Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>Eli Lilly announced positive topline results from Phase 3 trial, evaluating orforglipron, discovered by Chugai. Hisamitsu Pharmaceutical initiated Phase 3 trial of HP-6050, a transdermal formulation for sedation in Japan.</li>
<li>WuXi XDC completed GMP release of its new drug product facility in China. CSPC Pharmaceutical’s application for marketing approval of Semaglutide Injection has been accepted by the NMPA of China.</li>
<li>Junshi Biosciences’s indication expansion application for toripalimab for treatment of urothelial carcinoma has been accepted in China. Hanmi Pharma advances HM17321, a first-in-class obesity therapy, into global Phase 1 trials.</li>
</ul>


Eli Lilly announced positive topline results from Phase 3 trial, evaluating orforglipron, discovered by Chugai. Hisamitsu Pharmaceutical initiated Phase 3 trial of HP-6050, a transdermal formulation for sedation in Japan.
WuXi XDC completed GMP release of its new drug product facility in China. CSPC Pharmaceutical’s application for marketing approval of Semaglutide Injection has been accepted by the NMPA of China.
Junshi Biosciences’s indication expansion application for toripalimab for treatment of urothelial carcinoma has been accepted in China. Hanmi Pharma advances HM17321, a first-in-class obesity therapy, into global Phase 1 trials.


APAC Healthcare Weekly (Aug 10) – Chugai, Hisamitsu, Wuxi XDC, CSPC Pharma, Junshi Bio, Hanmi Pharma

<ul>
<li>Shanghai Henlius Biotech initiated Phase 3 U.S. clinical trial for HLX22 for gastroesophageal junction and gastric cancer. CanSino Biologics obtained clinical trial approval in China for polio vaccine.</li>
<li>FDA rejected Nippon Shinyaku’s new drug application for CAP-1002 for DMD. JCR Pharmaceuticals announced license agreement with Acumen Pharmaceuticals to develop Alzheimer’s disease drug using JCR’s BBB -penetrating technology platform.</li>
<li>Mesoblast recorded $13.2M revenue from Ryoncil post-launch March 28 through June 30. Sun Pharma launched Leqselvi in the U.S. for the treatment of adults with severe alopecia areata.</li>
</ul>


Shanghai Henlius Biotech initiated Phase 3 U.S. clinical trial for HLX22 for gastroesophageal junction and gastric cancer. CanSino Biologics obtained clinical trial approval in China for polio vaccine.
FDA rejected Nippon Shinyaku’s new drug application for CAP-1002 for DMD. JCR Pharmaceuticals announced license agreement with Acumen Pharmaceuticals to develop Alzheimer’s disease drug using JCR’s BBB -penetrating technology platform.
Mesoblast recorded $13.2M revenue from Ryoncil post-launch March 28 through June 30. Sun Pharma launched Leqselvi in the U.S. for the treatment of adults with severe alopecia areata.


APAC Healthcare Weekly (July 20) – Henlius Bio, CanSino, Nippon Shinyaku, JCR, Mesoblast, Sun Pharma

<ul>
<li>Chugai Pharmaceutical enters inlicensing agreement with Gero to develop novel therapies for age-related diseases. JCR Pharmaceuticals stuck outlicening deal with Alexion for its proprietary JUST-AAV capsids to develop genomic medicines.</li>
<li>Cochlear got FDA approval for new product, which will be launched in 1Q26. CStone Pharmaceuticals entered exclusive partnership with Istituto Gentili to commercialize sugemalimab across Western Europe and UK.</li>
<li>Glenmark signed exclusive licensing agreement with AbbVie for their oncology drug candidate ISB 2001. Lupin entered license and supply agreement for commercialization of its biosimilar Certolizumab Pegol in global markets.</li>
</ul>


Chugai Pharmaceutical enters inlicensing agreement with Gero to develop novel therapies for age-related diseases. JCR Pharmaceuticals stuck outlicening deal with Alexion for its proprietary JUST-AAV capsids to develop genomic medicines.
Cochlear got FDA approval for new product, which will be launched in 1Q26. CStone Pharmaceuticals entered exclusive partnership with Istituto Gentili to commercialize sugemalimab across Western Europe and UK.
Glenmark signed exclusive licensing agreement with AbbVie for their oncology drug candidate ISB 2001. Lupin entered license and supply agreement for commercialization of its biosimilar Certolizumab Pegol in global markets.


