Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Hengrui Pharmaceuticals’ trastuzumab rezetecan got third indication approval in China for colorectal cancer. CSPC Pharma and AstraZeneca entered JV contract for the construction of new-generation biologics manufacturing facility in China.</li>
<li>Takeda Pharmaceutical got FDA approval for Orzeyful for narcolepsy type 1. As a first-in-class orexin treatment, Orzeyful is the only medicine indicated in the U.S. to treat the disease holistically.</li>
<li>Otsuka announced new data from the Phase 3 trial demonstrating that Voyxact stabilizes kidney function decline. Alteogen signed an exclusive license agreement with a global pharmaceutical company for ALT-B4. </li>
</ul>


Hengrui Pharmaceuticals’ trastuzumab rezetecan got third indication approval in China for colorectal cancer. CSPC Pharma and AstraZeneca entered JV contract for the construction of new-generation biologics manufacturing facility in China.
Takeda Pharmaceutical got FDA approval for Orzeyful for narcolepsy type 1. As a first-in-class orexin treatment, Orzeyful is the only medicine indicated in the U.S. to treat the disease holistically.
Otsuka announced new data from the Phase 3 trial demonstrating that Voyxact stabilizes kidney function decline. Alteogen signed an exclusive license agreement with a global pharmaceutical company for ALT-B4. 


APAC Healthcare Weekly (August 9) – Hengrui, CSPC Pharma, Takeda Pharma, Otsuka, Alteogen

Equity Bottom-Up

<ul>
<li>
<a href="https://www.smartkarma.com/entities/chugai-pharmaceutical-co-ltd" target="_blank" data-smartkarma-citation="entities:4489:1" rel="noopener">Chugai Pharmaceutical (4519 JP)</a> reported flat Hemlibra sales in 9M25 overcoming shipment issues. Higher volumes boosted Actemra revenue (up 27% YoY) amid declining in export unit price.</li>
<li>2025 guidance reiterated. Satisfactory progress after 9M25 with major line-items achieving 76-81% of full year guidance. Management expects to beat the export forecast in case of both Hemlibra and Actemra.</li>
<li>Strong progress of out-licensed products (nemluvio and orforglipron) with high sales potential will help drive growth in the short to medium term.</li>
</ul>



Chugai Pharmaceutical (4519 JP) reported flat Hemlibra sales in 9M25 overcoming shipment issues. Higher volumes boosted Actemra revenue (up 27% YoY) amid declining in export unit price.
2025 guidance reiterated. Satisfactory progress after 9M25 with major line-items achieving 76-81% of full year guidance. Management expects to beat the export forecast in case of both Hemlibra and Actemra.
Strong progress of out-licensed products (nemluvio and orforglipron) with high sales potential will help drive growth in the short to medium term.


Chugai Pharma (4519 JP): Hemlibra Steady, Actemra Shine, Outlicensed Drug and New Launches Key

<ul>
<li>Sichuan Kelub Biotech’s sac-TMT in combination with Keytruda as a first-line treatment for PD-L1-negative non-squamous NSCL) met primary endpoint. NMPA accepted CSPC Pharma’s NDA for Trastuzumab Envedotin (HER2-targeted ADC).</li>
<li>InSilico Medicine announced a multi-target strategic alliance with Bora Pharmaceuticals. Eisai secured FDA approval for a once-weekly Leqembi subcutaneous autoinjector as an initiation dose for Alzheimer’s disease.</li>
<li>Celltrion obtained domestic approval for Phase 1 clinical trials for its Tremfya biosimilar candidate, CT-P68. Mesoblast achieved target of 300 patients treated in Phase 3 trial of rexlemestrocel-L for CLBP.</li>
</ul>


Sichuan Kelub Biotech’s sac-TMT in combination with Keytruda as a first-line treatment for PD-L1-negative non-squamous NSCL) met primary endpoint. NMPA accepted CSPC Pharma’s NDA for Trastuzumab Envedotin (HER2-targeted ADC).
InSilico Medicine announced a multi-target strategic alliance with Bora Pharmaceuticals. Eisai secured FDA approval for a once-weekly Leqembi subcutaneous autoinjector as an initiation dose for Alzheimer’s disease.
Celltrion obtained domestic approval for Phase 1 clinical trials for its Tremfya biosimilar candidate, CT-P68. Mesoblast achieved target of 300 patients treated in Phase 3 trial of rexlemestrocel-L for CLBP.


