- LOGIN
- MemberShip
- 2026-03-16 23:45:11
- Company
- MSD Korea to introduce cancer drug Welireg to Korea
- by Eo, Yun-Ho Aug 03, 2022 06:00am
- MSD is expected to introduce another oncology pipeline to Korea. According to industry sources, MSD Korea has submitted an application for the approval of its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, ‘Welireg (belzutifan),’ to the Ministry of Food and Drug Safety. The drug had been designated as an orphan drug in January for the treatment of Von Hippel-Lindau disease. The indication the company applied in Korea is also for the treatment of adult patients with VHL disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. After being first approved in the US in August, Welireg was also approved in the U.K. and Canada. As a HIF-2α inhibitor, Welireg reduces transcription and expression of HIF-2α target genes associated with cellular proliferation, angiogenesis, and tumor growth. Welireg’s efficacy was demonstrated through the open-label Study 004 trial which investigated 61 VHL-associated RCC patients diagnosed based on a VHL germline alteration and with at least one measurable solid tumor localized to the kidney. Patients enrolled in the trial had other VHL-associated tumors including CNS hemangioblastomas and pNET. The major efficacy endpoint of the clinical trial was the overall response rate (ORR) in patients with VHL-associated RCC as measured by radiology assessment using RECIST v1.1 as assessed by an independent review committee (IRC). Additional efficacy endpoints included duration of response (DoR) and time to response (TTR). In the trial, Welireg showed an ORR of 49% in patients with VHL-associated RCC. All responses were partial responses. The median DoR had not yet been reached, and the DoR among responders that were still responding after at least 12 months was 56%. Median TTR was 8 months. Also, in patients with VHL-associated CNS hemangioblastomas, Welireg showed an ORR of 63%, with a complete response rate of 4% and a partial response rate of 58%.
- Company
- Competitivity of K-Pharma-Bio manufacturing facilities rises
- by Lee, Seok-Jun Aug 03, 2022 06:00am
- The competitiveness of K-Pharma/Biomanufacturing facilities are rising. With more and more companies passing inspections by the US FDA (Food and Drug Administration), the institution considered to have the highest standards, the companies that have passed inspections plan to advance into the global market in earnest. Recieves first cGMP certification in Asia for its oligonucleotide manufacturing plant ST Pharm recently became the first in Asia to receive the US FDA’s Good Manufacturing Practice (cGMP) certification for its oligonucleotide plant. The company received an inspection classification of NAI (No Action Indicated) from FDA’s PAI (pre-approval inspection) of its oligonucleotide factory in Banwol Campus, demonstrating the R&D capability of its facility. With the approval, the company’s oligonucleotide orders are expected to increase. Although ST Pharm had only been exporting drug substances for oligonucleotide treatment used in clinical trials to the US market, the recent FDA cGMP approval will now enable the company to make large-scale exports for commercial use. An ST Pharm official said, “We have 4 more FDA PAIs planned by the first half of next year. This means that FDA approvals of new drugs that ST Pharm supplies drug substances for is imminent. The FDA cGMP approval the company received this time is expected to positively impact the future on-site inspections in plan.” Registered as the first anticancer drug API manufacturing facility in Korea Inist ST’s Osong plant has also recently been registered as a cGMP anticancer drug API manufacturing facility by the FDA. With the registration, the Osong plant became the first cGMP-certified anticancer API manufacturing facility registered as a highly active noncytotoxic anticancer API specialized manufacturing facility A company official said, “With the news spreading, we are receiving a series of love calls from existing and new customers that aim to advance into the US and other advanced pharmaceutical markets. The FDA certification has reaffirmed our global-level API manufacturing facility and quality control capabilities.” By passing FDA inspections, the pre-investment that had been made by Inist ST is also gaining momentum. In October last year, the company started the construction of a 40 billion won 'Global API synthesis cGMP plant' on the site of the Osong plant site to expand its CMO business. The facility is expected to be completed in October. Succeeds in manufacturing COVID-19 mRNA drug substance in addition to finished product Samsung Biologics succeeded in trial manufacture of the mRNA drug substance. With the company's success in establishing the mRNA drug substance facility following the successful CMO of Moderna’s finished mRNA product in the 2nd half of last year, the company has now established a one-stop end-to-end mRNA production system. The company signed aCMO partnership with the US company GreenLight Biosciences for the drug substance of GreenLight’s COVID-19 vaccine candidate at the end of last year. For 7 months since then, the company completed technology transfer, scale-up and established its RNA drug substance manufacturing facility in May this year. Samsung Biologics recently succeeded in the first trial manufacture and has finished preparations for the large-scale commercial manufacturing of the mRNA vaccine drug substance. Trial production is a process verification stage that is carried out before full-scale commercial production. The success of the pilot manufacturing is considered as having full capacity at the cGMP level. The second trial production is expected to take place within this month. A market official said, “An increasing number of pharmaceutical and biopharmaceutical companies have passed FDA’s inspections with their differentiated manufacturing facilities. Such facility R&D is now treated as competitive as the company's material R&D.”
