Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Sino Biopharmaceutical entered outlicensing deal with AstraZeneca for respiratory drug candidate TQC3721. Hansoh Pharmaceutical’s ADC drug candidate HS-20093 met primary endpoint of overall survival in Phase 3 trial for SCLC.</li>
<li>Wuxi Biologics’ Hebei drug substance manufacturing facility passed the Pre-License Inspection by the FDA. Astellas Pharma’s Padcev Keytruda combo was accepted for China review in perioperative muscle-invasive bladder cancer.</li>
<li>Otsuka’s Astex Pharmaceuticals inked R&amp;D deal with Genentech to identify small molecule breast cancer drug candidates. Celltrion’s Avastin biosimilar has secured formulary listings with two major PBMs in the U.S.</li>
</ul>


Sino Biopharmaceutical entered outlicensing deal with AstraZeneca for respiratory drug candidate TQC3721. Hansoh Pharmaceutical’s ADC drug candidate HS-20093 met primary endpoint of overall survival in Phase 3 trial for SCLC.
Wuxi Biologics’ Hebei drug substance manufacturing facility passed the Pre-License Inspection by the FDA. Astellas Pharma’s Padcev Keytruda combo was accepted for China review in perioperative muscle-invasive bladder cancer.
Otsuka’s Astex Pharmaceuticals inked R&amp;D deal with Genentech to identify small molecule breast cancer drug candidates. Celltrion’s Avastin biosimilar has secured formulary listings with two major PBMs in the U.S.


APAC Healthcare Weekly (July 12) – Sino Bio, Hansoh Pharma, Wuxi Bio, Astellas, Otsuka, Celltrion

<ul>
<li>Hansoh’s fourth-generation EGFR TKI HS-10504 tablets secured Breakthrough Therapy Designation in China for NSCLC. Junshi Biosciences got 13th indication expansion approval for toripalimab for HER2-expressing locally advanced or metastatic UC.</li>
<li>Daiichi Sankyo secured FDA approval for Enhertu’s two new breast cancer indications. The company’s Datroway got U.S. approval for TNBC. Japan approved NHI price for SanBio’s Akuugo.</li>
<li>Hanmi Pharmaceutical initiated domestic Phase 3 trial to expand indication for efpeglenatide beyond obesity to include the treatment of diabetes. Yuhan Corp signed $140M API supply contract with Gilead Sciences.</li>
</ul>


Hansoh’s fourth-generation EGFR TKI HS-10504 tablets secured Breakthrough Therapy Designation in China for NSCLC. Junshi Biosciences got 13th indication expansion approval for toripalimab for HER2-expressing locally advanced or metastatic UC.
Daiichi Sankyo secured FDA approval for Enhertu’s two new breast cancer indications. The company’s Datroway got U.S. approval for TNBC. Japan approved NHI price for SanBio’s Akuugo.
Hanmi Pharmaceutical initiated domestic Phase 3 trial to expand indication for efpeglenatide beyond obesity to include the treatment of diabetes. Yuhan Corp signed $140M API supply contract with Gilead Sciences.


APAC Healthcare Weekly (May 24)– Hansoh, Junshi Bio, Daiichi Sankyo, SanBio, Hanmi Pharm, Yuhan Corp

<ul>
<li>Hengrui Pharmaceuticals entered license agreements with BMS to advance 13 early-stage programs in oncology, hematology, and immunology. Sino Biopharmaceutical entered exclusive strategic collaboration with GlaxoSmithKline for Hepatitis B drug bepirovisen.</li>
<li>BeOne received FDA approval for Beqalzi for the treatment of mantle cell lymphoma. Otsuka’s subsidiary, Taiho Pharmaceutical secured FDA approval for Inqovi plus venetoclax for newly diagnosed acute myeloid leukemia.</li>
<li>Celltrion has acquired Gifrer, a 114-year-old local healthcare company in France. Bora Pharmaceuticals will acquire GMP manufacturing operations, including the CDMO business, of MacroGenics for $122.5M.</li>
</ul>


Hengrui Pharmaceuticals entered license agreements with BMS to advance 13 early-stage programs in oncology, hematology, and immunology. Sino Biopharmaceutical entered exclusive strategic collaboration with GlaxoSmithKline for Hepatitis B drug bepirovisen.
BeOne received FDA approval for Beqalzi for the treatment of mantle cell lymphoma. Otsuka’s subsidiary, Taiho Pharmaceutical secured FDA approval for Inqovi plus venetoclax for newly diagnosed acute myeloid leukemia.
Celltrion has acquired Gifrer, a 114-year-old local healthcare company in France. Bora Pharmaceuticals will acquire GMP manufacturing operations, including the CDMO business, of MacroGenics for $122.5M.


APAC Healthcare Weekly (May 17) – Hengrui, Sino Bio, BeOne, Otsuka, Celltrion, Bora Pharmaceuticals

<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>Henlius Biotech’s serplulimab is a step ahead for EU approval for two indications. InSilico Medicine inked a licensing and drug discovery collaboration with Eli Lilly for $115M upfront payment.</li>
<li>Shionogi completes acquisition of Radicava and stake increase in ViiV Healthcare. Mochida Pharmaceutical inked licensing deal with LG Chem for marketing of Dinagest in South Korea and Thailand.</li>
<li>Samsung Biologics has completed its acquisition of a manufacturing facility in Rockville, Maryland from GSK. SK Biopharmaceuticals has submitted NDA to the FDA for the oral suspension formulation of Xcopri.  </li>
</ul>


Henlius Biotech’s serplulimab is a step ahead for EU approval for two indications. InSilico Medicine inked a licensing and drug discovery collaboration with Eli Lilly for $115M upfront payment.
Shionogi completes acquisition of Radicava and stake increase in ViiV Healthcare. Mochida Pharmaceutical inked licensing deal with LG Chem for marketing of Dinagest in South Korea and Thailand.
Samsung Biologics has completed its acquisition of a manufacturing facility in Rockville, Maryland from GSK. SK Biopharmaceuticals has submitted NDA to the FDA for the oral suspension formulation of Xcopri.  


APAC Healthcare Weekly (April 5) – Henlius Biotech, InSilico, Shionogi, Samsung Bio, SK Biopharma

South Korea

Celltrion, Inc. produces and sells biosimilar products, as well as consignment processing services for other businesses.

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Celltrion (068270 KP)

APAC Healthcare Weekly (July 12) – Sino Bio, Hansoh Pharma, Wuxi Bio, Astellas, Otsuka, Celltrion

Sino Bio stuck outlicensing deal with AstraZeneca. Hansoh’s ADC drug candidate met primary endpoint in Phase 3 trial. China will review Astellas’...

Tina Banerjee

APAC Healthcare Weekly (May 24)– Hansoh, Junshi Bio, Daiichi Sankyo, SanBio, Hanmi Pharm, Yuhan Corp

Hansoh’s HS-10504 tablets secured BTD in China. Junshi Bio secured 13th indication approval for toripalimab. Daiichi Sanyo’s Enhertu and Datroway...

Tina Banerjee

APAC Healthcare Weekly (May 17) – Hengrui, Sino Bio, BeOne, Otsuka, Celltrion, Bora Pharmaceuticals

Hengrui stuck licensing agreement with BMS. Sino Bio enters exclusive collaboration with GSK. BeOne got FDA approval for new drug. Bora will...

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 (April 5) – Henlius Biotech, InSilico, Shionogi, Samsung Bio, SK Biopharma

Henlius’ serplulimab is a step ahead for EU approval for two indications. InSilico inked $2.75B deal with Lilly. SK Biopharmaceuticals applied for...

Tina Banerjee

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