APAC Healthcare Weekly (July 19) – Kelun Bio, CSPC Pharma, Insilico, Eisai, Celltrion, Mesoblast

<ul>
<li>Jiangsu Hengrui Pharmaceuticals received the NMPA approval for a new indication for dalpiciclib isethionate tablets. InSilico Medicine has achieved the first clinical milestone in its co-development collaboration with Hygtia Therapeutics.</li>
<li>Chugai has filed regulatory application in Japan for sparsentan for the treatment IgA nephropathy. Shionogi has invested in IVF company Dioseve through its corporate venture capital (CVC) initiatives.</li>
<li>Lupin launched Azilsartan Medoxomil tablets in the U.S. for the treatment of hypertension. Dr. Reddy’s Laboratories launched first-to file product Bosutinib tablets, a generic equivalent of Bosulif in the U.S.</li>
</ul>


Jiangsu Hengrui Pharmaceuticals received the NMPA approval for a new indication for dalpiciclib isethionate tablets. InSilico Medicine has achieved the first clinical milestone in its co-development collaboration with Hygtia Therapeutics.
Chugai has filed regulatory application in Japan for sparsentan for the treatment IgA nephropathy. Shionogi has invested in IVF company Dioseve through its corporate venture capital (CVC) initiatives.
Lupin launched Azilsartan Medoxomil tablets in the U.S. for the treatment of hypertension. Dr. Reddy’s Laboratories launched first-to file product Bosutinib tablets, a generic equivalent of Bosulif in the U.S.


APAC Healthcare Weekly (June 21) – Hengrui, InSilico Medicine, Chugai, Shionogi, Lupin, Dr. Reddy’s

<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

Japan

Chugai Pharmaceutical Company Ltd., manufactures and sells pharmaceuticals in the domestic and international markets through its subsidiaries. The Company develops drugs in the fields of cancer, infectious diseases, bone, blood, and circulatory systems. Chugai Pharmaceutical also conducts research studies on drugs with private and public medical research institutions.

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Chugai Pharmaceutical (4519 JP)

APAC Healthcare Weekly (August 9) – Hengrui, CSPC Pharma, Takeda Pharma, Otsuka, Alteogen

Hengrui’s trastuzumab rezetecan got 3rd indication approval in China. CSPC and AstraZeneca form JV for biologics manufacturing facility in China....

Tina Banerjee

Chugai Pharma (4519 JP): Hemlibra Steady, Actemra Shine, Outlicensed Drug and New Launches Key

Chugai Pharmaceutical (4519 JP) sees flat Hemlibra sales, higher Actemra revenue amid competition in 9M25. Strong progress in out-licensed...

Tina Banerjee

APAC Healthcare Weekly (July 19) – Kelun Bio, CSPC Pharma, Insilico, Eisai, Celltrion, Mesoblast

Kelun Biotech’s sac-TMT met primary endpoint in Phase 3 trial. FDA approves Eisai’s Leqembi Iqlik for Alzheimer’s starting therapy. Mesoblast met...

Tina Banerjee

APAC Healthcare Weekly (June 21) – Hengrui, InSilico Medicine, Chugai, Shionogi, Lupin, Dr. Reddy’s

Hengrui’s dalpiciclib got label expansion approval in China. Insilico achieved first milestone for co-development collaboration with Hygtia. Chugai...

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

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APAC Healthcare Weekly (August 9) – Hengrui, CSPC Pharma, Takeda Pharma, Otsuka, Alteogen

Hengrui’s trastuzumab rezetecan got 3rd indication approval in China. CSPC and AstraZeneca form JV for biologics manufacturing facility in China....

Tina Banerjee

Chugai Pharma (4519 JP): Hemlibra Steady, Actemra Shine, Outlicensed Drug and New Launches Key

​Chugai Pharmaceutical (4519 JP) sees flat Hemlibra sales, higher Actemra revenue amid competition in 9M25. Strong progress in out-licensed...

Tina Banerjee

APAC Healthcare Weekly (July 19) – Kelun Bio, CSPC Pharma, Insilico, Eisai, Celltrion, Mesoblast

Kelun Biotech’s sac-TMT met primary endpoint in Phase 3 trial. FDA approves Eisai’s Leqembi Iqlik for Alzheimer’s starting therapy. Mesoblast met...

Tina Banerjee

APAC Healthcare Weekly (June 21) – Hengrui, InSilico Medicine, Chugai, Shionogi, Lupin, Dr. Reddy’s

Hengrui’s dalpiciclib got label expansion approval in China. Insilico achieved first milestone for co-development collaboration with Hygtia. Chugai...

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

Chugai Pharmaceutical (4519 JP) sees flat Hemlibra sales, higher Actemra revenue amid competition in 9M25. Strong progress in out-licensed...