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- 2026-05-08 22:44:25
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- Pfizer’s NSCLC drug Vizimpro to be prescribed at GHs
- by Eo, Yun-Ho Dec 14, 2021 05:57am
- Pfizer’s EGFR TKI Vizimpro may now be prescribed at general hospitals. According to industry sources, Pfizer Korea’s Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) Vizimpro (dacomitinib) passed the Drug Committees (DCs) of four of the Big-5s - Samsung Medical Center (SMC), Seoul National University Hospital (SNUH), Seoul St. Mary’s Hospital, Asan Medical Center (AMC) – and many other major medical institutions including the National Cancer Center, Seoul National University Bundang Hospital, Pusan National University Hospital, Chungbuk National University Hospital, and Chungnam National University Hospital, etc. Vizimpro, which was listed for reimbursement in Korea in December last year, was granted priority review by the US FDA in January 2018 and approved in September of the same year. The drug is currently approved in the US, EU, and Japan among other countries. In Korea, Vizimpro was approved as a first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC). The drug is indicated to treat EGFR-positive advanced NSCLC patients diagnosed with exon 19 deletion or exon 21 L858R substitution mutations. Currently, 1st generation EGFR TKIs AstraZeneca’s Iressa (gefitinib) and AstraZeneca’s Iressa (gefitinib); 2nd generation EGFR TKI Giotrif (afatinib); and 3rd generation EGFR TKI AstraZeneca’s Tagrisso (osimertinib) are being prescribed in Korea. Among these drugs, competition between Vizimpro and the other 2nd generation EGFR TKI Giotrif for prescriptions is expected to intensify. Vizimpro’s efficacy was demonstrated through the Phase III ARCHER 1050 study. The study directly compared Vizimpro with Iressa (gefitinib) and registered a total of 452 NSCLC patients. Results showed that by progression-free survival, (PFS) Vizimpro reduced the hazard ratio by 41% compared to Iressa, and the median PFS of Vizimpro was 14.7 months, an improvement to the 9.2 months in the Gefitinib group.
- Company
- Sang Wook Kang, CEO of GSK consumer healthcare, resigned
- by Eo, Yun-Ho Dec 14, 2021 05:57am
- The CEO of GSK and Novartis' OTC joint venture "GSK Consumer Healthcare" is expected to be replaced. According to related industries, Kang Sang-wook (45) CEO of GSK Consumer Healthcare Korea recently resigned. As a result, CEO Kang will leave the company about three years after taking office in January 2019. He entered the pharmaceutical industry through BAT Korea and L'Oreal Korea. The exact reason for resignation is unknown, and it has been confirmed that Kang's successor has not yet. For the time being, GSK Consumer Healthcare will be operated as a temporary representative system. Meanwhile, GSK Consumer Healthcare was launched in 2015 as a Novartis joint venture as a company that sells items such as GSK's OTC and consumer goods. Since then, it has maintained its corporation so far after integrating the US pharmaceutical company Pfizer and Consumer Healthcare business in 2018. The company is selling more than 50 products in Korea, including oral care brands such as Sensodyne, Parodontax, and Polydent, as well as OTC and medical device brands such as Theraflu and Otrivin.
