical data, may profoundly affect the treatment of breast cancer, and at the same time may cause a very fatal blow
to the development of subsequent drugs and the drugs designed as "templates" of the previous generation of ADC drugs.

The oncology field has long been a competition in the Red Sea, with high risks and uncertain life cycles, and may not be the best choice
for "endogenous growth" companies.

For some areas that are slowly updated, such as the Alzheimer's Track, in recent years, in addition to Aduhelm of Eisai and the domestic nine phase one, new drugs that can count the names and are recognized by the market have basically disappeared
.
With its deep accumulation in the field of neurological diseases, Eisai may really be able to break the deadlock of new drugs for Alzheimer's disease and achieve new glory
.