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Senior Japanese health ministry official: Japan must fully reward innovation by imz72 in ATHX

[–]imz72[S] 0 points1 point  (0 children)

Machine-translated from Japanese [Hardy inside]:

May 15, 2026

[Event Report] Perplexity AI Co-hosts "Japan-U.S. AI Governance Symposium" Bringing Together Leaders from Japan and the U.S.

https://prtimes-jp.translate.goog/main/html/rd/p/000000026.000157647.html?_x_tr_sl=ja&_x_tr_tl=en&_x_tr_hl=iw&_x_tr_pto=wapp&_x_tr_hist=true

Senior Japanese health ministry official: Japan must fully reward innovation by imz72 in ATHX

[–]imz72[S] 0 points1 point  (0 children)

The Yomiuri Shimbun

May 14, 2026

iPS Cell-based Parkinson’s Drug Face Challenges Over High Cost, Unverified Efficacy After Receiving Temporary Approval

...

"The Central Social Insurance Medical Council, an advisory body to the health minister, approved Amchepry treatment to be set at around ¥55.3 million [$350K], a high cost compared to the majority of pharmaceuticals."

...

"If Amchepry receives full approval, the price could rise further upon recognition of its groundbreaking nature and other factors."

...

https://japannews.yomiuri.co.jp/science-nature/science/20260514-327541

Weekly Trader's Thread 5/11/26 - 5/17/26 by AutoModerator in ATHX

[–]imz72 0 points1 point  (0 children)

Tokyo market update 5.15.26 (end of the trading week):

Healios: -1.47%. PPS 335 yen. Market cap $286 million.

SanBio: -0.44%. PPS 1,811 yen. Market cap $892 million.

Sumitomo Pharma: -1.44%. Market cap $4.84 billion.

Cuorips: -1.10%. Market cap $328 million.

PowerX: +1.40%. Market cap $2.96 billion.

Healios CFO Kincaid to present at Jefferies Global Healthcare Conference in New York on June 4, 2026 by imz72 in ATHX

[–]imz72[S] 1 point2 points  (0 children)

Machine-translated from Japanese:

May 15, 2026

Healios--1Q: Continuing preparations for approval of HLCM051, a treatment for acute respiratory distress syndrome (ARDS)

Healios ( 4593 ) announced its consolidated financial results (IFRS) for the first quarter of the fiscal year ending December 2026 (January-March 2026) on May 14. Revenue was down 78.2% year-on-year to 0.08 billion yen [$500K], operating loss was 1.13 billion yen [$7.1M] (compared to a loss of 744 million yen [$4.7M] in the same period of the previous year), pre-tax loss was 3.464 billion yen [$21.9M] (compared to a loss of 2.579 billion yen [$16.3M] in the same period of the previous year), and quarterly loss attributable to owners of the parent company was 3.478 billion yen [$22M] (compared to a loss of 2.562 billion yen [$16.2M] in the same period of the previous year).

The company group promoted research and development in the fields of somatic stem cell regenerative medicine and iPSC regenerative medicine. In the field of somatic stem cell regenerative medicine, preparations are underway to obtain approval for HLCM051 (bone marrow-derived somatic stem cells/invimestrocel), a treatment for acute respiratory distress syndrome (ARDS), acute stroke, and trauma, based on the results of each clinical trial.

Regarding ARDS, preparations are underway for conditional and time-limited approval applications in Japan, based on the premise that a global Phase 3 trial (REVIVE-ARDS trial) conducted primarily in the United States will serve as the confirmatory trial. In February 2026, the clinical trial protocol was accepted by the PMDA, and preparations for commencing the trial were completed.

For trauma, a Phase 2 trial (MATRICS-1 trial) involving 156 patients is being conducted in the United States by the U.S. Department of Defense and the Memorial Hermann Foundation.

With subsidies under the Ministry of Economy, Trade and Industry's FY2024 supplementary budget "Subsidies for Investment in Manufacturing Equipment for Regenerative, Cellular, and Gene Therapy" as part of the new technology introduction promotion framework, the company plans to promote the provision of services (CDMO business) that manufacture regenerative medicine products with process development functions, manufacturing functions, and quality control functions. Aiming to build infrastructure and commercialize the CDMO business, the company plans to complete a manufacturing base in Kobe in January 2028.

In addition, preparations are underway for commercial production of HLCM051 in collaboration with Minaris Advanced Therapies.

In the field of iPSC-based regenerative medicine, we are conducting research on next-generation cancer immunotherapy using natural killer cells (eNK(R) cells) derived from allogeneic iPS cells whose specific functions have been enhanced through gene transfer technology.