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- Boehringer loses another ‘Trajenta’ trademark dispute
- by Kim, Jin-Gu Dec 13, 2021 05:57am
- Boehringer Ingelheim once again tasted defeat in a trademark dispute over its DPP-4 inhibitor antidiabetic ‘Trajenta (linagliptin).' In addition to the trademark dispute against Kwangdong Pharmaceutical in 2019, the company recently lost once more in a suit against Daewoong Pharmaceutical. According to the industry on the 13th, the Intellectual Property Trial and Appeal Board dismissed the trademark invalidation trial field by Boehringer Ingelheim against Daewoong Pharmaceutical. Boehringer Ingelheim had filed a trademark invalidation trial against Daewoong Pharmaceutical claiming that Daewoong’s ‘Traceta’ is similar to Trajenta. Traceta is an Acetaminophen and Tramadol combination used to treat acute and chronic pain. The drug was approved in October 2019. In June 2019, four months before gaining approval, the company had filed a trademark application for the trade name Traceta and registered the trademark in October 2019, immediately after the drug approval. On Boehringer Ingelheim’s claim of trademark infringement, Daewoong Pharmaceutical rebutted that the antidiabetic Trajenta and the analgesic Traceta have very different uses, and therefore have little risk of causing misunderstanding or confusion among general consumers. As a result, the IPTAB ruled in favor of Daewoong Pharmaceutical. This was the second trademark dispute defeat for Boehringer Ingelheim in Korea. The company had filed a similar trademark invalidation suit against Kwangdong Pharmaceutical in July 2019 but lost. At the time, Boehringer Ingelheim claimed the trademark of Kwangdong’s ‘Diagenta’ invalid due to their similar name and class of goods. Diagenta is a generic of Trajenta made by Kwangdong Pharmaceutical that was approved in February 2019. 24 companies including Kwangdong Pharmaceutical had received approval for their generics by succeeding in invalidating the crystalline form patent of Trajenta at the time, but Boehringer Ingelheim had only requested an invalidation trial against Kwangdong Pharmaceutical. The IPTAB said, “Trajenta is a coined trademark with no special meaning. Diagenta’s name nor appearance is similar to Trajenta and the contrast is clear in concept. Although both names contain ‘genta’, the difference between the first two letters is large, leaving little room for consumers to misunderstand or confuse them.” Trajenta is Boehringer Ingelheim’s DPP-4 inhibitor used to treat diabetes. According to the market research institution UBIST, prescription sales of Trajenta amounted to 64.5 billion won last year. The drug was prescribed 47.2 billion won’s worth by Q3 this year. Trajenta Duo, a Trajenta+metformin combination of Boehringer Ingelheim, sold an accumulated amount of 49.9 billion won by Q3 this year. 19 companies including Sinil Pharmaceutical had received generic exclusivity for Trajenta’s generic through a crystalline form invalidation patent and passive trials to confirm the scope of composition patent in 2016. The companies may release their generics after September 2023 when Trajenta’s substance patent and use patent expires.
- Company
- Ildong Idience’s Venadaparib IND approved in China
- by Kim, Jin-Gu Dec 13, 2021 05:56am
- On the 10th, Ildong Holding’s new drug development subsidiary Idience announced that its IND(Investigational New Drug) application for ‘Venadaparib (IDX-1197)’ for gastric cancer patients was approved by China’s National Medical Products Administration. Venadaparib, a PARP (ADP-ribose polymerase) inhibitor, is a new targeted therapy candidate that is being developed to target breast cancer, ovarian cancer, gastric cancer, and PARP inhibitor-resistant cancers. Idience plans to evaluate the safety and efficacy of Venadaparib in combination with irinotecan, an established anticancer drug, on gastric cancer patients in China as soon as all the requirements are met. Idience is in clinical trials with Venadaparib in Korea and the US after receiving approval for its IND application from Korea’s Ministry of Food and Drug Safety and the US Food and Drug Administration. The company had presented results that demonstrate the efficacy of Venadaparib in PARP inhibitor-resistant cancer and BRCA mutation-negative cancer at academic conferences held this year by the American Association for Cancer Research (AACR), American Society of Clinical Oncology (ASCO), and the European Society for Medical Oncology (ESMO). An official from Idience said, “The high incidence of gastric cancer and relatively high number of patients in China make the country advantageous for clinical trials. The IND approval in China will allow us to speed up the development and commercialization of Venadaparib.” He added, “We will also continue research to confirm the effectiveness of Venadaparib and present our development progress, research results, and differentiated strengths of the drug at academic meetings and conferences overseas”
- Company
- GC Pharma, stopped discussing consignment of Janssen vaccine
- by Kim, Jin-Gu Dec 13, 2021 05:56am
- GC Pharma announced on the 9th that it will suspend discussions on Janssen's consignment production of the COVID-19 vaccine. GC Pharma said it has suspended discussions with Johnson & Johnson on consignment production of vaccines as of today (9th). It has been about four months since GC Pharma announced in August that it will produce Janssen's COVID-19 vaccine on consignment. At the time, a local media reported that GC Pharma was discussing consignment production of COVID-19 vaccines with Janssen. At that time, GC Pharma made an official position that "it has not been confirmed." The pharmaceutical bio industry expected that if GC Pharma signs a consignment production contract with Janssen, it will be the third case of domestic production of the global corona vaccine after SK Bioscience-AstraZeneca and Samsung Biologics-Moderna. Janssen's COVID-19 vaccine was approved in Korea in April. One vaccination has a preventive effect. The preventive effect is 66.9%. However, it is known that the preventive effect decreases sharply over time after inoculation.
