Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/kyowa-kirin-co-ltd" target="_blank" data-smartkarma-citation="entities:18055:1" rel="noopener">Kyowa Kirin Co Ltd (4151 JP) </a>announced that ziftomenib is now commercially available in the U.S. Company will be eligible for 50% profit sharing from drug sales in the U.S.</li>
<li>Rocatinlimab, under Phase 3 trials, represents a potentially novel upstream approach for the management of mild to severe atopic dermatitis. It is also undergoing Phase 3 trials for Prurigo nodularis.</li>
<li>2026 will be an inflection point. Ziftomenib results will slowly fall in place. Positive results of rocatinlimab and new manufacturing facilities has potential to play out in long term.</li>
</ul>



Kyowa Kirin Co Ltd (4151 JP) announced that ziftomenib is now commercially available in the U.S. Company will be eligible for 50% profit sharing from drug sales in the U.S.
Rocatinlimab, under Phase 3 trials, represents a potentially novel upstream approach for the management of mild to severe atopic dermatitis. It is also undergoing Phase 3 trials for Prurigo nodularis.
2026 will be an inflection point. Ziftomenib results will slowly fall in place. Positive results of rocatinlimab and new manufacturing facilities has potential to play out in long term.


Kyowa Kirin (4151 JP): Ziftomenib Approval and Commercialization A Positive, What Lies Ahead?

Thematic (Sector/Industry)

<ul>
<li>CSPC Pharmaceutical’s Phase 3 trial of depression drug candidate HA1406 met pre-specified primary efficacy endpoint. Jiangsu Hengrui Pharmaceuticals received NMPA approval for long-acting basal insulin, sudelidec injection.</li>
<li>Otsuka Holdings secured FDA approval for Simtriyo, a once-daily extended-release capsule for ADHD. Nippon Shinyaku obtained exclusive commercialization rights for Tadekinig alfa in the U.S. for Hyperinflammatory Syndrome.</li>
<li>Pharmaessentia announced topline results from the Phase 1b clinical trial of P1101 (Besremi) and anti-PD1 in Chronic Hepatitis B or D. Cipla secured FDA approval for generic Advair Diskus.</li>
</ul>


CSPC Pharmaceutical’s Phase 3 trial of depression drug candidate HA1406 met pre-specified primary efficacy endpoint. Jiangsu Hengrui Pharmaceuticals received NMPA approval for long-acting basal insulin, sudelidec injection.
Otsuka Holdings secured FDA approval for Simtriyo, a once-daily extended-release capsule for ADHD. Nippon Shinyaku obtained exclusive commercialization rights for Tadekinig alfa in the U.S. for Hyperinflammatory Syndrome.
Pharmaessentia announced topline results from the Phase 1b clinical trial of P1101 (Besremi) and anti-PD1 in Chronic Hepatitis B or D. Cipla secured FDA approval for generic Advair Diskus.


APAC Healthcare Weekly (August 2) – CSPC, Hengrui, Otsuka, Nippon Shinyaku, PharmaEssnetia, Cipla

<ul>
<li>CSPC Pharmaceutical entered drug discovery collaboration with AstraZeneca in a deal worth of $1.7B+. Abbisko Cayman is collaborating with AstraZeneca to jointly develop a novel IO-TKI combination therapy for NSCLC.</li>
<li>Insilico inked AI drug discovery deal with Takeda Pharmaceutical worth up to $600M. Nippon Shinyaku secured exclusive worldwide rights to develop and commercialize EXG-7001 for DMD from Elixirgen Therapeutics.</li>
<li>Otsuka’s Voyxact demonstrated significant stabilization of kidney function, with evidence of improvement over two years in Phase 3 trial. EMA recommended to pull CSL’s Tavneos from sale in the EU.</li>
</ul>


CSPC Pharmaceutical entered drug discovery collaboration with AstraZeneca in a deal worth of $1.7B+. Abbisko Cayman is collaborating with AstraZeneca to jointly develop a novel IO-TKI combination therapy for NSCLC.
Insilico inked AI drug discovery deal with Takeda Pharmaceutical worth up to $600M. Nippon Shinyaku secured exclusive worldwide rights to develop and commercialize EXG-7001 for DMD from Elixirgen Therapeutics.
Otsuka’s Voyxact demonstrated significant stabilization of kidney function, with evidence of improvement over two years in Phase 3 trial. EMA recommended to pull CSL’s Tavneos from sale in the EU.


APAC Healthcare Weekly (July 5) – CSPC, Abbisko, Insilico, Takeda, Nippon Shinyaku, Otsuka, CSL

<ul>
<li>
<a href="https://www.smartkarma.com/entities/shionogi-co-ltd" target="_blank" data-smartkarma-citation="entities:19535:1" rel="noopener">Shionogi &amp; Co (4507 JP)</a> is acquiring the U.S.-based IntraBio for an upfront consideration of $2B. The acquisition would add FDA-approved rare disease drug Aqneursa to Shionogi’s growing portfolio.</li>
<li>As Shionogi is expanding rare disease presence globally, addition of Aqneursa after its acquisition of Radicava will deepen the company’s capability in rare diseases.</li>
<li>Expanding capabilities in rare disease front will facilitate to commercialize Shionogi’s rare disease pipeline, including zatolmilast (target launch in FY28) and S-606001 (expected launch in FY32).</li>
</ul>



Shionogi &amp; Co (4507 JP) is acquiring the U.S.-based IntraBio for an upfront consideration of $2B. The acquisition would add FDA-approved rare disease drug Aqneursa to Shionogi’s growing portfolio.
As Shionogi is expanding rare disease presence globally, addition of Aqneursa after its acquisition of Radicava will deepen the company’s capability in rare diseases.
Expanding capabilities in rare disease front will facilitate to commercialize Shionogi’s rare disease pipeline, including zatolmilast (target launch in FY28) and S-606001 (expected launch in FY32).


