Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Simcere entered outlicensing agreement with Boehringer Ingelheim for IBD drug candidate SIM0709 for upfront payment of €42M. CSPC entered collaboration and license agreement with AstraZeneca for upfront payment of $1.2B.</li>
<li>Hanmi Pharm signs exclusive Mexico distribution deal for GLP-1 obesity drug efpeglenatide. HK inno.N will be launching 'X1 Plus Tablet', a triple antihypertensive drug for the first time in Korea.</li>
<li>Eisai’s Leqembi autoinjector is now under FDA review as weekly starting dose, with target action date of May 24. Chugai Pharmaceutical filed for additional indication of Tecentriq for bladder cancer.</li>
</ul>


Simcere entered outlicensing agreement with Boehringer Ingelheim for IBD drug candidate SIM0709 for upfront payment of €42M. CSPC entered collaboration and license agreement with AstraZeneca for upfront payment of $1.2B.
Hanmi Pharm signs exclusive Mexico distribution deal for GLP-1 obesity drug efpeglenatide. HK inno.N will be launching 'X1 Plus Tablet', a triple antihypertensive drug for the first time in Korea.
Eisai’s Leqembi autoinjector is now under FDA review as weekly starting dose, with target action date of May 24. Chugai Pharmaceutical filed for additional indication of Tecentriq for bladder cancer.


APAC Healthcare Weekly (February 1) – Simcere, CSPC, Hanmi Pharm, HK Inno.N, Eisai, Chugai Pharma

<ul>
<li>Sino Biopharmaceutical initiated Phase 1 trial for innovative drug candidate TQB6411 targeting advanced malignant tumors in China. Wuxi Biologics announced that five manufacturing facilities passed the Pre-License Inspection by FDA.</li>
<li>FDA drug advisory committee voted against Otsuka’s indication expansion application for Rexulti. Telix Pharmaceutical received a subpoena from the SEC regarding the development of prostate cancer therapeutic candidates. </li>
<li>Lupin received FDA approval for generic versions of Liraglutide and Glucagon injections. Sun Pharmaceutical announced positive top-line results from two Phase 3 trials of Ilumya in active psoriatic arthritis.</li>
</ul>


Sino Biopharmaceutical initiated Phase 1 trial for innovative drug candidate TQB6411 targeting advanced malignant tumors in China. Wuxi Biologics announced that five manufacturing facilities passed the Pre-License Inspection by FDA.
FDA drug advisory committee voted against Otsuka’s indication expansion application for Rexulti. Telix Pharmaceutical received a subpoena from the SEC regarding the development of prostate cancer therapeutic candidates. 
Lupin received FDA approval for generic versions of Liraglutide and Glucagon injections. Sun Pharmaceutical announced positive top-line results from two Phase 3 trials of Ilumya in active psoriatic arthritis.


APAC Healthcare Weekly (July 27) – Sino Bio, Wuxi Bio, Otsuka, Telix, Lupin, Sun Pharma

<ul>
<li>Shionogi is acquiring Torii Pharmaceutical and pharmaceutical business of Japan Tobacco. Daiichi Sankyo’s Enhertu meets main goal in the neoadjuvant setting (before surgery) in early-stage breast cancer trial.</li>
<li>HK inno.N received approval for the domestic phase 3 clinical trial of obesity drug candidate. Neuren Pharmaceuticals’ Daybue recorded $84.6M revenue in the U.S. in 1Q25, up 11% YoY.</li>
<li>Biocon secured multiple market access agreements for Yesintek, its biosimilar to Stelara. Lupin received FDA approval for antiretroviral agent raltegravir tablets for the treatment of human immunodeficiency virus (HIV-1) infection.</li>
</ul>


Shionogi is acquiring Torii Pharmaceutical and pharmaceutical business of Japan Tobacco. Daiichi Sankyo’s Enhertu meets main goal in the neoadjuvant setting (before surgery) in early-stage breast cancer trial.
HK inno.N received approval for the domestic phase 3 clinical trial of obesity drug candidate. Neuren Pharmaceuticals’ Daybue recorded $84.6M revenue in the U.S. in 1Q25, up 11% YoY.
Biocon secured multiple market access agreements for Yesintek, its biosimilar to Stelara. Lupin received FDA approval for antiretroviral agent raltegravir tablets for the treatment of human immunodeficiency virus (HIV-1) infection.


