Global Healthcare Analyst

Tina Banerjee

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

<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

<ul>
<li>3SBio will spin-off and separately list the shares of Mandi, a subsidiary of the company. Celltrion got EC approval for Remsima IV liquid, world’s first liquid formulation of IV infliximab.</li>
<li>Hanmi Pharmaceutical is acquiring all of the issued and outstanding common shares of Aptose Biosciences that are not currently owned or controlled by Hanmi.</li>
<li>Otsuka got CHMP positive opinion for donidalorsen for the prevention of recurrent attacks of HAE. CSL plans to expand U.S. presence over the next five years, with ~$1.5B U.S. capex.</li>
</ul>


3SBio will spin-off and separately list the shares of Mandi, a subsidiary of the company. Celltrion got EC approval for Remsima IV liquid, world’s first liquid formulation of IV infliximab.
Hanmi Pharmaceutical is acquiring all of the issued and outstanding common shares of Aptose Biosciences that are not currently owned or controlled by Hanmi.
Otsuka got CHMP positive opinion for donidalorsen for the prevention of recurrent attacks of HAE. CSL plans to expand U.S. presence over the next five years, with ~$1.5B U.S. capex.


APAC Healthcare Weekly (November 23) – 3SBio, Celltrion, Hanmi Pharm, HK Inno.N, Otsuka, CSL

<ul>
<li>Takeda has dropped AstraZeneca-partnered antibody drug candidate from its pipeline. Eisai and Merck are closing late-stage trial of Lenvima plus Keytruda in hepatocellular carcinoma on disappointing result.</li>
<li>Wuxi AppTec sharpens CRDMO business by selling its China-based clinical research subsidiaries. FDA has designated Celltrion’s Stoboclo and Osenvelt as interchangeable biosimilars to the reference products Prolia and Xgeva, respectively.</li>
<li>CSL is delaying demerger of CSL Seqirus ‘to maximise shareholder value.’ PharmaEssentia has filed for the additional indication of Besremi for Essential Thrombocythemia (ET) with the FDA.</li>
</ul>


Takeda has dropped AstraZeneca-partnered antibody drug candidate from its pipeline. Eisai and Merck are closing late-stage trial of Lenvima plus Keytruda in hepatocellular carcinoma on disappointing result.
Wuxi AppTec sharpens CRDMO business by selling its China-based clinical research subsidiaries. FDA has designated Celltrion’s Stoboclo and Osenvelt as interchangeable biosimilars to the reference products Prolia and Xgeva, respectively.
CSL is delaying demerger of CSL Seqirus ‘to maximise shareholder value.’ PharmaEssentia has filed for the additional indication of Besremi for Essential Thrombocythemia (ET) with the FDA.


APAC Healthcare Weekly (November 2) – Takeda, Eisai, Wuxi AppTec, Celltrion, CSL, PharmaEssentia

<ul>
<li>Innovent Biologics announced strategic global collaboration with Takeda for total deal value of $11.4B. Akeso announced that phase 3 trial evaluating ivonescimab versus tislelizumab in sq-NSCLC met primary endpoint.</li>
<li>Celltrion received FDA approval for two additional pediatric indications for Humira biosimilar, Yuflyma. Classys plans to acquire 77.5% stake in JL Health, South American energy-based aesthetic medical device distribution group. </li>
<li>Syngene plans to add a bioconjugation suite at its commercial biologics facility. Cipla and Eli Lilly agreed to distribute and promote tirzepatide in India under a second brand name, Yurpeak.</li>
</ul>


Innovent Biologics announced strategic global collaboration with Takeda for total deal value of $11.4B. Akeso announced that phase 3 trial evaluating ivonescimab versus tislelizumab in sq-NSCLC met primary endpoint.
Celltrion received FDA approval for two additional pediatric indications for Humira biosimilar, Yuflyma. Classys plans to acquire 77.5% stake in JL Health, South American energy-based aesthetic medical device distribution group. 
Syngene plans to add a bioconjugation suite at its commercial biologics facility. Cipla and Eli Lilly agreed to distribute and promote tirzepatide in India under a second brand name, Yurpeak.


APAC Healthcare Weekly (October 26) – Innovent, Akeso, Celltrion, Classys, Daiichi, Syngene, Cipla

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)

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 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 (November 23) – 3SBio, Celltrion, Hanmi Pharm, HK Inno.N, Otsuka, CSL

3SBio will spin-off and separately list its subsidiary. Celltrion got EC approval for Remsima IV liquid. Hanmi Pharm is acquiring Aptose...

Tina Banerjee

APAC Healthcare Weekly (November 2) – Takeda, Eisai, Wuxi AppTec, Celltrion, CSL, PharmaEssentia

Takeda and Eisai witnessed clinical trials setback. Wuxi AppTec is selling China-based CRO subsidiaries. CSL is delaying demerger of CSL Seqirus....

Tina Banerjee

APAC Healthcare Weekly (October 26) – Innovent, Akeso, Celltrion, Classys, Daiichi, Syngene, Cipla

Innovent Biologics announced collaboration with Takeda. FDA approves two additional indications for Celltrion's Humira biosimilar. Syngene is...

Tina Banerjee

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