Research Coverage of Japanese Listed Companies, Shared Research Inc

Shared Research

Research Coverage of Japanese Listed Companies

Shared Research Inc

Pioneering research coverage of Japanese listed companies. Now customizable and interactive for global institutional investors. Corporate access reimagined.

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<ul><li>Revenue decreased by JPY135mn to JPY21.8bn due to smaller milestone payments, partially offset by Quviviq sales.</li><li>R&D expenses rose 31.5% YoY to JPY11.2bn, driven by increased investment and a weaker yen, mainly in the UK.</li><li>Core operating loss was JPY986mn, compared to a JPY4.4bn profit in cumulative Q3 FY12/24, reflecting non-cash expenses.</li></ul>

Revenue decreased by JPY135mn to JPY21.8bn due to smaller milestone payments, partially offset by Quviviq sales.R&D expenses rose 31.5% YoY to JPY11.2bn, driven by increased investment and a weaker yen, mainly in the UK.Core operating loss was JPY986mn, compared to a JPY4.4bn profit in cumulative Q3 FY12/24, reflecting non-cash expenses.

Sosei Group (4565 JP): Q3 FY12/25 flash update

Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>CSPC Pharmaceutical’s Phase 3 trial of depression drug candidate HA1406 met pre-specified primary efficacy endpoint. Jiangsu Hengrui Pharmaceuticals received NMPA approval for long-acting basal insulin, sudelidec injection.</li>
<li>Otsuka Holdings secured FDA approval for Simtriyo, a once-daily extended-release capsule for ADHD. Nippon Shinyaku obtained exclusive commercialization rights for Tadekinig alfa in the U.S. for Hyperinflammatory Syndrome.</li>
<li>Pharmaessentia announced topline results from the Phase 1b clinical trial of P1101 (Besremi) and anti-PD1 in Chronic Hepatitis B or D. Cipla secured FDA approval for generic Advair Diskus.</li>
</ul>


CSPC Pharmaceutical’s Phase 3 trial of depression drug candidate HA1406 met pre-specified primary efficacy endpoint. Jiangsu Hengrui Pharmaceuticals received NMPA approval for long-acting basal insulin, sudelidec injection.
Otsuka Holdings secured FDA approval for Simtriyo, a once-daily extended-release capsule for ADHD. Nippon Shinyaku obtained exclusive commercialization rights for Tadekinig alfa in the U.S. for Hyperinflammatory Syndrome.
Pharmaessentia announced topline results from the Phase 1b clinical trial of P1101 (Besremi) and anti-PD1 in Chronic Hepatitis B or D. Cipla secured FDA approval for generic Advair Diskus.


APAC Healthcare Weekly (August 2) – CSPC, Hengrui, Otsuka, Nippon Shinyaku, PharmaEssnetia, Cipla

<ul>
<li>Sino Biopharmaceutical received approval for Benmelstobart plus Anlotinib for alveolar soft part sarcoma in China. Wuxi Biologics announced that three of its manufacturing facilities received GMP certification from South Korea.</li>
<li>Astellas Pharma has been granted Priority Review status by the FDA for indication expansion application for Padcev. Eisai’s Phase 3 trial evaluating Lenvima in RCC did not meet primary endpoints.</li>
<li>Celltrion started patient dosing for three of its novel ADC-based anticancer drug candidates. Cochlear has reduced FY26 underlying net profit guidance to A$290–330M from A$435–460M.</li>
</ul>


Sino Biopharmaceutical received approval for Benmelstobart plus Anlotinib for alveolar soft part sarcoma in China. Wuxi Biologics announced that three of its manufacturing facilities received GMP certification from South Korea.
Astellas Pharma has been granted Priority Review status by the FDA for indication expansion application for Padcev. Eisai’s Phase 3 trial evaluating Lenvima in RCC did not meet primary endpoints.
Celltrion started patient dosing for three of its novel ADC-based anticancer drug candidates. Cochlear has reduced FY26 underlying net profit guidance to A$290–330M from A$435–460M.


APAC Healthcare Weekly (April 26) – Sino Bio, Wuxi Bio, Astellas Pharma, Eisai, Celltrion, Cochlear

<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

<ul>
<li>Innovent Biologics entered a strategic collaboration with Eli Lilly, to advance novel medicines in oncology and immunology. InSilico and China Medical System Holdings stuck partnership on innovative drug development.</li>
<li>Eisai’s Leqembi subcutaneous autoinjector gets priority review in China. FDA accepted Takeda’s NDA for oveporexton for the treatment of narcolepsy type 1, with a decision date in 3Q26.</li>
<li>Alteogen’s once-monthly obesity treatment candidate matches weight loss effects of Eli Lilly's once-weekly retatrutide, currently under development. Pharmaessentia plans to invest $46M to establish a manufacturing subsidiary in Puerto Rico.</li>
</ul>


Innovent Biologics entered a strategic collaboration with Eli Lilly, to advance novel medicines in oncology and immunology. InSilico and China Medical System Holdings stuck partnership on innovative drug development.
Eisai’s Leqembi subcutaneous autoinjector gets priority review in China. FDA accepted Takeda’s NDA for oveporexton for the treatment of narcolepsy type 1, with a decision date in 3Q26.
Alteogen’s once-monthly obesity treatment candidate matches weight loss effects of Eli Lilly's once-weekly retatrutide, currently under development. Pharmaessentia plans to invest $46M to establish a manufacturing subsidiary in Puerto Rico.


APAC Healthcare Weekly (February 15)–Innovent Bio, InSilico, Eisai, Takeda, Alteogen, Pharmaessentia

Japan

Sosei Group Corporation is a holding company which was established through reorganization.  The Group companies are biopharmaceutical companies specializing in drug development.  Sosei Group enters into license agreements primarily with US, EU, and Japanese companies to market the licensed drugs in Japan and find alternative usage on such drugs.

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Sosei Group (4565 JP)