APAC Healthcare Weekly (May 11)- Shionogi, Daiichi Sankyo, HK Inno, Neuren, Biocon, Aster DM, Lupin

<ul>
<li>Eisai is eyeing for Leqembi global revenue of ¥250–280B in FY28. Kaken Pharmaceutical inlicensed dermatology drug candidate from Alumis. Kaken’s onychomycosis drug got approval in Italy.</li>
<li>Mochida Pharmaceutical has applied for marketing approval of Actembra biosimilar in Japan. Shionogi has filed for indication expansion of Xocova for post-exposure prophylaxis of COVID-19 in Japan.</li>
<li>SK Bioscience got approval for Phase 3 clinical trial of 21-valent pneumococcal vaccine in European countries. PharmaEssential obtained approval for Phase 3 clinical trial of Ropeginterferon alfa-2b in China.</li>
</ul>


Eisai is eyeing for Leqembi global revenue of ¥250–280B in FY28. Kaken Pharmaceutical inlicensed dermatology drug candidate from Alumis. Kaken’s onychomycosis drug got approval in Italy.
Mochida Pharmaceutical has applied for marketing approval of Actembra biosimilar in Japan. Shionogi has filed for indication expansion of Xocova for post-exposure prophylaxis of COVID-19 in Japan.
SK Bioscience got approval for Phase 3 clinical trial of 21-valent pneumococcal vaccine in European countries. PharmaEssential obtained approval for Phase 3 clinical trial of Ropeginterferon alfa-2b in China.


APAC Healthcare Weekly (Mar 30)- Eisai, Kaken, Mochida, Shionogi, SK Bioscience, PharmaEssentia

'Quantamental' Japan Specialist, LightStream Research

Campbell Gunn

'Quantamental' Japan Specialist

Long-Short Analysis on Japan, Asia and the World

LightStream Research

LightStream conducts quantitatively rigorous and data-driven analysis with a focus on Japan and Asia.

We consistently cover the Tech, Consumer and Industrial sectors, and provide ECM and Events coverage more broadly.

We supplement traditional qualitative insights from company relationships with a robust quantitative foundation that examines as much historical data as is available.
We further refine the accuracy of our insights and calls through the use of alternative data to flesh out current trends, and through a valuation framework that emphasises non-superficial peer group selection and a proper attempt to understand the metrics and changes that have driven security valuations in the past.

