Global Healthcare Analyst

Tina Banerjee

Thematic (Sector/Industry)

<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>Celltrion inlicensed two antibody-based new drug candidates for the treatment of autoimmune diseases in KRW1T deal. Dong-A ST received approval for epilepsy drug, Xcopri, developed by SK Biopharmaceuticals in Korea.</li>
<li>Hanmi Pharmaceutical will distribute and sell three major COPD treatments developed by Boehringer Ingelheim. Shandong Boan Biotechnology’s marketing application for denosumab biosimilar has been accepted in the UK.  </li>
<li>Eisai has settled patent infringement litigation with Torrent Pharmaceuticals related to Lenvima in the U.S. Otsuka Holdings initiated Phase 3 clinical trial evaluating quabodepistat, for the treatment of multidrug-resistant tuberculosis.</li>
</ul>


Celltrion inlicensed two antibody-based new drug candidates for the treatment of autoimmune diseases in KRW1T deal. Dong-A ST received approval for epilepsy drug, Xcopri, developed by SK Biopharmaceuticals in Korea.
Hanmi Pharmaceutical will distribute and sell three major COPD treatments developed by Boehringer Ingelheim. Shandong Boan Biotechnology’s marketing application for denosumab biosimilar has been accepted in the UK.  
Eisai has settled patent infringement litigation with Torrent Pharmaceuticals related to Lenvima in the U.S. Otsuka Holdings initiated Phase 3 clinical trial evaluating quabodepistat, for the treatment of multidrug-resistant tuberculosis.


APAC Healthcare Weekly (November 9) – Celltrion, Dong-A ST, Hanmi Pharm, Boan Bio, Eisai, Otsuka

<ul>
<li>Takeda has dropped AstraZeneca-partnered antibody drug candidate from its pipeline. Eisai and Merck are closing late-stage trial of Lenvima plus Keytruda in hepatocellular carcinoma on disappointing result.</li>
<li>Wuxi AppTec sharpens CRDMO business by selling its China-based clinical research subsidiaries. FDA has designated Celltrion’s Stoboclo and Osenvelt as interchangeable biosimilars to the reference products Prolia and Xgeva, respectively.</li>
<li>CSL is delaying demerger of CSL Seqirus ‘to maximise shareholder value.’ PharmaEssentia has filed for the additional indication of Besremi for Essential Thrombocythemia (ET) with the FDA.</li>
</ul>


Takeda has dropped AstraZeneca-partnered antibody drug candidate from its pipeline. Eisai and Merck are closing late-stage trial of Lenvima plus Keytruda in hepatocellular carcinoma on disappointing result.
Wuxi AppTec sharpens CRDMO business by selling its China-based clinical research subsidiaries. FDA has designated Celltrion’s Stoboclo and Osenvelt as interchangeable biosimilars to the reference products Prolia and Xgeva, respectively.
CSL is delaying demerger of CSL Seqirus ‘to maximise shareholder value.’ PharmaEssentia has filed for the additional indication of Besremi for Essential Thrombocythemia (ET) with the FDA.


APAC Healthcare Weekly (November 2) – Takeda, Eisai, Wuxi AppTec, Celltrion, CSL, PharmaEssentia

<ul>
<li>Daiichi Sankyo’s indication expansion application for Enhertu has been accepted for review by FDA for certain types of breast cancers. Santen’s new drug application has been accepted in China.  </li>
<li>Hanmi Pharm entered into a global licensing agreement with Gilead Sciences granting Gilead the exclusive rights to develop and commercialize encequidar. Boryung is acquiring Sanofi’s cytotoxic anti-cancer drug Taxotere.</li>
<li>IHH Healthcare received SEBI approval for mandatory open offer for 26% stake in Fortis Healthcare. Lupin has launched Liraglutide prefilled pen, bioequivalent to Victoza, in the U.S.</li>
</ul>


Daiichi Sankyo’s indication expansion application for Enhertu has been accepted for review by FDA for certain types of breast cancers. Santen’s new drug application has been accepted in China.  
Hanmi Pharm entered into a global licensing agreement with Gilead Sciences granting Gilead the exclusive rights to develop and commercialize encequidar. Boryung is acquiring Sanofi’s cytotoxic anti-cancer drug Taxotere.
IHH Healthcare received SEBI approval for mandatory open offer for 26% stake in Fortis Healthcare. Lupin has launched Liraglutide prefilled pen, bioequivalent to Victoza, in the U.S.


APAC Healthcare Weekly (October 5) – Daiichi Sankyo, Santen, Hanmi Pharm, Boryung, IHH Health, Lupin

<ul>
<li>Fosun Pharma received approval for Fovinaciclib Citrate Capsules for certain types of breast cancers. Chugai’s oral GLP-1 drug candidate demonstrated semaglutide-beating result in Phase 3 trial being conducted by Lilly.</li>
<li>Astellas Pharma got conditional approval of Izervay in Japan. SK Biopharmaceuticals announced positive result from Phase 3 trial evaluating cenobamate for Primary Generalized Tonic-Clonic (PGTC) Seizures.</li>
<li>Alteogen’s partner Merck moved one step ahead toward European approval of subcutaneous version of Keytruda. HK inno.N has launched its acid-related gastrointestinal diseases drug, PCAB in India.</li>
</ul>


Fosun Pharma received approval for Fovinaciclib Citrate Capsules for certain types of breast cancers. Chugai’s oral GLP-1 drug candidate demonstrated semaglutide-beating result in Phase 3 trial being conducted by Lilly.
Astellas Pharma got conditional approval of Izervay in Japan. SK Biopharmaceuticals announced positive result from Phase 3 trial evaluating cenobamate for Primary Generalized Tonic-Clonic (PGTC) Seizures.
Alteogen’s partner Merck moved one step ahead toward European approval of subcutaneous version of Keytruda. HK inno.N has launched its acid-related gastrointestinal diseases drug, PCAB in India.


APAC Healthcare Weekly (September 21)– Fosun Pharm, Chugai, Astellas, SK Biopharm, Alteogen, HK Inno

South Korea

SK Biopharmaceuticals Co., Ltd. researches and develops new drugs. The Company develops and markets brain disorders treatment drugs, central nervous system disorders treatment drugs, and other products. SK Biopharmaceuticals markets its products worldwide.

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SK Biopharmaceuticals (326030 KS)

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 9) – Celltrion, Dong-A ST, Hanmi Pharm, Boan Bio, Eisai, Otsuka

Celltrion inlicensed two antibody drug candidates in KRW1T deal. Dong-A got domestic approval for Xcopri. Hanmi Pharm will distribute Boehringer...

Tina Banerjee

APAC Healthcare Weekly (November 2) – Takeda, Eisai, Wuxi AppTec, Celltrion, CSL, PharmaEssentia

Takeda and Eisai witnessed clinical trials setback. Wuxi AppTec is selling China-based CRO subsidiaries. CSL is delaying demerger of CSL Seqirus....

Tina Banerjee

APAC Healthcare Weekly (October 5) – Daiichi Sankyo, Santen, Hanmi Pharm, Boryung, IHH Health, Lupin

Daiichi Sankyo’s label expansion application for Enhertu has been accepted by FDA. Hanmi Pharm entered into global licensing agreement with Gilead...

Tina Banerjee

APAC Healthcare Weekly (September 21)– Fosun Pharm, Chugai, Astellas, SK Biopharm, Alteogen, HK Inno

Fosun Pharma and Astellas got new drug approvals. Chugai and SK Biopharma announced positive Phase 3 trial result. Alteogen’s technology powered...

Tina Banerjee

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