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- 2025-12-24 21:46:20
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- Nabota's sales in US in 1Q of the year were 92 billion won
- by Aug 08, 2022 06:09am
- Daewoong Pharmaceutical's botulinum toxin drug Nabota broke a new quarterly sales record in North America. Sales also improved in the second quarter following the first quarter, surpassing 90 billion won in sales in the first half. Daewoong Pharmaceutical's partner Evolus announced on the 3rd (local time) that its sales of Jubo (Nabota) reached $37.16 million in the second quarter. This is an increase of 46.3% compared to the same period last year. This quarter's sales are the highest since Navota's launch in North America in the second quarter of 2019. It surpassed 34.66 million dollars in the fourth quarter of last year, breaking a new quarterly sales record. Nabota's sales in North America in the first half of the year increased 87% year-on-year to $70.39 million. Since its launch, its cumulative sales have reached $260.2 million. Evolus is a global copyrighted partner of botulinum toxin Nabota developed by Daewoong Pharmaceutical. Since approval by the U.S. Food and Drug Administration (FDA) in February 2019, Nabota has been actively sold in North America. In particular, it resolved the negative factors by ending the International Trade Commission (ITC) dispute with Allergan and Medy Tox early last year. It has become possible to actively market Jubo without legal concerns. Navota's quarterly sales, which stood at $20 million last year, exceeded $30 million for the first time in the fourth quarter of last year. Nabota added 590 new accounts in the second quarter, securing more than 8,100 customers so far. The percentage of re-orders remains above 70%. In the first half of this year, about 180,000 Evolus Reward loyalty programs were used. Evolus is conducting more aggressive marketing. Following the creation of more than 250 million media exposures in the second quarter, it also launched the largest promotional campaign under the name of "Switch Your Tox and Love Evolus Forever" last month.
- Company
- 3rd PD-1i Jemperli to soon receive approval in Korea
- by Eo, Yun-Ho Aug 05, 2022 06:06am
- A third PD-1 inhibitor is knocking to enter the Korean market. According to industry sources, GSK Korea’s PD-1 inhibitor cancer immunotherapy ‘Jemperli (dostarlimab),’ which the company applied for approval earlier this year, may be approved within the year. If approved, Jemperli will become the third PD-1 inhibitor introduced to the Korean market following Ono·BMS’s ‘Opdivo (nivolumab),’ and MSD’s ‘Keytruda (pembrolizumab).’ Unlike the other two drugs that were first indicated as melanoma treatments, Jemperli was first approved in the US in April last year as a treatment for mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.’ In August of the same year, Jemperli was additionally approved for the treatment of adults with dMMR recurrent or advanced solid tumors who have progressed on or following previous treatment and have no satisfactory therapeutic options. GSK plans to add other indications to endometrial cancer in Korea as well. The efficacy of Jemperli was confirmed through the multicohort GARNET trial that included a cohort of patients with dMMR/MSI-H endometrial cancer who progressed on or following prior treatment with a platinum-containing regimen. Trial results showed an objective response rate (ORR) of 43.5% and the disease control rate of 55.6% in the Jemperli-treated group. The median duration of response was not reached yet, and the rate of patients whose duration lasted 6 months and 12 months were 97.9% and 90.9%, respectively. Meanwhile, the other companies are also actively working to expand their indication and reimbursement for Keytruda and Opdivo in Korea as well. MSD succeeded in expanding the reimbursement standards for Keytruda to first-line NSCLC in 1H this year, and Opdivo's indication as a first-line treatment in gastric cancer has passed the Health Insurance Review and Assessment Service’s Cancer Disease Deliberation Committee.
- Company
- Celltrion, applies for Phase III U.S. Targeting
- by Lee, Seok-Jun Aug 05, 2022 03:32am
- A clinical trial will be conducted so that Celltrion can alternatively prescribe CT-P17 (Yuflyma), an autoimmune disease treatment developed by itself, with the original Humira. Celltrion announced on the 1st that it recently submitted a global phase 3 to the FDA to secure interchangeability between CT-P17 and Humira. If it is designated as an interchangeable biosimilar, it can be prescribed by replacing the original at a pharmacy without intervention by a doctor. Phase 3 is conducted in 366 patients with plaque psoriasis. Pharmacokinetics, efficacy, and safety will be compared and verified between the group that took multiple intersections between Yuflyma and Humira and the group that administered Humira. Yuflyma is the world's first high-concentration Humira biosimilar that obtained permission from the European Medicines Agency (EMA). It was developed as a formulation that halves drug administration compared to low concentrations and removes citrate, which can cause pain. It started selling in major European countries, and the U.S. has completed a patent agreement with U.S. developer Abbvie so that it can start selling on July 1st next year, and expects FDA approval by the end of this year. Celltrion plans to secure Humira's interchangeable biosimilar status in the U.S. through interchangeable clinical trials with the advantages of Yuflyma's high-concentration formulation. Humira's global sales last year were about $20.69 billion and $17.33 billion in the United States.