<figure class="editor-figure mceNonEditable"><img src="https://static-prod.smartkarma.com/images/media/000/129/661/original/2020-04-26_07-20-46.png?1587853286" class="editor-image img-responsive" data-smartkarma-image-id="129661"></figure><div class="content-caption">Source • Japan Analytics</div><p><strong>THE WEDGE</strong> - Both Japanese equities and the $/¥ exchange rate have traded in a narrow range over the last two weeks. Undeterred, the Bank of Japan intervened through ETF purchases three times last week. In total, since the low of March 16th, the central bank has bought ETFs equivalent to 3.5% of market value, and have supported a 15% 29-day rally. As the markets consolidate in anticipation of the impending 'rendezvous with reality' in the form of quarterly earnings, the resolution of the 'wedge' formations above will be to the downside.</p><figure class="editor-figure mceNonEditable"><img src="https://static-prod.smartkarma.com/images/media/000/129/662/original/2020-04-26_07-39-05.png?1587854366" class="editor-image img-responsive" data-smartkarma-image-id="129662"></figure><div class="content-caption">Source • Japan Analytics</div><p><strong>CANARIES</strong> - As we noted in Friday's <a href="https://www.smartkarma.com/insights/japan-revisions-results-23rd-april-getting-worse-rapidly-obics-tgas-canon-omron" target="_blank" data-smartkarma-citation="insights:38697" rel="noopener">Results Review</a>, interim forecasts are a useful 'canary' and, with some help from <a href="https://www.smartkarma.com/entities/fanuc-corp" target="_blank" data-smartkarma-citation="entities:752:1" rel="noopener">Fanuc (6954 JP)</a>, our composite Score is heading lower rapidly. A growing number of companies lacking Fanuc's candour are refusing to make initial full-year or interim forecasts this year leaving the market, and the sell-side, to 'fly blind'. The lack of foresight is resulting in a degree of misplaced optimism, as amply demonstrated by Friday's 7.5% gain in <a href="https://www.smartkarma.com/entities/omron-corp" target="_blank" data-smartkarma-citation="entities:15904:1" rel="noopener">Omron (6645 JP)</a> for 'beating' a six-month-old forecast for a mostly pre-COVID-19 year.     </p><figure class="editor-figure mceNonEditable"><img src="https://static-prod.smartkarma.com/images/media/000/129/665/original/File%202020-04-26%205%2006%2033.jpeg?1587856452" class="editor-image img-responsive" data-smartkarma-image-id="129665"></figure><figure class="editor-figure mceNonEditable"><img src="https://static-prod.smartkarma.com/images/media/000/129/666/original/File%202020-04-26%205%2007%2018.jpeg?1587856466" class="editor-image img-responsive" data-smartkarma-image-id="129666"></figure><p><strong>PERSISTENCE</strong> - Japan is still 'behind' the world and ahead of the rest of Asia in COVID-19 metrics - Marco Piani's excellent global timeline chart is attached as an Appendix in the DETAIL below. The number of confirmed new cases is persistent at around 300, of which, alarmingly, an increasing number are outside Tokyo, while the rolling 3-day number of deaths is moving more towards Europe than the rest of Asia. The northern island of Hokkaido which saw some of the earliest case clusters in Japan is experiencing a second wave of infections.  Nishimura, the Cabinet minister in charge of the response to COVID-19, is now in quarantine at home after one of his aides tested positive. Sunday has brought some welcome good news - the nationwide daily case count has declined to 140. <strong>Nevertheless, with just ten days until the proposed end of the states of emergency, at least one extension is likely, possibly until the end of May. Such a declaration is not yet discounted in the equity market.</strong></p><figure class="editor-figure mceNonEditable"><img src="https://static-prod.smartkarma.com/images/media/000/129/667/original/IMG_1515.jpg?1587857128" class="editor-image img-responsive" data-smartkarma-image-id="129667"></figure><div class="content-caption">Source • NHK</div><p><strong>PREVALENCE</strong> - Although a lack of widespread testing biases this data, the detected rates of infection by age cohort (descending in the chart above) and sex (male blue/female red) reveal the consequences of Japan's version of social distancing. The highest rates of infection are amongst those that have to commute or come into contact with others, men between the ages of 20 and 50 and childless women in their twenties, many of whom work in hospitals or check-out counters. 10% of all COVID-19 cases in Japan are medical staff or patients who were infected nosocomially.  Testing is still a major bottleneck due to excessive fax-centric bureaucracy and reliance on only non-private institutions. Only 6,000 tests are being carried out every day, two-thirds of total capacity, and the results take one week to obtain. </p><p><strong>PLEASE DIE AT HOME</strong> - A number of those infected with COVID-19 who have been told to 'stay home' as the hospitals are full are now dying in situ or on the street. Some local governments are being forced to change tack. All newly-confirmed patients that cannot be accommodated in hospitals are to be moved to hotels with medical staff in attendance. However, there is now a severe shortage of such personnel. Hospitals in Tokyo are still turning away suspected COVID-19 patients. Aichi prefecture has resorted to offering 'subsidies' of up to ¥4 million to hospitals for accepting new patients.</p><p><strong>ANTI-SOCIAL BEHAVIOUR</strong> - Japan is not immune to anti-social behaviour at the worst of times. Cars with license plates from other prefectures have been vandalised when parked or tailgated or verbally-abused on the road. Child care facilities are turning away children of hospital staff for fear they may already be asymptomatic carriers, prompting many medical workers to quit their jobs. Some companies are requiring employees who are working from home to be monitored by video during working hours to ensure they are at their desks and not helping out with the housework.</p><figure class="editor-figure mceNonEditable"><img src="https://static-prod.smartkarma.com/images/media/000/129/670/original/title_1.jpg?1587859428" class="editor-image img-responsive" data-smartkarma-image-id="129670"></figure><div class="content-caption">Source • Sharp</div><p><strong>ABE-'NO-MASKS'</strong><strong>AND THE SHARP LOTTERY</strong> - The government has had to recall the small washable cloth masks that PM Abe planned to distribute two of per household due to mould, stains and insects being found in up to one-third of early batches. The roll-out of these much-criticised 'Abe masks' will be further delayed. Meanwhile, demand for <a href="https://www.smartkarma.com/entities/sharp-corp" target="_blank" data-smartkarma-citation="entities:391:1" rel="noopener">Sharp (6753 JP)</a>'s newly-manufactured higher quality single-use masks so overwhelmed the company's website, that Sharp has decided to hold a lottery as a way of rationing demand.</p><figure class="editor-figure mceNonEditable"><img src="https://static-prod.smartkarma.com/images/media/000/129/725/original/2020-04-26_15-42-04.png?1587883347" class="editor-image img-responsive" data-smartkarma-image-id="129725"></figure><div class="content-caption">Source ♦ Japan Analytics</div><p>In the<strong> DETAIL</strong> below, we shall review the results, revisions and initial forecast announcements made on Friday by larger-cap companies.  The positive/neutral/negative balance for Friday's 28 results announcements was 13:1:14, and the net change in Results Score was -1. For the 47 revisions/forecasts, the split was 21:2:24 but the net change in Revision Score totalled -170. Of the eighteen companies declaring full-year results, only half made interim or annual forecasts for the current year. As we shall see below the 'worst' forecasts were from <a href="https://www.smartkarma.com/entities/fanuc-corp" target="_blank" data-smartkarma-citation="entities:752:1" rel="noopener">Fanuc (6954 JP)</a>, <a href="https://www.smartkarma.com/entities/amano-corp" target="_blank" data-smartkarma-citation="entities:8135:1" rel="noopener">Amano (6436 JP)</a>, <a href="https://www.smartkarma.com/entities/ana-holdings-inc" target="_blank" data-smartkarma-citation="entities:5308:1" rel="noopener">ANA (9202 JP)</a>, and <a href="https://www.smartkarma.com/entities/denso-corp" target="_blank" data-smartkarma-citation="entities:18703:1" rel="noopener">Denso (6902 JP)</a> (see chart above). Large=caps with improved Revisions Scores were <a href="https://www.smartkarma.com/entities/mochida-pharmaceutical-co" target="_blank" data-smartkarma-citation="entities:3655:1" rel="noopener">Mochida Pharmaceutical (4534 JP)</a>, <a href="https://www.smartkarma.com/entities/okinawa-cellular-telephone" target="_blank" data-smartkarma-citation="entities:6517:1" rel="noopener">Okinawa Cellular Telephone (9436 JP)</a> and <a href="https://www.smartkarma.com/entities/acom-co-ltd" target="_blank" data-smartkarma-citation="entities:8897:1" rel="noopener">Acom (8572 JP)</a>. <a href="https://www.smartkarma.com/entities/shionogi-co-ltd" target="_blank" data-smartkarma-citation="entities:19535:1" rel="noopener">Shionogi (4507 JP)</a> and two other companies raised dividends; none cut their payouts.</p>