APAC Healthcare Weekly (July 13) – Chugai, JCR, Cochlear, CStone, Celltrion, Glenmark, Lupin

<ul>
<li>RemeGen granted exclusive rights to develop and commercialize Telitacicept worldwide (excluding Greater China) to Vor Biopharma for $125M. Innovent Biologics received a first-in-class weight loss drug approval in China.</li>
<li>Daiichi Sankyo received FDA approval for Datroway for the treatment of certain types of non-small cell lung cancer (NSCLC). SanBio now expects Akuugo approval in H2FY26, instead of Q2FY26.</li>
<li>Otsuka in-licensed HBM7020 from Harbour BioMed for an upfront payment of $47M and near-term milestones. Glenmark Pharmaceuticals has launched Beigene’s Tevimbra in India for NSCLC.</li>
</ul>


RemeGen granted exclusive rights to develop and commercialize Telitacicept worldwide (excluding Greater China) to Vor Biopharma for $125M. Innovent Biologics received a first-in-class weight loss drug approval in China.
Daiichi Sankyo received FDA approval for Datroway for the treatment of certain types of non-small cell lung cancer (NSCLC). SanBio now expects Akuugo approval in H2FY26, instead of Q2FY26.
Otsuka in-licensed HBM7020 from Harbour BioMed for an upfront payment of $47M and near-term milestones. Glenmark Pharmaceuticals has launched Beigene’s Tevimbra in India for NSCLC.


APAC Healthcare Weekly (June 29)- RemeGen, Innovent, Daiichi, SanBio, Otsuka, Chugai, Glenmark

<ul>
<li>3SBio entered into an exclusive licensing agreement with Pfizer granting them exclusive license to develop, manufacture, commercialize, and otherwise exploit its breakthrough PD-1/VEGF bispecific antibody SSGJ-707 worldwide excluding mainland China.</li>
<li>CSPC Pharmaceutical Group Limited announced that CPO301, their first-in-class epidermal growth factor receptor (‘‘EGFR’’) antibody drug conjugate (ADC), has been granted the third Fast Track designation by the U.S. FDA.</li>
<li>Samsung Biologics Co. announced that it plans to spin off its biosimilar development business into separate new entity, Samsung Epis Holdings. Samsung Biologics will become a pure-play CDMO.</li>
</ul>


3SBio entered into an exclusive licensing agreement with Pfizer granting them exclusive license to develop, manufacture, commercialize, and otherwise exploit its breakthrough PD-1/VEGF bispecific antibody SSGJ-707 worldwide excluding mainland China.
CSPC Pharmaceutical Group Limited announced that CPO301, their first-in-class epidermal growth factor receptor (‘‘EGFR’’) antibody drug conjugate (ADC), has been granted the third Fast Track designation by the U.S. FDA.
Samsung Biologics Co. announced that it plans to spin off its biosimilar development business into separate new entity, Samsung Epis Holdings. Samsung Biologics will become a pure-play CDMO.


APAC Healthcare Weekly (May 25)- 3SBio, Samsung Biologics, Celltrion, CSPC Pharma, Chugai

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 (Aug 10) – Chugai, Hisamitsu, Wuxi XDC, CSPC Pharma, Junshi Bio, Hanmi Pharma

Obesity treatment related development dominated the week, with Chugai’s drug candidate meeting Phase 3 trial goals, CSPC is a step ahead for...

Tina Banerjee

APAC Healthcare Weekly (July 20) – Henlius Bio, CanSino, Nippon Shinyaku, JCR, Mesoblast, Sun Pharma

Henlius Bio initiates P3 U.S. trial for cancer drug. FDA rejected Nippon Shinyaku’s new drug filing. JCR partners with Acumen to develop...

Tina Banerjee

APAC Healthcare Weekly (July 13) – Chugai, JCR, Cochlear, CStone, Celltrion, Glenmark, Lupin

Chugai entered inlicensing agreement. JCR Pharma and Glenmark stuck outlicensing deal. Cochlear got new product approval. CStone and Lupin found...

Tina Banerjee

APAC Healthcare Weekly (June 29)- RemeGen, Innovent, Daiichi, SanBio, Otsuka, Chugai, Glenmark

Last week couple of Chinese companies signed outlicensing deals with international players. Innovent got weight loss drug approval in China....

Tina Banerjee

APAC Healthcare Weekly (May 25)- 3SBio, Samsung Biologics, Celltrion, CSPC Pharma, Chugai

APAC healthcare companies continued to get approvals for new products and initiates clinical trials. The companies continued with acquisitions and...

Tina Banerjee

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