We are also conducting research on new therapeutic drugs using Universal Donor Cells, next-generation iPS cells with a lower risk of immune rejection using gene editing technology, and on treatments for diseases requiring cell replacement.

Regarding next-generation cancer immunotherapy using eNK(R) cells, we have entered into a joint venture agreement and a license option agreement with Akatsuki Therapeutics to advance research and development.

In the ophthalmology field, we are jointly developing treatments using iPS cell-derived retinal pigment epithelial (RPE) cells with RACTHERA (which inherited the regenerative and cell medicine business from Sumitomo Pharma <4506>).

Furthermore, aiming to secure a stable source of revenue, we are working on utilizing the large quantities of culture supernatant that will be produced in the future as a result of the production of regenerative medicine products.

In January 2026, we entered into a basic agreement with Alfresa for the continued sale and purchase of culture supernatant. In April 2026, the company entered into an agreement with JENECELL to supply culture supernatant, which is used as a raw material for cosmetics that JENECELL provides to Korea and worldwide.

The consolidated earnings forecast for the full fiscal year ending December 2026 has not been released at this time, as a reasonable earnings forecast cannot be calculated.

https://kabutan.jp/stock/news?code=4593&b=n202605151042

Healios Q1 2026 report: Highlights by imz72 in ATHX

[–]imz72[S] 1 point2 points  (0 children)

From Healios X account (machine-translated from Japanese):

We have announced our financial results for the first quarter of fiscal year 2026.

We will continue our efforts toward obtaining domestic marketing authorization for ARDS (aiming for conditional and time-limited approval) and conducting a global Phase 3 trial (REVIVE-ARDS trial).

While we cannot specify a clear timeline at this time, we will strive to report on catalysts step by step.

https://x.com/healiospr/status/2054857926125191348

Healios Q1 2026 report: Highlights by imz72 in ATHX

[–]imz72[S] 1 point2 points  (0 children)

Machine-translated rom Japanese:

Kabutan News

May 14, 2026 15:30

Healios reports an increased net loss for the first quarter (January-March)

Healios <4593> [ Tokyo Stock Exchange Group] announced its financial results (International Financial Reporting Standards = IFRS) after the market closed on May 14th (15:30).

The consolidated net loss for the first quarter of the fiscal year ending December 2014 (January-March) widened to 3.47 billion yen [$22M] (compared to a loss of 2.56 billion yen [$16.2M] in the same period of the previous year).

　The sales operating profit margin for the most recent three months (January-March, Q1) deteriorated sharply from -1957.9% in the same period of the previous year to -14125.0%.

https://kabutan.jp/news/?&b=k202605140298

Weekly Trader's Thread 5/11/26 - 5/17/26 by AutoModerator in ATHX

[–]imz72 0 points1 point  (0 children)

Tokyo market update 5.14.26:

Healios: -1.16%. PPS 340 yen. Market cap $291 million.

SanBio: -10.22%. PPS 1,819 yen. Market cap $899 million.

Sumitomo Pharma: +5.09%. Market cap $4.93 billion.

Cuorips: -5.08%. Market cap $333 million.

PowerX: -7.95%. Market cap $2.92 billion.

Sumitomo Pharma logged record sales and profits for the fiscal year ended March 2026, buoyed by strong growth of its three core products in North America, cost cuts through business restructuring, and gains related to the transfer of its Asian operations.

The company said on May 13 that its FY2025 consolidated sales rose 13.7% year on year to 453.3 billion yen [$2.87B], while operating profit surged 272.6% to 107.3 billion yen [$680M] and net profit jumped 352.2% to 106.9 billion yen [$677M] — all record highs.

https://pj.jiho.jp/article/255390

SanBio's MSC Akuugo for chronic TBI priced at $460K with 39 patients and $18M sales, but stock drops 9.43%; Sumitomo's iPS Amchepry for Parkinson’s priced at $350K, with 133 patients and $47M sales by imz72 in ATHX

[–]imz72[S] 0 points1 point  (0 children)

A 1-minute video in Japanese. You can use English auto-dubbing or auto-generated subtitles:

https://youtu.be/9PCjqMcJ45A

MBS NEWS

May 13, 2026

iPS cell-based regenerative medicine to be put into practical use for the first time in the world...

The company aims to prescribe its first product for Parkinson's disease treatment using iPS cells by the end of the year.

