Global Healthcare Analyst

Tina Banerjee

Equity Bottom-Up

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<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

Thematic (Sector/Industry)

<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

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<li>Hansoh Pharmaceutical obtained clinical trial approval for HS10587 tablets for advanced solid tumors. CSPC Pharmaceutical got registration approval for Aprepitant Injection for the prevention of postoperative nausea and vomiting.</li>
<li>Chugai Pharmaceutical’s partner Roche has decided to discontinue the clinical development of GYM329 (emugrobart). Otsuka is acquiring the U.S.-based Transcend Therapeutics for an upfront payment of $700M.</li>
<li>Celltrion will invest KRW 1.2T to construct Plants 4 and 5 at its Songdo campus. Alteogen entered license agreement with Biogen for development of subcutaneous formulations of biologics utilizing ALT-B4.</li>
</ul>


Hansoh Pharmaceutical obtained clinical trial approval for HS10587 tablets for advanced solid tumors. CSPC Pharmaceutical got registration approval for Aprepitant Injection for the prevention of postoperative nausea and vomiting.
Chugai Pharmaceutical’s partner Roche has decided to discontinue the clinical development of GYM329 (emugrobart). Otsuka is acquiring the U.S.-based Transcend Therapeutics for an upfront payment of $700M.
Celltrion will invest KRW 1.2T to construct Plants 4 and 5 at its Songdo campus. Alteogen entered license agreement with Biogen for development of subcutaneous formulations of biologics utilizing ALT-B4.


APAC Healthcare Weekly (March 29) – Hansoh, CSPC, Chugai, Takeda, Otsuka, Celltrion, Alteogen

<ul>
<li>Sino Biopharmaceutical entered outlicensing agreement with Sanofi for rovadicitinib for upfront payment of $135M. Antengene entered outlicensing agreement with UCB for ATG-201 for upfront and near-term milestone payment of $80M.</li>
<li>FDA accepted Takeda’s NDA for polycythemia vera drug rusfertide and granted Priority Review.  Sumitomo Pharma received conditional and time‑limited approval in Japan for the allogeneic cell product Amchepry.</li>
<li>FDA has cleared ABL Bio’s application for a Phase 1 clinical trial of ABL209. Glenmark Pharmaceuticals received FDA approval for generic Flovent with 180-day CGT exclusivity.</li>
</ul>


Sino Biopharmaceutical entered outlicensing agreement with Sanofi for rovadicitinib for upfront payment of $135M. Antengene entered outlicensing agreement with UCB for ATG-201 for upfront and near-term milestone payment of $80M.
FDA accepted Takeda’s NDA for polycythemia vera drug rusfertide and granted Priority Review.  Sumitomo Pharma received conditional and time‑limited approval in Japan for the allogeneic cell product Amchepry.
FDA has cleared ABL Bio’s application for a Phase 1 clinical trial of ABL209. Glenmark Pharmaceuticals received FDA approval for generic Flovent with 180-day CGT exclusivity.


APAC Healthcare Weekly (March 8) – Sino Bio, Antengene, Takeda, Sumitomo Pharma, ABL Bio, Glenmark

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<li>CStone Pharmaceuticals got additional indication approval for sugemalimab from UK MHRA in NSCLC. HBM Holdings entered into an exclusive license agreement and equity partnership agreement with Solstice Oncology.</li>
<li>Astellas Pharma and Vir Biotechnology entered a global strategic collaboration to advance VIR-5500 for prostate cancer. Bora Pharmaceuticals has renewed a five-year manufacturing partnership with GSK.</li>
<li>Lupin received EC approval for ranibizumab biosimilar. Zydus Lifesciences announces successful clinical development of pembrolizumab biosimilar candidate FYB206. FDA has accepted for review Dr. Reddy’s Laboratories’ BLA for Orencia biosimilar.</li>
</ul>


CStone Pharmaceuticals got additional indication approval for sugemalimab from UK MHRA in NSCLC. HBM Holdings entered into an exclusive license agreement and equity partnership agreement with Solstice Oncology.
Astellas Pharma and Vir Biotechnology entered a global strategic collaboration to advance VIR-5500 for prostate cancer. Bora Pharmaceuticals has renewed a five-year manufacturing partnership with GSK.
Lupin received EC approval for ranibizumab biosimilar. Zydus Lifesciences announces successful clinical development of pembrolizumab biosimilar candidate FYB206. FDA has accepted for review Dr. Reddy’s Laboratories’ BLA for Orencia biosimilar.


APAC Healthcare Weekly (March 1) – CStone, HBM, Astellas, Bora Pharma, Lupin, Zydus Lifesciences

Japan

ONO PHARMACEUTICAL CO., LTD. manufactures and sells pharmaceutical products. The Company mainly researches and develops prescription drugs.

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Ono Pharmaceutical (4528 JT)

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

APAC Healthcare Weekly (March 29) – Hansoh, CSPC, Chugai, Takeda, Otsuka, Celltrion, Alteogen

Hansoh got trial approval, while CSPC obtained new drug approval. Chugai’s partner is discontinuing development of emugrobart. Otsuka is acquiring...

Tina Banerjee

APAC Healthcare Weekly (March 8) – Sino Bio, Antengene, Takeda, Sumitomo Pharma, ABL Bio, Glenmark

Sino Bio and Anetengene stuck outlicensing deals with Sanofi and UCB, respectively. FDA accepted Takeda’s NDA for rusfertide. Sumitomo Pharma got...

Tina Banerjee

APAC Healthcare Weekly (March 1) – CStone, HBM, Astellas, Bora Pharma, Lupin, Zydus Lifesciences

CStone’s sugemalimab got label expansion in UK. HBM Holdings entered exclusive license agreement with Solstice Oncology. Astellas Pharma and Vir...

Tina Banerjee

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