Source • Japan AnalyticsTHE WEDGE - Both Japanese equities and the $/¥ exchange rate have traded in a narrow range over the last two weeks. Undeterred, the Bank of Japan intervened through ETF purchases three times last week. In total, since the low of March 16th, the central bank has bought ETFs equivalent to 3.5% of market value, and have supported a 15% 29-day rally. As the markets consolidate in anticipation of the impending 'rendezvous with reality' in the form of quarterly earnings, the resolution of the 'wedge' formations above will be to the downside.Source • Japan AnalyticsCANARIES - As we noted in Friday's Results Review, interim forecasts are a useful 'canary' and, with some help from Fanuc (6954 JP), our composite Score is heading lower rapidly. A growing number of companies lacking Fanuc's candour are refusing to make initial full-year or interim forecasts this year leaving the market, and the sell-side, to 'fly blind'. The lack of foresight is resulting in a degree of misplaced optimism, as amply demonstrated by Friday's 7.5% gain in Omron (6645 JP) for 'beating' a six-month-old forecast for a mostly pre-COVID-19 year.     PERSISTENCE - Japan is still 'behind' the world and ahead of the rest of Asia in COVID-19 metrics - Marco Piani's excellent global timeline chart is attached as an Appendix in the DETAIL below. The number of confirmed new cases is persistent at around 300, of which, alarmingly, an increasing number are outside Tokyo, while the rolling 3-day number of deaths is moving more towards Europe than the rest of Asia. The northern island of Hokkaido which saw some of the earliest case clusters in Japan is experiencing a second wave of infections.  Nishimura, the Cabinet minister in charge of the response to COVID-19, is now in quarantine at home after one of his aides tested positive. Sunday has brought some welcome good news - the nationwide daily case count has declined to 140. Nevertheless, with just ten days until the proposed end of the states of emergency, at least one extension is likely, possibly until the end of May. Such a declaration is not yet discounted in the equity market.Source • NHKPREVALENCE - Although a lack of widespread testing biases this data, the detected rates of infection by age cohort (descending in the chart above) and sex (male blue/female red) reveal the consequences of Japan's version of social distancing. The highest rates of infection are amongst those that have to commute or come into contact with others, men between the ages of 20 and 50 and childless women in their twenties, many of whom work in hospitals or check-out counters. 10% of all COVID-19 cases in Japan are medical staff or patients who were infected nosocomially.  Testing is still a major bottleneck due to excessive fax-centric bureaucracy and reliance on only non-private institutions. Only 6,000 tests are being carried out every day, two-thirds of total capacity, and the results take one week to obtain. PLEASE DIE AT HOME - A number of those infected with COVID-19 who have been told to 'stay home' as the hospitals are full are now dying in situ or on the street. Some local governments are being forced to change tack. All newly-confirmed patients that cannot be accommodated in hospitals are to be moved to hotels with medical staff in attendance. However, there is now a severe shortage of such personnel. Hospitals in Tokyo are still turning away suspected COVID-19 patients. Aichi prefecture has resorted to offering 'subsidies' of up to ¥4 million to hospitals for accepting new patients.ANTI-SOCIAL BEHAVIOUR - Japan is not immune to anti-social behaviour at the worst of times. Cars with license plates from other prefectures have been vandalised when parked or tailgated or verbally-abused on the road. Child care facilities are turning away children of hospital staff for fear they may already be asymptomatic carriers, prompting many medical workers to quit their jobs. Some companies are requiring employees who are working from home to be monitored by video during working hours to ensure they are at their desks and not helping out with the housework.Source • SharpABE-'NO-MASKS'AND THE SHARP LOTTERY - The government has had to recall the small washable cloth masks that PM Abe planned to distribute two of per household due to mould, stains and insects being found in up to one-third of early batches. The roll-out of these much-criticised 'Abe masks' will be further delayed. Meanwhile, demand for Sharp (6753 JP)'s newly-manufactured higher quality single-use masks so overwhelmed the company's website, that Sharp has decided to hold a lottery as a way of rationing demand.Source ♦ Japan AnalyticsIn the DETAIL below, we shall review the results, revisions and initial forecast announcements made on Friday by larger-cap companies.  The positive/neutral/negative balance for Friday's 28 results announcements was 13:1:14, and the net change in Results Score was -1. For the 47 revisions/forecasts, the split was 21:2:24 but the net change in Revision Score totalled -170. Of the eighteen companies declaring full-year results, only half made interim or annual forecasts for the current year. As we shall see below the 'worst' forecasts were from Fanuc (6954 JP), Amano (6436 JP), ANA (9202 JP), and Denso (6902 JP) (see chart above). Large=caps with improved Revisions Scores were Mochida Pharmaceutical (4534 JP), Okinawa Cellular Telephone (9436 JP) and Acom (8572 JP). Shionogi (4507 JP) and two other companies raised dividends; none cut their payouts.