- Company
- PH3s of Daewoong’s SGLT-2i antidiabetic near completion
- by Kim, Jin-Gu Dec 10, 2021 05:53am
- #1i Clinical trials for the new antidiabetic SGLT-2 inhibitor ‘Enavogliflozin’ in development by Daewoong Pharmaceutical are gaining speed. One of the three Phase III clinical trials is already complete, and the remaining two are also nearing their final stages after completing patient recruitment. With such progress, the industry expects the authorities to grant marketing authorization for Enavogliflozin within the first half of next year, then be released in 2023. ◆Phase III trial on two-drug combo complete… trials on monotherapy and three-drug combo also in final stages According to the industry on the 10th, Daewoong Pharmaceutical had recently completed the Phase III trial for its Enavogliflozin(DWP16001)+metformin combination therapy. Enavogliflozin, a new SGLT-2 inhibitor antidiabetic, is the first SGLTi developed by a domestic pharmaceutical company. Other antidiabetic SGLTi options available include AstraZeneca’s ‘Forxiga,’ Boehringer Ingelheim’s ‘Jardiance,’ Astellas’ ‘Suglat,’ MSD’s ‘Steglatro,’ among others. Last year, Daewoong Pharmaceutical had received approval to initiate a Phase III clinical trial on 190 patients with type 2 diabetes in 24 hospitals in Korea, including Seoul Saint Mary’s hospital, to assess the efficacy of its Enavogliflozin+metformin combination therapy. After registering the last patient in May this year, the company completed observations on the last patient in November and is currently analyzing clinical data. The company had initially expected to complete the trial by December 2023, but due to smooth progress, the end date was pulled forward by a year. Other clinical trials on Enavogliflozin are also in smooth progress. Daewoong Pharmaceutical is currently running 3 trials related to Enavogliflozin. In addition to its two-drug combination trial on Enavogliflozin+metformin, the company is also assessing Enavogliflozin as a monotherapy and a three-drug combination that uses metformin and DDP-4 inhibitor in addition to Enavogliflozin. Among these, the Phase III trial on the Enavogliflozin monotherapy has started in September last year on 140 patients in Korea. Patient recruitment is now complete and observation of the last patient is expected to be completed within this year at the earliest. The patient recruitment for the three-drug combo has also been completed. Daewoong Pharmaceuticals had received approval to initiate a Phase III trial to assess the efficacy of the Enavogliflozin+metformin+DPP-4 inhibitor combination on 256 patients last October. LG Chem’s gemigliptin was selected as the DPP-4 inhibitor for the three-drug combo, and patient recruitment was completed in August this year. With all three Phase III trials coming to an end, prospects on when the drug will be authorized have also been rising. The pharmaceutical industry believes that it is strongly likely that the company will apply for marketing authorization next year and release the drug in 2023. Daewoong Pharmaceutical had originally planned to release its drug in 2023. The pharmaceutical industry believes that there is a strong possibility that the company will apply for product approval in the first half of next year and release it in 2023. Daewoong Pharmaceutical had originally planned to release it in 2023. ◆ Extension studies for data acquisition also in smooth progress… started trials to enter global market For the Enavogliflozin monotherapy and the two-drug combination using metformin, an extension (long-term administration) trial is also underway in addition to the Phase III trial. Trials on long-term administration of drugs are usually conducted after the product is released, but Daewoong Pharmaceutical plans to release the drug after securing relevant data. The company’s move to first secure the long-term clinical data is interpreted as a strategic attempt to compete with existing SGLT-2 inhibitors. The extension trial for the Enavogliflozin monotherapy was approved in August this year. The clinical trial size is 70. The company started the trial in full by starting recruitment in September last year. The extension trial for the two-drug combination therapy using metformin was approved in March this year, and the company had succeeded in recruiting all 100 patients in November. The trial is expected to be completed by the first half of next year. With existing Enavogliflozin trials entering completion, the company has also been initiating new trials. The company had started a Phase I trial targeting Koreans, Westerners, and Latin American patients on December 1st. It is explained that the trial was prepared with global expansion in mind. The company is also actively seeking indication extensions. In August this year, the company had received approval to initiate a Phase I trial for DWP30600. DWP30600 is a combination of Enavogliflozin and an anorectic agent (DWC202010).