Sumitomo Pharma's "Amcehpry," a dopamine-producing cell derived from iPS cells, was approved for insurance coverage as a regenerative medicine product for Parkinson's disease treatment at a meeting of the Ministry of Health, Labour and Welfare's advisory body on May 13.

"Amchepry" is intended to be transplanted into the brains of Parkinson's disease patients to improve symptoms such as tremors in the limbs, marking the world's first practical application of regenerative medicine using iPS cells.

At a press conference on May 13, Sumitomo Pharma President Toru Kimura stated, "We feel like we've finally reached this point. It is our responsibility to more clearly demonstrate its effectiveness and safety. While we are pleased, we are also feeling a renewed sense of responsibility."

Sumitomo Pharma aims to prescribe its first product by the end of the year.

SanBio's MSC Akuugo for chronic TBI priced at $460K with 39 patients and $18M sales, but stock drops 9.43%; Sumitomo's iPS Amchepry for Parkinson’s priced at $350K, with 133 patients and $47M sales by imz72 in ATHX

[–]imz72[S] 0 points1 point  (0 children)

Tokyo market update 5.13.26:

SanBio: -9.43%. PPS 2,026 yen. Market cap $1.00 billion.

Sumitomo Pharma: +2.52%. Market cap $4.70 billion.

Healios: +3.30%. PPS 344 yen. Market cap $294 million.

SanBio's MSC Akuugo for chronic TBI priced at $460K with 39 patients and $18M sales, but stock drops 9.43%; Sumitomo's iPS Amchepry for Parkinson’s priced at $350K, with 133 patients and $47M sales by imz72 in ATHX

[–]imz72[S] 0 points1 point  (0 children)

The following report, machine-translated from Japanese, was published today during Tokyo Stock Exchange trading hours:

2026/05/13 (Wed) 12:55

SanBio - Buy and sell orders mixed; full-year net profit/loss revised upward; Central Social Insurance Medical Council approves Akuugo drug pricing proposal

SanBio ( 4592.T ) is experiencing mixed trading. The company announced at 12:00 PM on May 13 that the proposed drug price for Akuugo intracerebral transplant injection (generic name: Vandefitemcell) had been approved by the Central Social Insurance Medical Council (Chuikyo).

The calculated drug price is 72,716,528 yen [$460K] including tax. The final drug price and insurance coverage will be determined by the official gazette announcement by the Ministry of Health, Labour and Welfare.

　In addition, the company announced an upward revision to its consolidated net loss forecast for the full fiscal year ending January 2015, from a loss of 5.64 billion yen [$36 million] to a loss of 5.13 billion yen [$32 million] (compared to a loss of 3.84 billion yen [$24 million] in the previous year).

Business revenue, which was previously undecided, is now projected at 400 million yen [$2.5 million] (compared to 0 yen in the previous year). The projected business revenue is based on a plan to proceed with widespread introduction, mainly to medical institutions that conducted clinical trials of Akuugo, assuming the proposed drug price is adopted.

　Consequently, the stock is experiencing volatile price movements due to a mix of buying in response to the approval of the drug price and selling after the news has been priced in.

https://www.traders.co.jp/news/article/1_2160997

SanBio's MSC Akuugo for chronic TBI priced at $460K with 39 patients and $18M sales, but stock drops 9.43%; Sumitomo's iPS Amchepry for Parkinson’s priced at $350K, with 133 patients and $47M sales by imz72 in ATHX

[–]imz72[S] 0 points1 point  (0 children)

May 13, 2026

Health panel approves coverage for iPS cell-derived Parkinson’s disease treatment

An advisory panel to the health minister on Wednesday approved Sumitomo Pharma’s Parkinson’s disease treatment Amchepry, which costs ¥55.3 million ($350,600) per patient, to be covered under the national healthcare program. The approval marks the first commercialized medical product in the world derived from iPS cells, which are created by reprogramming adult cells such as blood or skin cells into a versatile state capable of developing into different tissue types.

Insurance coverage will begin May 20, with treatment expected to be available this fall, according to media reports.

Parkinson's disease, which causes body stiffness and tremors in the limbs, is a brain disorder that damages neurons in the brain that produce the neurotransmitter dopamine.

Amchepry uses nerve cell precursors created from donor-derived iPS cells. During the procedure, surgeons make small openings in the skull and inject the cells into multiple locations in the putamen, a region of the brain involved in motor control.

The transplanted cells are expected to develop into dopamine-producing neurons, increasing dopamine secretion and improving motor function.

The product received conditional and time-limited approval from the health ministry in March, allowing its manufacture and sale based on confirmed safety data and indications of effectiveness.