Shionogi & Co (4507 JP): Acquisition of IntraBio to Expand Rare Disease Portfolio

<ul>
<li>NMPA accepted Simcere’s resubmitted NDA for Rademikibart for the treatment of atopic dermatitis. FDA has granted Priority Review to Beigene’s indication expansion application for Tevimra in first-line gastroesophageal adenocarcinoma.</li>
<li>FDA has accepted Taiho Pharmaceutical’s NDA for NSCLC drug candidate zipalertinib. Kyowa Kirin and Kura Oncology initiated Japanese Phase 2 registrational clinical trial studying ziftomenib, for acute myeloid leukemia.</li>
<li>Sun Pharmaceutical is acquiring Organon for $14 per share in an all‑cash transaction with an enterprise valuation of $12B. The transaction is expected to close in early 2027.</li>
</ul>


NMPA accepted Simcere’s resubmitted NDA for Rademikibart for the treatment of atopic dermatitis. FDA has granted Priority Review to Beigene’s indication expansion application for Tevimra in first-line gastroesophageal adenocarcinoma.
FDA has accepted Taiho Pharmaceutical’s NDA for NSCLC drug candidate zipalertinib. Kyowa Kirin and Kura Oncology initiated Japanese Phase 2 registrational clinical trial studying ziftomenib, for acute myeloid leukemia.
Sun Pharmaceutical is acquiring Organon for $14 per share in an all‑cash transaction with an enterprise valuation of $12B. The transaction is expected to close in early 2027.


APAC Healthcare Weekly (May 3) – Simcere, Beigene, Otsuka, Kyowa Kirin, Sun Pharma

Japan

Kyowa Hakko Kirin Co.,Ltd. develops, manufactures, and markets pharmaceuticals. The Company's products include a protein produced by genetic recombination technology, an anti-anemia agent that attaches new sugar chains through partial modification of the amino acid sequence of human erythropoietin (EPO), and a glycoprotein, human erythropoietin.

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Kyowa Kirin Co Ltd (4151 JP)

Kyowa Kirin (4151 JP): Ziftomenib Approval and Commercialization A Positive, What Lies Ahead?

Kyowa Kirin's ziftomenib is now commercially available in the U.S. Rocatinlimab shows promise for atopic dermatitis and Prurigo nodularis in Phase...

Tina Banerjee

APAC Healthcare Weekly (August 2) – CSPC, Hengrui, Otsuka, Nippon Shinyaku, PharmaEssnetia, Cipla

Hengrui got NMPA approval for long-acting insulin. FDA approves Otsuka’s new CNS drug. Pharmaessentia announced positive topline result from Phase...

Tina Banerjee

APAC Healthcare Weekly (July 5) – CSPC, Abbisko, Insilico, Takeda, Nippon Shinyaku, Otsuka, CSL

CSPC, Insilico, and Abiisko inked outlicensing deals with international companies. Nippon Shinyaku inlicenses DMD drug candidate. EMA recommends to...

Tina Banerjee

Shionogi & Co (4507 JP): Acquisition of IntraBio to Expand Rare Disease Portfolio

Shionogi is acquiring the U.S.-based IntraBio for an upfront consideration of $2B. The acquisition would add FDA-approved rare disease drug...

Tina Banerjee

APAC Healthcare Weekly (May 3) – Simcere, Beigene, Otsuka, Kyowa Kirin, Sun Pharma

NMPA accepted Simcere’s resubmitted NDA for Rademikibart. Beigene got FDA’s priority review for label expansion of Tevimra. Sun Pharma is acquiring...

Tina Banerjee

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Kyowa Kirin (4151 JP): Ziftomenib Approval and Commercialization A Positive, What Lies Ahead?

​Kyowa Kirin's ziftomenib is now commercially available in the U.S. Rocatinlimab shows promise for atopic dermatitis and Prurigo nodularis in Phase...

Tina Banerjee

APAC Healthcare Weekly (August 2) – CSPC, Hengrui, Otsuka, Nippon Shinyaku, PharmaEssnetia, Cipla

Hengrui got NMPA approval for long-acting insulin. FDA approves Otsuka’s new CNS drug. Pharmaessentia announced positive topline result from Phase...

Tina Banerjee

APAC Healthcare Weekly (July 5) – CSPC, Abbisko, Insilico, Takeda, Nippon Shinyaku, Otsuka, CSL

CSPC, Insilico, and Abiisko inked outlicensing deals with international companies. Nippon Shinyaku inlicenses DMD drug candidate. EMA recommends to...

Tina Banerjee

Shionogi & Co (4507 JP): Acquisition of IntraBio to Expand Rare Disease Portfolio

Shionogi is acquiring the U.S.-based IntraBio for an upfront consideration of $2B. The acquisition would add FDA-approved rare disease drug...

Tina Banerjee

APAC Healthcare Weekly (May 3) – Simcere, Beigene, Otsuka, Kyowa Kirin, Sun Pharma

NMPA accepted Simcere’s resubmitted NDA for Rademikibart. Beigene got FDA’s priority review for label expansion of Tevimra. Sun Pharma is acquiring...

Tina Banerjee

Kyowa Kirin's ziftomenib is now commercially available in the U.S. Rocatinlimab shows promise for atopic dermatitis and Prurigo nodularis in Phase...