- Company
- ₩150 bil export of Celltrion’s Regkirona on track to
- by Kim, Jin-Gu Dec 10, 2021 05:51am
- Export of Celltrion’s COVID-19 antibody treatment ‘Regkirona (regdanvimab)’ is now fully on track. On the 9th, Celltrion Healthcare announced that it had completed shipping 150,000 vials of the initial load of Regkirona for 9 countries in Europe. Celltrion Healthcare has been discussing exporting Regkirona with 70 countries. In addition to the 9 countries that the company is supplying its initial load to, the company has signed supply agreements with a total of 18 countries. The total amount that has been and will be supplied in December alone is expected to reach ₩150 billion. Demand for the supply of Regkirona has been increasing due to the increased product reliability following the European Commission's (EC) marketing approval and the rapid increase in the number of confirmed COVID-19 cases. Celltrion Healthcare plans to supply the maximum amount this year through close cooperation with Celltrion, which is in charge of production. Regkirona received official marketing authorization in Korea and Europe. Also, the drug received conditional approval or emergency use authorization in other countries including Australia, Indonesia, Brazil, and Peru. Celltrion Healthcare said that the company is expanding discussions to sign new agreements with these countries. As a result, the industry experts expect the company to supply more Regkirona next year compared to this year. An official from Celltrion Healthcare said, “With additional approvals continuing around the world following the EC approval, we plan to continue to increase making supply agreements. In addition to Regkirona, the Celltrion group will continue to contribute to overcoming the global COVID-19 pandemic by developing innovative solutions such as CT-P63 to tackle new variants and inhalable forms of treatment.
- Company
- Signifor Lar discontinued in the lacking acromegaly Tx mkt
- by Eo, Yun-Ho Dec 09, 2021 05:59am
- A considerable blow is expected in the already lacking acromegaly treatment market with the discontinuation of one of its very few available options. According to industry sources, the domestic supply of the acromegaly treatment ‘Signifor LAR (pasireotide)’ has been discontinued. The decision was made as Novartis sold the rights to Signifor La to Recordati SpA.,an Italian pharmaceutical company. As a result, the drug that had been developed by Novartis and distributed by Samoh Pharm will now be discontinued in Korea. However, the problem lies in the patients. Signifor LAR is a second-line treatment for acromegaly that was listed for reimbursement in November 2017. At the time, Signifor LAR was the only second-line treatment option available in the market. However, Pfizer’s ‘Somavert (pegvisomant)’ was listed in September, adding one more option as a second-line treatment. The discontinuation in its supply would most greatly affect those who are currently receiving Signifor LAR. As a rare disease treatment, around 10 patients in Korea have been using Signifor LAR, but they may experience insurance cuts if they switch to Somavert due to unclear reimbursement standards. And the patients cannot return to the drugs that they had used for first-line treatment after already failing treatment with the same drugs. Also, there are only two options available in the first-line – Ipsen’s ‘Somatuline Autogel (lanreotide acetate)’ and Novartis’ ‘Sandostatin LAR (octreotide).’ Acromegaly is a rare disease in which the pituitary tumor causes hypersecretion of growth hormones to result in facial deformation and hypertrophy of the hands and feet. The key treatment objective for acromegaly is to reduce the level of growth hormones and insulin-like growth factor-1 (IGF-1) secretion. However, 45% of the patients who were treated with first-generation somatostatin analog (SSA) were unable to achieve biochemical control. Meanwhile, in a Phase III trial that compared Signifor LAR with a maximum dose first-generation SSA, Signifor LAR demonstrated superiority in ▲ Biochemical control (mean GH level under 2.5㎍/L and normal range IGF-1 level) ▲GH and IGF-1 control ▲decrease n tumor size Patients whose acromegaly was not adequately controlled after being treated for over 6 months existing SSA (octreotide 30mg or lanreotide 120mg) participated in the trial and were randomly assigned to Signifor LAR 40mg, 60mg, or first-generation SSA for treatment. Study results showed that the proportion of patients that met the primary endpoint of biochemical control at 24 weeks was 15% for the Signifor LAR 40mg group and 20% for the Signifor LAR 60mg group, which was higher than that of the control group (0%).