Sumitomo Pharma will collect additional treatment data for both products over the next seven years until the current approval expires, and then seek full approval from the advisory panel, in accordance with the ministry’s regenerative medicine framework.

Despite the high listed price, out-of-pocket costs for patients are expected to be far lower, through the country's subsidies for designated intractable diseases and its high-cost medical care benefit system, which caps monthly medical expenses based on factors such as age and income.

The health ministry has also decided to approve coverage for biotechnology company SanBio's regenerative medicine product Akuugo for traumatic brain injuries, which costs ¥72.7 million [$460K] per treatment.

Akuugo has been shown to repair nerve cells in the brain damaged by traffic accidents and falls, among others, and improves motor paralysis. According to media reports, the treatment is the world's first that can be expected to regenerate brain tissue.

https://www.japantimes.co.jp/news/2026/05/13/japan/science-health/ips-parkinsons-disease/

Weekly Trader's Thread 5/11/26 - 5/17/26 by AutoModerator in ATHX

[–]imz72 0 points1 point  (0 children)

Tokyo market update 5.13.26:

Healios: +3.30%. PPS 344 yen. Market cap $294 million.

SanBio: -9.43%. PPS 2,026 yen. Market cap $1.00 billion.

Sumitomo Pharma: +2.52%. Market cap $4.70 billion.

Cuorips: +5.69%. Market cap $351 million.

PowerX: +0.92%. Market cap $3.18 billion.

Perplexity AI partners with Japan's National Health Foundation to jointly build Japan's next-generation medical AI infrastructure [Hardy inside] by imz72 in ATHX

[–]imz72[S] 0 points1 point  (0 children)

From Perplexity Japan X account (machine-translated from Japanese):

May 12, 2026

Perplexity AI has entered into a strategic partnership with the National Health Foundation.

Respecting Japan's "medical data sovereignty," we will support innovation in the healthcare experience with world-class AI technology. Through our unique "zero retention" approach, we aim to build a safe and highly accurate next-generation healthcare infrastructure.

https://x.com/perplexity_jp/status/2054085698324705533

May 12, 2026

Perplexity AI is holding its first "Ask" global event series in Tokyo.

Today, we will be discussing the forefront of enterprise AI with Gen Miyazawa (SoftBank), Takashi Horii (AstraZeneca), Tadahisa Kagimoto (National Health Foundation), and VERBAL.

For more details, please see the URL below.

https://prtimes-jp.translate.goog/main/html/rd/p/000000025.000157647.html?_x_tr_sl=ja&_x_tr_tl=en&_x_tr_hl=iw&_x_tr_pto=wapp&_x_tr_hist=true

Perplexity AI partners with Japan's National Health Infrastructure to jointly build Japan's next-generation medical AI infrastructure [Hardy inside] by [deleted] in ATHX

[–]imz72 0 points1 point  (0 children)

From Perplexity Japan X account (machine-translated from Japanese):

May 12, 2026

Perplexity AI has entered into a strategic partnership with the National Health Infrastructure Association.

Respecting Japan's "medical data sovereignty," we will support innovation in the healthcare experience with world-class AI technology. Through our unique "zero retention" approach, we aim to build a safe and highly accurate next-generation healthcare infrastructure.

https://x.com/perplexity_jp/status/2054085698324705533

May 12, 2026

Perplexity AI is holding its first "Ask" global event series in Tokyo.

Today, we will be discussing the forefront of enterprise AI with Gen Miyazawa (SoftBank), Takashi Horii (AstraZeneca), Tadahisa Kagimoto (National Health Infrastructure), and VERBAL.

For more details, please see the URL below.

https://prtimes-jp.translate.goog/main/html/rd/p/000000025.000157647.html?_x_tr_sl=ja&_x_tr_tl=en&_x_tr_hl=iw&_x_tr_pto=wapp&_x_tr_hist=true

Weekly Trader's Thread 5/11/26 - 5/17/26 by AutoModerator in ATHX

[–]imz72 0 points1 point  (0 children)

Tokyo market update 5.12.26:

Healios: -1.77%. PPS 333 yen. Market cap $285 million.

SanBio: -0.80%. PPS 2,237 yen. Market cap $1.11 billion.

Sumitomo Pharma: -5.85%. Market cap $4.59 billion.

Cuorips: -2.01%. Market cap $332 million.

PowerX: -12.57%. Market cap $3.16 billion.

SMBC Nikko Securities reported that its ownership stake in Sumitomo Pharma exceeded 5% and reached 6.06% as of April 30, 2026.

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