Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<ul>
<li>CSPC Pharma got clinical trial approval for the world’s first mRNA-LNP-based dual-target cell therapy product candidate in China. Innovent submitted NDA in China for arcotatug tavatecan for gastroesophageal junction adenocarcinoma.</li>
<li>Shionogi received FDA approval for Xocova, the first and only oral antiviral for post-exposure prophylaxis of COVID‑19. Hanmi Pharm signed $1.2B outlicensing agreement with Eli Lilly for GLP-2 drug candidate.</li>
<li>SK Biosciences has secured first UNICEF procurement contract for influenza vaccine. Lupin secured FDA approval for Lucentis biosimilar, thereby marking the company’s second biosimilar in the U.S.</li>
</ul>


CSPC Pharma got clinical trial approval for the world’s first mRNA-LNP-based dual-target cell therapy product candidate in China. Innovent submitted NDA in China for arcotatug tavatecan for gastroesophageal junction adenocarcinoma.
Shionogi received FDA approval for Xocova, the first and only oral antiviral for post-exposure prophylaxis of COVID‑19. Hanmi Pharm signed $1.2B outlicensing agreement with Eli Lilly for GLP-2 drug candidate.
SK Biosciences has secured first UNICEF procurement contract for influenza vaccine. Lupin secured FDA approval for Lucentis biosimilar, thereby marking the company’s second biosimilar in the U.S.


APAC Healthcare Weekly (June 7) – CSPC Pharma, Innovent, Shionogi, Hanmi Pharm, SK Bioscience, Lupin

<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>Sino Biopharmaceutical’s pan-KRAS inhibitor TQB3205 got clinical trial approval in China for advanced malignant tumors. Jiangsu Hengrui Pharmaceuticals got indication expansion approval for Hetrombopag Olamine Tablets in China.</li>
<li>Astellas Pharma’s Phase3 study investigating Xospata in AML did not meet primary endpoint. Daiichi Sankyo’s indication expansion application for Enhertu has been accepted and granted Priority Review in the U.S.</li>
<li>HK inno.N  signed joint promotion contract with Tanabe Pharma for renal anemia drug Vadanem. CSL announces expansion of manufacturing facility in Illinois to expand its U.S. production presence.</li>
</ul>


Sino Biopharmaceutical’s pan-KRAS inhibitor TQB3205 got clinical trial approval in China for advanced malignant tumors. Jiangsu Hengrui Pharmaceuticals got indication expansion approval for Hetrombopag Olamine Tablets in China.
Astellas Pharma’s Phase3 study investigating Xospata in AML did not meet primary endpoint. Daiichi Sankyo’s indication expansion application for Enhertu has been accepted and granted Priority Review in the U.S.
HK inno.N  signed joint promotion contract with Tanabe Pharma for renal anemia drug Vadanem. CSL announces expansion of manufacturing facility in Illinois to expand its U.S. production presence.


APAC Healthcare Weekly (March 15) – Sino Bio, Hengrui, Astellas, Daiichi Sankyo, HK Inno, CSL

<ul>
<li>Simcere entered outlicensing agreement with Boehringer Ingelheim for IBD drug candidate SIM0709 for upfront payment of €42M. CSPC entered collaboration and license agreement with AstraZeneca for upfront payment of $1.2B.</li>
<li>Hanmi Pharm signs exclusive Mexico distribution deal for GLP-1 obesity drug efpeglenatide. HK inno.N will be launching 'X1 Plus Tablet', a triple antihypertensive drug for the first time in Korea.</li>
<li>Eisai’s Leqembi autoinjector is now under FDA review as weekly starting dose, with target action date of May 24. Chugai Pharmaceutical filed for additional indication of Tecentriq for bladder cancer.</li>
</ul>


Simcere entered outlicensing agreement with Boehringer Ingelheim for IBD drug candidate SIM0709 for upfront payment of €42M. CSPC entered collaboration and license agreement with AstraZeneca for upfront payment of $1.2B.
Hanmi Pharm signs exclusive Mexico distribution deal for GLP-1 obesity drug efpeglenatide. HK inno.N will be launching 'X1 Plus Tablet', a triple antihypertensive drug for the first time in Korea.
Eisai’s Leqembi autoinjector is now under FDA review as weekly starting dose, with target action date of May 24. Chugai Pharmaceutical filed for additional indication of Tecentriq for bladder cancer.