- Company
- Oncaspar changed supplier
- by Eo, Yun-Ho Aug 05, 2022 03:28am
- Oncaspar, a combination treatment for acute lymphocytic leukemia (ALL), which has been supplied by developer Servier, is forming a stable prescription maintenance environment. According to related industries, it passed the Drug Committee (DC) of the Big 5 general hospitals, including Samsung Medical Center, Seoul National University Hospital, and Sinchon Severance Hospital. Since May, the supplier has been changed at the rare drug center, but the prescription code has been quickly secured. Oncaspar obtained permission for import items from the MFDS in February last year as a combination therapy with other anti-tumor drugs when treating Acute Lymphoblastic Leukemia (ALL). This drug maximizes the drug circulation half-life through pegylation, dramatically reducing the frequency of administration to be administered once every 14 days compared to L-asparaginase, which was previously administered once every other day. Considering the high incidence of Acute Lymphoblastic Leukemia, in particular in pediatric patients, improved use to allow administration every 14 days is expected to reduce injection burden, physical pain, and hypersensitivity to injection treatments in pediatric patients and patient caregivers suffering from frequent anti-cancer injections. In addition, it is expected to have a positive effect on medical costs such as hospital visits or hospitalization for injection treatment. First approved in 1994 as a secondary treatment for Acute Lymphoblastic Leukemia in the United States and Germany, Oncaspar was recognized as a primary treatment for all Acute Lymphoblastic Leukemia in the United States in 2006. Since birth in Europe in 2016, it has been approved as a combination therapy with other anticancer drugs in children and adults with acute lymphocytic leukemia aged 18. Oncaspar is currently a treatment for Acute Lymphoblastic Leukemia, which is primarily recommended in major international guidelines and treatment protocols such as NCCN, ESMO, and Children's Oncology Group (COG), and is used in 62 countries.
- Company
- Samjin, will develop new drugs with AI company in Canada
- by Lee, Seok-Jun Aug 05, 2022 03:28am
- Samjin Pharmaceutical announced on the 2nd that it has signed a joint research contract for AI new drug development with Cyclica, a Canadian artificial intelligence new drug development platform company. Through the agreement, Samjin Pharmaceutical will propose to Cyclica multiple drug targets currently under review. Cyclica is going to secure candidate materials that are highly likely to be developed by applying AI-based new drug candidate material discovery platform (Ligand DesignTM) technology. Lee Soo-min, head of the Samjin Pharmaceutical Research Center, said, "Joint research using AI technology with Cyclica will significantly reduce the time and cost required to develop new drugs. We will cooperate with leading domestic and foreign research institutes and companies to efficiently discover and develop innovative new drugs through open innovation strategies." Cyclica was selected as one of the world's 13 healthcare AI startups by CB Insights, a technology market research institute in 2020. It is conducting joint research with many domestic and foreign companies including global Big Pharma such as Merck KGaA and AstraZeneca.
- Company
- Chinese partner terminates agreement with Medytox
- by Nho, Byung Chul Aug 04, 2022 06:04am
- Medytox is having difficulty making entry into the Chinese market. At a presentation on ‘Follow-up regarding Bloomage·Medytox joint venture Medybloom's progress' that was held on the 1st, Bloomage Biotechnology announced that “the company will discontinue the partnership with Medytox and seek opportunities with other botulinum toxin companies." As one of the largest hyaluronic acid production and marketing enterprises in the world, Bloomage Biotechnology is known for its professional sales power in China's cosmetic surgery market. With the termination of the partnership, Medytox will now have to seek new venues for entry into the Chinese market without achieving much during the 5 years after establishing the joint venture, MedyBloom China, with Bloomage Biotechnology in 2017. Medytox applied for the approval for its botox product Meditoxin (Neuronox) to the National Medical Products Administration in China in February 2018, but the agenda is pending for over 4 years. Moreover, the global pharmaceutical company Allergan (currently Abbvie) returned the rights of Medytox’s liquid botulinum toxin candidate (MT-10109L) to Medytox in September last year. This return of rights, which occurred 8 years after the company licensed out the development and global sales rights of its liquid botulinum toxin candidate to Allergan in September 2013, was expected to have caused considerable aftermaths for the company. With the termination of the agreement, Medytox will not be able to receive the remaining milestone payments ($262 million/ ₩342.5 billion) from Allergan. Allergan had planned to sell the liquid botulinum toxin in the global market excluding Korea and Japan after undergoing clinical trials and approval processes, but this is also now unclear. With Medytox facing difficulties in 2 of the 3 largest global botulinum toxin markets - the US and China - other competitors are accelerating their market defense and penetration strategies for their botox products. Hugel’s Letybo continues to rank first in the Korean market and is solidifying its position as the market leader with the recent marketing authorization and launch of its botulinum toxin in China. Daewoong’s Nabota has also been increasing its global market sales and shares upon receiving marketing authorization and release in the US. Also, Nabota is coordinating the timing for its entry into the European market, and is on the verge of achieving a grand slam of being approved in all three global major markets as it has completed Phase III clinical trials and is about to receive marketing authorization in China. Meanwhile, Medytox had relayed to the press that “We received a letter from Bloomage regarding the contract termination, but nothing has been finalized. We will be reviewing measures from various angles to come up with the optimal plan for entering the Chinese botulinum toxin market.”
- 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."
