Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<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

<ul>
<li>Sichuan Kelun-Biotech announces Phase 3 trial success for ADC-Keytruda combination therapy in first-line lung cancer. ImmuneOnco received Phase 3 trial approval for IMM0306 lenalidomide combination for follicular lymphoma in China.</li>
<li>Otsuka received FDA accelerated approval of Voyxact for immunoglobulin A nephropathy. Eisai has completed FDA submission of Leqembi Iqlik subcutaneous autoinjector as a weekly starting dose for early Alzheimer’s disease.</li>
<li>Alteogen secures $15M milestone payment from Merck as Keytruda subcutaneous formulation gets EU approval. SK Biopharmaceuticals in-licenses second radiopharmaceutical candidate, which has potential to target clear cell renal cell carcinoma.  </li>
</ul>


Sichuan Kelun-Biotech announces Phase 3 trial success for ADC-Keytruda combination therapy in first-line lung cancer. ImmuneOnco received Phase 3 trial approval for IMM0306 lenalidomide combination for follicular lymphoma in China.
Otsuka received FDA accelerated approval of Voyxact for immunoglobulin A nephropathy. Eisai has completed FDA submission of Leqembi Iqlik subcutaneous autoinjector as a weekly starting dose for early Alzheimer’s disease.
Alteogen secures $15M milestone payment from Merck as Keytruda subcutaneous formulation gets EU approval. SK Biopharmaceuticals in-licenses second radiopharmaceutical candidate, which has potential to target clear cell renal cell carcinoma.  


APAC Healthcare Weekly (November 30) – Kelun Bio, ImmuneOnco, Otsuka, Eisai, Alteogen, SK Biopharma

<ul>
<li>3SBio will spin-off and separately list the shares of Mandi, a subsidiary of the company. Celltrion got EC approval for Remsima IV liquid, world’s first liquid formulation of IV infliximab.</li>
<li>Hanmi Pharmaceutical is acquiring all of the issued and outstanding common shares of Aptose Biosciences that are not currently owned or controlled by Hanmi.</li>
<li>Otsuka got CHMP positive opinion for donidalorsen for the prevention of recurrent attacks of HAE. CSL plans to expand U.S. presence over the next five years, with ~$1.5B U.S. capex.</li>
</ul>


3SBio will spin-off and separately list the shares of Mandi, a subsidiary of the company. Celltrion got EC approval for Remsima IV liquid, world’s first liquid formulation of IV infliximab.
Hanmi Pharmaceutical is acquiring all of the issued and outstanding common shares of Aptose Biosciences that are not currently owned or controlled by Hanmi.
Otsuka got CHMP positive opinion for donidalorsen for the prevention of recurrent attacks of HAE. CSL plans to expand U.S. presence over the next five years, with ~$1.5B U.S. capex.


APAC Healthcare Weekly (November 23) – 3SBio, Celltrion, Hanmi Pharm, HK Inno.N, Otsuka, CSL

<ul>
<li>Leads Biolabs initiated Phase 2 clinical study evaluating LBL-024 for the first-line treatment of HCC. Henlius Biotech got FDA approval for Poherdy, as the first interchangeable biosimilar to Roche’s Perjeta.</li>
<li>Otsuka announced positive Phase 3 interim analysis of sibeprenlimab for immunoglobulin A nephropathy. ABL Bio signed technology transfer and joint R&amp;D agreement with Eli Lilly for upfront payment of $40M.</li>
<li>Boryung Pharmaceutical began construction to double its oral penicillin production capacity. Eubiologics published positive result from Phase 3 clinical trial evaluating EuTYPH-C, a typhoid conjugate vaccine.</li>
</ul>


Leads Biolabs initiated Phase 2 clinical study evaluating LBL-024 for the first-line treatment of HCC. Henlius Biotech got FDA approval for Poherdy, as the first interchangeable biosimilar to Roche’s Perjeta.
Otsuka announced positive Phase 3 interim analysis of sibeprenlimab for immunoglobulin A nephropathy. ABL Bio signed technology transfer and joint R&amp;D agreement with Eli Lilly for upfront payment of $40M.
Boryung Pharmaceutical began construction to double its oral penicillin production capacity. Eubiologics published positive result from Phase 3 clinical trial evaluating EuTYPH-C, a typhoid conjugate vaccine.


APAC Healthcare Weekly (November 16) – Leads Bio, Henlius Bio, Otsuka, ABL Bio, Boryung, Eubiologics

Japan

Otsuka Holdings Co Ltd is a pharmaceutical company. The Company manufactures, sells, imports and exports pharmaceutical products, clinical testing, and medical equipment for intractable diseases.

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Otsuka Holdings (4578 JT)

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

APAC Healthcare Weekly (November 30) – Kelun Bio, ImmuneOnco, Otsuka, Eisai, Alteogen, SK Biopharma

Kelun Bio announces Phase 3 trial success for ADC-Keytruda combo in first-line lung cancer. Otsuka got FDA approval for IgAN drug. Alteogen secures...

Tina Banerjee

APAC Healthcare Weekly (November 23) – 3SBio, Celltrion, Hanmi Pharm, HK Inno.N, Otsuka, CSL

3SBio will spin-off and separately list its subsidiary. Celltrion got EC approval for Remsima IV liquid. Hanmi Pharm is acquiring Aptose...

Tina Banerjee

APAC Healthcare Weekly (November 16) – Leads Bio, Henlius Bio, Otsuka, ABL Bio, Boryung, Eubiologics

Henlius got FDA approval for Perjeta biosimilar. Otsuka reports positive Phase 3 trial result for sibepernlimab. ABL Bio signed deal with Lilly....

Tina Banerjee

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