APAC Healthcare Weekly (February 1) – Simcere, CSPC, Hanmi Pharm, HK Inno.N, Eisai, Chugai Pharma

<ul>
<li>Insilico Medicine entered into outlicensing agreement for ISM8969 with Hygtia Therapeutics for upfront and milestone payment of $66M. Daiichi Sankyo’s Enhertu got its sixth indication approval in China.</li>
<li>Shionogi will pick up Pfizer’s 11.7% stake in HIV-focused ViiV Healthcare for $2.1B. Alteogen signed an exclusive license agreement with GSK’s subsidiary Tesaro for ALT-B4 for upfront payment of $20M.</li>
<li>HK inno.N completes enrolment for Phase 3 clinical trial for its once-weekly GLP-1 obesity drug candidate, IN-B00009. Sun Pharmaceutical has received approval for generic version of semaglutide injection in India.</li>
</ul>


Insilico Medicine entered into outlicensing agreement for ISM8969 with Hygtia Therapeutics for upfront and milestone payment of $66M. Daiichi Sankyo’s Enhertu got its sixth indication approval in China.
Shionogi will pick up Pfizer’s 11.7% stake in HIV-focused ViiV Healthcare for $2.1B. Alteogen signed an exclusive license agreement with GSK’s subsidiary Tesaro for ALT-B4 for upfront payment of $20M.
HK inno.N completes enrolment for Phase 3 clinical trial for its once-weekly GLP-1 obesity drug candidate, IN-B00009. Sun Pharmaceutical has received approval for generic version of semaglutide injection in India.


APAC Healthcare Weekly (January 25) – InSilico, Daiichi, Shionogi, Alteogen, HK Inno, Sun Pharma

South Korea

HK inno.N Corp. develops and manufactures pharmaceuticals products. The Company develops and sells immune anticancer drugs, blood disease drugs, kidney disease drugs, and other products. HK inno.N conducts businesses across worldwide.

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HK inno.N (195940 KS)

APAC Healthcare Weekly (June 7) – CSPC Pharma, Innovent, Shionogi, Hanmi Pharm, SK Bioscience, Lupin

Innovent submitted NDA for oncology drug. Shionogi got FDA approval for Xocova. Hanmi Pharm signed $1.2B outlicensing deal with Lilly. SK...

Tina Banerjee

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

Sino Bio got fourth indication approval for Benmelstobart plus Anlotinib. Wuxi Biologics’ three facilities got Korean GMP certification. FDA...

Tina Banerjee

APAC Healthcare Weekly (March 15) – Sino Bio, Hengrui, Astellas, Daiichi Sankyo, HK Inno, CSL

Couple of Chinese companies got clinical trials approvals for their respective drug candidates. Astellas’ Phase 3 trial failed to meet primary...

Tina Banerjee

APAC Healthcare Weekly (February 1) – Simcere, CSPC, Hanmi Pharm, HK Inno.N, Eisai, Chugai Pharma

CSPC and Simcere signed outlicensing deals with AstraZeneca and Boehringer Ingelheim, respectively. Eisai’s Leqembi autoinjector is now under FDA...

Tina Banerjee

APAC Healthcare Weekly (January 25) – InSilico, Daiichi, Shionogi, Alteogen, HK Inno, Sun Pharma

InSilico entered outlicensing deal. Daiichi’s Enhertu got China approval for 6th indication. Shionogi will pick up Pfizer’s stake in ViiV...

Tina Banerjee

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