- Company
- Lilly appoints new CEO Christopher J. Stokes
- by jung, sae-im Aug 03, 2022 06:00am
- Christopher J. Stokes, new CEO of Lilly KoreaLilly Korea announced on the 1st that it has appointed Christopher J. Stokes as its new CEO. The new CEO is a pharmaceutical and healthcare expert who has extensive work experience in the global pharmaceutical industry for more than 15 years. He graduated from George Mason University in 2002 and earned a master's degree in public administration from Indiana University Bloomington in 2005. Stokes, who first joined Eli Lilly's U.S. headquarters as a public policy analyst in 2008, has demonstrated excellent performance and positive influence through various roles, from foreign cooperation to rental and drug prices, strategic planning, new product planning, brand policy marketing, and sales management. In particular, he established leadership by serving as Chief Operating Officer (COO) of the Neuroscience Director of Sales for the West Area and Eli Lilly headquarters. From 2020 until recently, he represented Eli Lilly's South Africa and Sub-Saharan Africa offices. CEO Stokes said, "As I am newly appointed as the representative of Lilly in Korea, I will do our best to help more Korean patients lead a better life through Lilly's innovative medicine and further deliver a positive influence on Korean society." Alberto Riva, who previously served as the representative of Lilly Korea, was newly appointed as the representative of the Brazilian branch of Eli Lilly. Since taking office in Lilly Korea in September 2019, President Riva has contributed to the growth of Lilly Korea by supplying treatments in various fields of diseases such as anticancer drugs, diabetes, and autoimmune diseases in Korea.
- Company
- Mundipharma is pushing for its first employee reduction
- by jung, sae-im Aug 03, 2022 06:00am
- The impact of Mundipharma's reduction of narcotic analgesics business is also affecting Korean corporations. A major reorganization is taking place, cutting two-thirds of the department's workforce. According to the pharmaceutical industry on the 3rd, Mundipharma is conducting ERP with the aim of finishing at the end of August. The target is the department in charge of narcotic painkillers among the two Rx departments. This is the first time Mundipharma has conducted an ERP. The voluntary retirement is attributed to global Mundipharma's massive reduction of its narcotic painkillers business. This is because opioid-based narcotic painkillers have emerged as a social problem in the U.S. due to death and addiction caused by overdose, and related pharmaceutical companies have been fined trillions of won. It is considered a "panic drug" and the number of deaths from drug abuse has increased rapidly. According to the CDC, opioid addiction killed about 500,000 people over the past 20 years from 1999. Purdue Pharma, the parent company of Mundipharma, admitted responsibility for overdosing opioids, filed for bankruptcy, and decided to pay 5 trillion won in settlements to 15 states, including New York. At the same time, he also expressed his willingness to sell Mundipharma. Until recently, follow-up measures have continued, such as pushing for the sale of Mundipharma's Chinese subsidiary. Mundipharma has stopped all research and development on narcotic painkillers and has launched a major reduction aimed at abolishing the division. The compensation condition is '2n+8 (two times the number of years of service plus eight months' salary), which is known as the industry's average level. On top of that, the company plans to pay additional special consolation money for annual leave. The problem is that there is a high possibility that ERP applicants will fall short of this due to the large number of job cuts planned by the global community. It is known that less than half of the applicants were applied a day before the actual application deadline. The company's plan to finish ERP within August is also tight. If the gap is large, conflicts between the management trying to fill the number of people somehow and workers to prevent it could arise. Mundipharma reportedly expressed its willingness to complete the ERP smoothly by consulting with the labor union as much as possible. A union official also said, "As global companies are pushing to reduce their business units, Korean corporations are also affected." Mundipharma said, "We will communicate closely with the company regarding ERP and try to solve the problem smoothly."