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- Hanmi’s poziotinib enters final phase for commercialization
- by Kim, Jin-Gu Dec 08, 2021 06:00am
- ‘Poziotinib,’ a drug licensed out by Hanmi Pharmaceuticals, is entering its last phase for authorization in the US. The variables that remain to approval are the US FDA’s interpretation of the clinical trial results and the on-site investigations on the company’s production and manufacturing facilities. If these progress as planned, Hanmi Pharmaceuticals will be able to achieve its first global commercialization landmark with the new drug technology export earlier next year. On the 6th (local time), the US company Spectrum Pharmaceuticals submitted a new drug application (NDA) for poziotinib. It is indicated for the treatment of locally advanced and metastatic HER2 Exon20 mutant-positive non-small cell lung cancer (NSCLC) in patients who have previous treatment experience. Poziotinib received the fast-track designation in March from the FDA. Drugs that receive the fast-track designation receive various support from the FDA in the stages of its development. Also, when applying for marketing authorization, the drugs are allowed to submit data sequentially under a rolling review as soon as data is available and are allowed to be discussed for priority review, etc. In particular, the priority review would shorten the FDA's marketing authorization review period from 10 months to 6 months. Considering the circumstances, Spectrum expects poziotinib to be approved in the US by the first half of next year. If poziotinib receives FDA approval, it would be a first for Hanmi to succeed in the global commercialization of a new drug that it had exported technology for. The variables that remain to approval now are poziotinib’s clinical trial data and on-site investigation. Spectrum submitted the NDA based on the cohort 2 results of the ‘ZENITH20’ clinical trial. Trial results showed that the objective response rate (ORR) of patients with HER2 Exon20 mutant-positive non-small cell lung cancer (NSCLC) with treatment experience was 27.8%, the median duration of response (mDOR) 5.1 months, and the median progression-free survival (PFS) 5.5 months. However, the drug showed somewhat less encouraging results in a clinical trial that was independently conducted in Europe. Professor Arsela Prelaj of the IRCCS National Cancer Institute Foundation in Italy compared data of 30 patients who were administered poziotinib to 28 that did not. No significant difference was found, with the overall survival (OS) of the poziotinib-treated group being 19.2 months compared to the 18.2 months in the control group. However, when matched by propensity score and calculated by Cox's proportional hazard regression model, the risk of death in patients who took ‘poziotinib’ was reduced by 34% at the most. Although no significant OS improvement was demonstrated in the study, the study still had meaning as it identified the possibility that the drug can reduce the risk of death. The results were announced at the ESMO virtual congress in September. The study was an investigator-led study without sponsorship from Hanmi or Spectrum. The other variable that remains is the on-site investigation. In the case of ‘Rolontis,’ another one of Hanmi’s technology export new drugs that Spectrum applied marketing authorization for, the on-site investigation had deferred what was on the brink of approval. The FDA determined that there were some problems with Hanmi’s factory in Pyeongtaek and sent a complete response letter (CRL) to Spectrum. Although Rolontis was expected to be approved in October last year, the FDA’s CRL has pushed back the schedule by over a year. Hanmi believes such an issue will not arise for poziotinib because the two drugs have different manufacturing facilities. An official from Hanmi said, “Rolontis is manufactured at Hanmi’s Pyeongtaek plant, whereas poziotinib is manufactured in the US. Also, most of the FDA’s requests for supplementation have been now addressed.” Therefore, the industry’s eyes are focused on whether Hanmi will be able to overcome its two previous failures and succeed in its third attempt. The FDA had deferred approval of Hanmi’s two technology export new drugs ‘Oraxol’ and ‘Rolontis’ in March and August this year. The company had licensed out the technology for its metastatic breast cancer drug Oraxol to Athenex but the FDA deferred its approval due to neutropenia concerns.
- Company
- Hanmi's lung cancer drug Poziotinib has been applied for NDA
- by Kim, Jin-Gu Dec 08, 2021 06:00am
- The U.S. FDA marketing approval process for Poziotinib, a new lung cancer drug developed by Hanmi Pharmaceutical, has begun. Hanmi Pharmaceutical's partner Spectrum announced on the 6th (local time) that it has submitted an NDA to the U.S. Food and Drug Administration (FDA). This indication is NSCLC with local progression and metastatic HER2 Exon 20 insertion mutation with treatment experience. This NDA submission is based on the positive cohort 2 results of the ZENITH20 clinical trial that evaluated the safety and efficacy of Poziotinib. Poziotinib was designated as FastTrack by the FDA. As a result of this indication, there are no FDA-approved treatments so far. Spectrum President Joe Turgon said, "HER2 Exon 20 insertion mutation has reached an important stage for achieving the first treatment for lung cancer patients. We thank researchers, patients, and spectrum executives and employees for their passionate efforts to achieve important milestones in areas with high unmet medical demand."
