Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>CSPC Pharmaceutical entered drug discovery collaboration with AstraZeneca in a deal worth of $1.7B+. Abbisko Cayman is collaborating with AstraZeneca to jointly develop a novel IO-TKI combination therapy for NSCLC.</li>
<li>Insilico inked AI drug discovery deal with Takeda Pharmaceutical worth up to $600M. Nippon Shinyaku secured exclusive worldwide rights to develop and commercialize EXG-7001 for DMD from Elixirgen Therapeutics.</li>
<li>Otsuka’s Voyxact demonstrated significant stabilization of kidney function, with evidence of improvement over two years in Phase 3 trial. EMA recommended to pull CSL’s Tavneos from sale in the EU.</li>
</ul>


CSPC Pharmaceutical entered drug discovery collaboration with AstraZeneca in a deal worth of $1.7B+. Abbisko Cayman is collaborating with AstraZeneca to jointly develop a novel IO-TKI combination therapy for NSCLC.
Insilico inked AI drug discovery deal with Takeda Pharmaceutical worth up to $600M. Nippon Shinyaku secured exclusive worldwide rights to develop and commercialize EXG-7001 for DMD from Elixirgen Therapeutics.
Otsuka’s Voyxact demonstrated significant stabilization of kidney function, with evidence of improvement over two years in Phase 3 trial. EMA recommended to pull CSL’s Tavneos from sale in the EU.


APAC Healthcare Weekly (July 5) – CSPC, Abbisko, Insilico, Takeda, Nippon Shinyaku, Otsuka, CSL

<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

<ul>
<li>Shanghai Henlius Biotech announced that PMDA of Japan approved phase 2/3 clinical trial of HLX43 for injection (an anti-PD-L1 antibody-drug conjugate) for advanced squamous non-small cell lung cancer (NSCLC).</li>
<li>Simcere Pharmaceutical announced that, SIM0613 for Injection, an antibody-drug conjugate, received the clinical trial approval in China, and is intended for commencing the clinical trial for advanced solid tumors.</li>
<li>Olympus has signed an exclusive global distribution agreement with EndoRobotics. Under this agreement, robot-assisted technologies manufactured by EndoRobotics will be distributed globally by Olympus exclusively.</li>
</ul>


Shanghai Henlius Biotech announced that PMDA of Japan approved phase 2/3 clinical trial of HLX43 for injection (an anti-PD-L1 antibody-drug conjugate) for advanced squamous non-small cell lung cancer (NSCLC).
Simcere Pharmaceutical announced that, SIM0613 for Injection, an antibody-drug conjugate, received the clinical trial approval in China, and is intended for commencing the clinical trial for advanced solid tumors.
Olympus has signed an exclusive global distribution agreement with EndoRobotics. Under this agreement, robot-assisted technologies manufactured by EndoRobotics will be distributed globally by Olympus exclusively.


APAC Healthcare Weekly (May 10) – Henlius Bio, Simcere, Olympus, Daewoong Pharma

<ul>
<li>Fosun Pharmaceutical received NMPA approval for Phase I/II clinical trial of CAR-T cell drug candidate FKC289. RemeGen received $650M upfront payment from AbbVie under the exclusive license agreement for RC148.</li>
<li>FDA has granted Priority Review to Daiichi Sankyo’s Biologics License Application for ifinatamab deruxtecan. Astellas Pharma initiates Phase 3 registrational study evaluating setidegrasib as first-line treatment for pancreatic ductal adenocarcinoma.</li>
<li>Telix and Regeneron Pharmaceuticals is collaborating to jointly develop and commercialize radiopharmaceutical therapies. Telix will receive upfront cash payment of $40M from Regeneron for access to its radiopharmaceutical manufacturing platform.</li>
</ul>


Fosun Pharmaceutical received NMPA approval for Phase I/II clinical trial of CAR-T cell drug candidate FKC289. RemeGen received $650M upfront payment from AbbVie under the exclusive license agreement for RC148.
FDA has granted Priority Review to Daiichi Sankyo’s Biologics License Application for ifinatamab deruxtecan. Astellas Pharma initiates Phase 3 registrational study evaluating setidegrasib as first-line treatment for pancreatic ductal adenocarcinoma.
Telix and Regeneron Pharmaceuticals is collaborating to jointly develop and commercialize radiopharmaceutical therapies. Telix will receive upfront cash payment of $40M from Regeneron for access to its radiopharmaceutical manufacturing platform.


APAC Healthcare Weekly (April 19) – Fosun Pharma, Remegen, Daiichi Sankyo, Astellas Pharma, Telix

Japan

Daiichi Sankyo Company, Limited is a holding company established through merger of Sankyo and Daiichi pharmaceutical. The Group manufactures pharmaceuticals for human/veterinary use and medical tools and equipment. It also researches and promotes products through related companies throughout the world. The Group also produces food, food additives, livestock feeds, and agrochemicals.

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Daiichi Sankyo (4568 JT)

APAC Healthcare Weekly (July 5) – CSPC, Abbisko, Insilico, Takeda, Nippon Shinyaku, Otsuka, CSL

CSPC, Insilico, and Abiisko inked outlicensing deals with international companies. Nippon Shinyaku inlicenses DMD drug candidate. EMA recommends to...

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

APAC Healthcare Weekly (May 10) – Henlius Bio, Simcere, Olympus, Daewoong Pharma

Henlius Bio and Simcere got trial approval for their respective ADC candidates in Japan and China, respectively. Olympus forges exclusive global...

Tina Banerjee

APAC Healthcare Weekly (April 19) – Fosun Pharma, Remegen, Daiichi Sankyo, Astellas Pharma, Telix

FDA granted Priority Review to Daiichi Sankyo’s I-DXd. Astellas Pharma initiates Phase 3 study for setidegrasib. Telix and Regeneron...

Tina Banerjee

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