- Company
- LG Chem Applies to FDA for Phase 3 of Gout New Drug
- by jung, sae-im Aug 03, 2022 06:00am
- LG Chem announced on the 1st that it has applied for a phase 3 clinical trial plan for Tigulixostat, a new gout drug developed by the U.S. Food and Drug Administration (FDA). This is the first time that LG Chem has started phase 3 clinical trials of new drugs in global regions such as the U.S. The company's strategy is to significantly expand its bio business area centered on domestic demand and emerging markets to the U.S. and Europe. This clinical trial evaluates safety and effectiveness compared to placebo in 350 adult gout patients with hyperuricemia in multiple countries, including the United States, at the point of six months of taking Tigulixostat. The primary evaluation index was set as the proportion of patients who reached serum uric acid concentration of 6 mg/dL for 6 months. LG Chem will also apply to the FDA for a comparative test plan with Allopurinol, the primary treatment ingredient for gout patients with hyperuricemia. Its strategy is to prove differentiated efficacy and long-term use safety through recruiting large-scale global test groups. LG Chem aims to sell globally from 2028 after obtaining approval for item approval as a first treatment from the U.S. FDA in 2027. Tigulixostat inhibits the expression of the enzyme xanthine oxidease that produces uric acid, which is the main cause of gout. As a result of the U.S. Phase II results, Tigulixostat showed a rapid and strong uric acid drop effect, the company explained. According to the global market research firm CMI (Coherent Market Insights), the global gout treatment market is expected to expand from 3 trillion won in 2019 to 5 trillion won in 2027 due to aging population and increasing obese population. Currently, there are 35 million patients diagnosed with gout worldwide, of which the number of patients in the U.S. and China is estimated to be 10 million and 14 million, respectively. "Tigulixostat global phase 3 will be a solution to further strengthen LG Chem's new drug clinical, licensing, production, and sales capabilities," said Sohn Ji-woong, head of the Life Science Business Division. "We will lay a new turning point in the gout treatment market through clinical strategies and preemptive commercialization preparation."
- Company
- SK Bioscience has applied for CMA of SKY Covione
- by Kim, Jin-Gu Aug 02, 2022 06:02am
- SK Bioscience announced on the 29th that it has applied for Conditional Marketing Authorization (CMA) of the COVID-19 vaccine to MHRA, a British pharmaceutical regulator. The product name in the UK and Europe is SKY Covione. SK Bioscience explained that it has been conducting a Rolling Review since March to receive prompt approval from MHRA. Rolling Review is a system that quickly evaluates promising vaccines and treatments by submitting efficacy, safety, and quality data sequentially before applying for final permission. SK Bioscience submitted additional phase 3 clinical data recently secured to MHRA. MHRA will begin a full-fledged review for SKY Covione's CMA. Starting with the UK, SK Bioscience plans to apply for CMA to the European Medicines Agency (EMA) in the future and apply for registration on the World Health Organization's Emergency Use List (EUL). Ahn Jae-yong, president of SK Bioscience, said, "This application for permission will take the first step to introduce a domestic COVID-19 vaccine with excellent safety and immunity to the global big Pharma-centered COVID-19 vaccine market." Starting with the application for CMA in the UK, we will introduce Korea's technology to the global vaccine market through Europe and WHO EUL listing, he said. "In addition, it will contribute to restoring safe daily life through COVAX Facility." In June, SK Bioscience was approved for "SKY Covione multi injection" as the first domestic COVID-19 vaccine. SKY Covione is a COVID-19 vaccine developed by SK Bioscience based on its global network. It was jointly developed by IPD and SK Bioscience at the University of Washington, USA, and GSK's Adjuvant AS03 was applied to strengthen the immune response. It received development cost support from BMGF and CEPI from the early stage of development, and plans to be supplied to the global market through COVAX Facility after acquiring WHO EUL. SKY Covione demonstrated excellent immunogenicity and safety during basic vaccination through phase 3 clinical trials of 4,037 adults in five countries at home and abroad. Additional studies in phase 1/2 of the SKY Covione clinical trial showed a high immune response to the omicron mutation (BA.1). SK Bioscience is conducting clinical trials for ▲ heterogeneous booster shots and ▲ of the same kind of booster shot , and it plans to conduct ▲ an additional study to confirm the response effect of omicron mutations.