🇯🇵 JAPAN MARKET (& COVID-19) UPDATE 26th April - Thin End of the Wedge

Japan

Mochida Pharmaceutical Co., Ltd. produces and sells a variety of pharmaceuticals and skin care products.  The Company's main product is circulatory agents. Mochida Pharmaceutical also distributes medical instruments and equipment used for surgery and diagnosis.

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Mochida Pharmaceutical (4534 JP)

APAC Healthcare Weekly (February 1) – Simcere, CSPC, Hanmi Pharm, HK Inno.N, Eisai, Chugai Pharma

CSPC and Simcere signed outlicensing deals with AstraZeneca and Boehringer Ingelheim, respectively. Eisai’s Leqembi autoinjector is now under FDA...

Tina Banerjee

APAC Healthcare Weekly (July 27) – Sino Bio, Wuxi Bio, Otsuka, Telix, Lupin, Sun Pharma

Wuxi Bio’s manufacturing facilities passed FDA inspection. Otsuka’s label expansion plan for Rexulti is in jeopardy. Telix got SEC subpoena. Lupin...

Tina Banerjee

APAC Healthcare Weekly (May 11)- Shionogi, Daiichi Sankyo, HK Inno, Neuren, Biocon, Aster DM, Lupin

Shionogi is acquiring Torii Pharma. Daiichi Sankyo’s Enhertu meets key goal in breast cancer trial. HK inno got domestic approval for P3 trial of...

Tina Banerjee

APAC Healthcare Weekly (Mar 30)- Eisai, Kaken, Mochida, Shionogi, SK Bioscience, PharmaEssentia

Eisai outlined Leqembi sales target. Kaken inlicensed drug candidate. Mochida filed for Actembra biosimilar. Shionogi applied for label expansion...

Tina Banerjee

🇯🇵 JAPAN MARKET (& COVID-19) UPDATE 26th April - Thin End of the Wedge

THE WEDGE - Both Japanese equities and the $/¥ exchange rate have traded in a narrow range over the last two weeks. Undeterred, the Bank of Japan...

Campbell Gunn

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