Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<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>Leads Biolabs initiated Phase 2 clinical study evaluating LBL-024 for the first-line treatment of HCC. Henlius Biotech got FDA approval for Poherdy, as the first interchangeable biosimilar to Roche’s Perjeta.</li>
<li>Otsuka announced positive Phase 3 interim analysis of sibeprenlimab for immunoglobulin A nephropathy. ABL Bio signed technology transfer and joint R&amp;D agreement with Eli Lilly for upfront payment of $40M.</li>
<li>Boryung Pharmaceutical began construction to double its oral penicillin production capacity. Eubiologics published positive result from Phase 3 clinical trial evaluating EuTYPH-C, a typhoid conjugate vaccine.</li>
</ul>


Leads Biolabs initiated Phase 2 clinical study evaluating LBL-024 for the first-line treatment of HCC. Henlius Biotech got FDA approval for Poherdy, as the first interchangeable biosimilar to Roche’s Perjeta.
Otsuka announced positive Phase 3 interim analysis of sibeprenlimab for immunoglobulin A nephropathy. ABL Bio signed technology transfer and joint R&amp;D agreement with Eli Lilly for upfront payment of $40M.
Boryung Pharmaceutical began construction to double its oral penicillin production capacity. Eubiologics published positive result from Phase 3 clinical trial evaluating EuTYPH-C, a typhoid conjugate vaccine.


APAC Healthcare Weekly (November 16) – Leads Bio, Henlius Bio, Otsuka, ABL Bio, Boryung, Eubiologics

<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>Daiichi Sankyo’s indication expansion application for Enhertu has been accepted for review by FDA for certain types of breast cancers. Santen’s new drug application has been accepted in China.  </li>
<li>Hanmi Pharm entered into a global licensing agreement with Gilead Sciences granting Gilead the exclusive rights to develop and commercialize encequidar. Boryung is acquiring Sanofi’s cytotoxic anti-cancer drug Taxotere.</li>
<li>IHH Healthcare received SEBI approval for mandatory open offer for 26% stake in Fortis Healthcare. Lupin has launched Liraglutide prefilled pen, bioequivalent to Victoza, in the U.S.</li>
</ul>


Daiichi Sankyo’s indication expansion application for Enhertu has been accepted for review by FDA for certain types of breast cancers. Santen’s new drug application has been accepted in China.  
Hanmi Pharm entered into a global licensing agreement with Gilead Sciences granting Gilead the exclusive rights to develop and commercialize encequidar. Boryung is acquiring Sanofi’s cytotoxic anti-cancer drug Taxotere.
IHH Healthcare received SEBI approval for mandatory open offer for 26% stake in Fortis Healthcare. Lupin has launched Liraglutide prefilled pen, bioequivalent to Victoza, in the U.S.


APAC Healthcare Weekly (October 5) – Daiichi Sankyo, Santen, Hanmi Pharm, Boryung, IHH Health, Lupin

South Korea

Boryung Pharmaceutical Co., Ltd. produces over-the-counter medical drugs. The Company specializes in producing medicines in the fields of hypertension treatment and anti-viral.

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Boryung Pharmaceutical (003850 KS)

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 (November 16) – Leads Bio, Henlius Bio, Otsuka, ABL Bio, Boryung, Eubiologics

Henlius got FDA approval for Perjeta biosimilar. Otsuka reports positive Phase 3 trial result for sibepernlimab. ABL Bio signed deal with Lilly....

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 5) – Daiichi Sankyo, Santen, Hanmi Pharm, Boryung, IHH Health, Lupin

Daiichi Sankyo’s label expansion application for Enhertu has been accepted by FDA. Hanmi Pharm entered into global licensing agreement with Gilead...

Tina Banerjee

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