- Company
- Dong-A ST, applies for permission to Sugadapa
- by Kim, Jin-Gu Aug 02, 2022 06:01am
- Dong-A ST announced on the 29th that it has applied to the MFDS for the item license of type 2 diabetes complex Sugadapa. Sugadapa is a complex that combines Evogliptin 5mg, the main ingredient of the DPP-4 inhibitor-based diabetes drug Suganon, developed by Dong-A ST, and Dapagliflozin 10mg, the SGLT-2 inhibitor-based drug. DPP-4 inhibitors can control blood sugar without weight gain and hypoglycemic side effects. SGLT-2 inhibitors are known to reduce blood sugar while causing little hypoglycemia, reduce weight and blood pressure, and relieve heart failure. An official from Dong-A ST said, Sugadapa is expected to improve blood sugar control in diabetics and improve convenience and medication compliance, so we will lead the diabetes market with Sugadapa, which combines the advantages of Evogliptin and Dapagliflozin. Dong-A ST's Suganon was approved by the MFDS in 2015 as the 26th new drug in Korea. In 2016, it was approved for the approval of Sugamet, a combination of Suganon and Metformin. If Sugadapa is licensed, it will be the third drug in the Suganon series.
- Company
- SK Bioscience applies for CMA of its COVID-19 vaccine to EMA
- by Chon, Seung-Hyun Aug 02, 2022 06:01am
- On the 1st, SK Bioscience announced that it has submitted an application for a Conditional Marketing Authorization (CMA) of its COVID-19 vaccine, ‘SKYCovion,' to the European Medicines Agency (EMA), SKYCovion is a COVID-19 vaccine that induces neutralizing antibody responses by administering an antibody protein made with SK Bioscience’s recombinant protein vaccine technology. SKYCovion was developed with SK Bioscience’s recombinant protein vaccine technology and the ‘self-assembly nanoparticle’ design technology of the Institute for Protein Design (IPD) at the University of Washington School of Medicine. From the initial stages of development, SKYCovion has been supported by funding from the Bill & Melinda Gates Foundation and Coalition for Epidemic Preparedness Innovations (CEPI). SKYCovion will be available through the COVAX Facility, etc. for procurement and equitable allocation worldwide after it is approved for Emergency Use Listing (EUL) by the World Health Organization (WHO). The company had previously applied for a Conditional Marketing Authorization (CMA) of SKYCovion to the UK Medicines and Healthcare Products Regulatory Authority (MHRA). Starting with the U.K. and European countries, the company plans to introduce this competitive domestic vaccine to the rapidly growing global COVID-19 vaccine market. According to Airfinity, a global healthcare market analysis institution, the global COVID-19 vaccine market size is estimated at around $65.6 billion (₩78 billion) last year, which is twofold the market size of all other vaccines (estimated at $33 billion). With the European Centre for Disease Prevention and Control (ECDC) and EMA that oversees the disease control and healthcare policy in the European Union lowering the vaccination age for the fourth dose from 80 to 60, the European market size for COVID-19 vaccines is expected to further increase. Jaeyong Ahn, CEO of SK bioscience, said, “The daily lives of people around the world are being threatened with the repeated emergence of new COVID-19 variants. We aspire to fulfill our role and responsibility as a global vaccine hub by entering overseas markets with our self-developed vaccine and developing new platforms to respond to the endemic."
- Company
- Daewoong Pharmaceutical's biggest quarterly performance ever
- by Kim, Jin-Gu Aug 01, 2022 09:16pm
- Daewoong Pharmaceutical achieved its highest quarterly performance ever. Separately, sales in the second quarter increased 7.6% year-on-year to 293.8 billion won and operating profit increased 25.8% to 33.6 billion won. Both sales and operating profit are all-time highs based on quarterly performance. Earlier, Daewoong Pharmaceutical also set the highest quarterly operating profit in the first quarter. It then broke its quarterly operating profit record once again for the first time in a quarter. Nabota enters the European market in the second half of the year Daewoong Pharmaceutical cited Nabota's propaganda as one of the reasons for achieving its biggest performance. According to the company, Nabota's second-quarter sales amounted to 37.1 billion won, up 60% from 23.2 billion won a year earlier. Nabota's exports grew 105% from 14.2 billion won to 29.2 billion won during the same period. U.S. exports account for the largest share of Navota exports. Exports to U.S. sales partner Evans doubled from the previous year to 21.1 billion won. Daewoong Pharmaceutical explained that exports to Southeast Asia and Central and South America were also strong. The recent rise in the exchange rate also contributed positively to the improvement of export performance. Sales in the specialized medicine sector rose 5.5% to 205.8 billion won from 5.1 billion won in the second quarter of last year. High-yield products such as hyperlipidemia treatment Crezet, diabetes treatment "Diabex" and antithrombotic Anplone increased by 10% compared to the same period last year. Sales of Forxiga, a diabetes treatment drug in charge of domestic distribution by Daewoong Pharmaceutical, also grew by more than 30% in a year, contributing to sales expansion. The OTC sector posted 34.3 billion won in sales, up 19.9% from 28.6 billion won in the second quarter of last year. Due to the spread of COVID-19, the fever reducer EZN6 grew 45% year-on-year. Ursa, a liver improvement functional drug, also grew by more than 30% during the same period. In the case of health functional foods, sales doubled in a year. Daewoong Pharmaceutical said it is expected to continue to increase profitability in the second half of this year. Nabota, which has become Daewoong Pharmaceutical's new cash cow, is set to be released in Europe, Turkey, and Chile after the third quarter. The addition of FexuClue, a new drug for gastroesophageal reflux disease released by Daewoong Pharmaceutical earlier this month, is also expected to increase its performance. Daewoong Pharmaceutical is moving quickly to expand FexuClue's market share. In Korea, the special features of FexuClue are actively informed to medical staff across the country through various channels. In the case of overseas markets, it has signed 1.1 trillion won worth of technology exports with 15 countries around the world, and plans to expand its export range sequentially to foster it as a global blockbuster new drug. An official from Daewoong Pharmaceutical said, "Nabota's expansion of its market share in major global botulinum toxin markets, including the United States, led to the highest quarterly sales and operating profit ever." He said, "We expect the company's growth and return to rise together when sales of FexuClue, a new drug for gastroesophageal reflux disease, are visible in the third quarter and Nabota is released in Europe and elsewhere."
- Company
- Yuhan Corporation records new quarterly sales
- by Chon, Seung-Hyun Aug 01, 2022 09:14pm
- Yuhan set a new quarterly sales record. In the domestic market, both Rx and OTC drugs were strong, and overseas businesses were also doing well. Operating profit fell due to a decrease in technology fee revenue and an increase in R&D investment. Yuhan Corporation announced on the 28th that its operating profit based on separate financial statements in the second quarter fell 61.9% year-on-year to 10.8 billion won. Sales increased 10.4% year-on-year to 468 billion won. The company's second-quarter sales are the largest ever. It broke 439.4 billion won in the fourth quarter of 2020 for the first time in six quarters. Both domestic demand and overseas business showed growth. In the domestic market, sales of the OTC business were 49.1 billion won, up 23.9% from 39.7 billion won a year earlier. In the second quarter of last year, sales of Rx increased 8.9% year-on-year to 283.6 billion won. Sales of cold medicine Cough rose 154.2% to 7.3 billion won from 2.9 billion won in the second quarter of last year. Due to the spread of COVID-19, it has benefited from the increase in demand for cold medicines. Among the new drug products introduced by multinational pharmaceutical companies, sales of the diabetes treatment Jardiance rose 44.5% year-on-year to 20.5 billion won, and the hypertension treatment Twynsta rose 20.3% to 23.8 billion won. Vemlidy, a hepatitis B treatment, sold 11.6 billion won worth, up 38.4% from the previous year. Yuhan's overseas business sales amounted to 56.8 billion won in the second quarter, up 55.1% from 36.6 billion won in the same period last year. Yuhan buys raw materials produced by Yuhan Chemical and exports them to multinational pharmaceutical companies. Yuhan Corporation's technology fee revenue, which has emerged as a cash cow, has decreased. The company's second-quarter technology fee revenue was 5.2 billion won, down 69.0% from 16.7 billion won a year earlier. Starting with Spinebiopharma in 2018, Yuhan Corporation signed contracts to export new drug technologies with five global pharmaceutical companies, including Janssen Biotech, Gilead Bioscience, Beringer Ingelheim, and Processa Pharmaceutical. Except for Processa Pharmaceuticals, which paid the down payment in stocks, the down payment and milestones received from the remaining four companies are recognized in installments. Technology fee revenue is bound to show ups and downs due to the characteristics of new drug technology export contracts or technology transfer new drug development stages. Leclaza, which transferred technology to Janssen, made a total of $100 million in additional technology fee revenue before the development stage, but no large-scale technology fee revenue occurred this year.
