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- The 38th JP Morgan Healthcare Conference ended
- by Kim, Jin-Gu Jan 21, 2020 06:24am
- Se-chang Kwon, president of Hanmi Pharmaceutical, who attended the 38th JP Morgan Healthcare Conference, announces the vision of Hanmi Pharmaceutical and its 2020 R&D strategy The 38th JP Morgan Healthcare Conference ended. This year, more than 30 Korean pharmaceutical bio companies visited San Francisco, USA. Seven companies, including Samsung BioLogics, Celltrion, Hanmi Pharm, and LG Chem, made public announcements. Other pharmaceutical companies also had a competition behind the curtains There are three keywords that summarize the performance of Korean companies who attended this year's JP Morgan Healthcare Conference: ▲overseas expansion, ▲metabolic disease, and ▲global clinical launch. Samsung Biologics and Celltrion, two of the largest 'guests' of Korean companies, announced their plans to directly target overseas markets. Hanmi Pharm, LG Chem, and Daewoong Pharm introduced plans to develop metabolic diseases such as diabetes and obesity. The world's first non-alcoholic steatohepatitis (NASH) drug under development by Hanmi and Daewoong's next-generation gastroesophageal reflux disease drug have once again announced that global clinical trials are going well. SK Biopharm's Excopry and Sunosi announced their launch and full-scale sales in the US and Europe respectively. The presentations and activities of each company's JP Morgan Healthcare Conference are as follows. ◆Samsung Biologics = Samsung Biologics announced in April that it will establish a R&D Center for Biopharmaceutical Development (CDO) in San Francisco. Samsung Bio is the first US subsidiary. The strategy is to establish a forward base in the US, the largest market. First, the company aims to increase contract development orders, and eventually expand the scope to consignment production (CMO). Samsung Biologics' number of CMO items increased to 27 in 2018 and 35 in 2019. This year, the plan is to increase the number to 47. For this, it said that it is considering the construction of a fourth plant in Songdo, Incheon. At present, the 3 plants of 364,000 liters are said to be in full operation. What Samsung Biologics expects is Biogen's Alzheimer's drug. At the conference, Biogen said it is pushing for a US product license to launch the Alzheimer's drug, Aducanumab. Samsung Biologics and Biogen are deeply connected as the first and second shareholders of Samsung Bioepis. ◆Celltrion = Celltrion announced that it will launch into China after Europe and the US. Celltrion plans to enter the Chinese market by itself, not in the form of a joint venture (JV). This goal was announced directly by Chairman Jung-jin Suh. "We are working on a business agreement with the provincial government of China to build 4 plants of 120,000 liters locally, and we are going to make an agreement this month, and we will start construction in April". He also introduced plans for the development of an insulin biosimilar. Through self-development and co-development, he has succeeded in the diabetes treatment market of ₩47 trillion worldwide. Chairman Jung-jin Suh also announced the possibility of the merger of Celltrion Group. In the Q&A process, he mentioned the possibility of merging Celltrion, Celltrion Healthcare, and Celltrion Pharmaceuticals. The merger's market cap is estimated at ₩23 trillion. However, Celltrion is conducting an internal review of the merger on the premise that the share of shareholders of the company and its affiliates is high on the following day, but there are no specific details such as the method and timing of the merger. ◆Hanmi Pharm = Hanmi Pharm has focused on the introduction of NASH drugs and obesity drugs returned from Janssen. HM15211, which is being developed as a NASH treatment, said it plans to launch a global clinical phase II in the second quarter of this year. According to the phase I of clinical trials, various effects, including rapid and strong fatty liver reduction, were confirmed. Another key challenge, the HM12525A, was also introduced. Last year, Janssen returned the rights to Hanmi after completing Phase II clinical trials. Janssen has been conducting Phase II clinical trials to develop drugs that treat obesity and diabetes. Unlike Jansen, Hanmi Pharm plans to develop this drug as a dual-mechanism for obesity, which is superior to existing drugs. Hanmi Pharm explained that it is the world's first once-weekly anti-obesity drug, and demonstrated the superior weight loss effect compared to the existing daily anti-obesity drug through Global Phase II. ◆Daewoong Pharmaceutical has unveiled its global development roadmap for 'Fexuprazan', the next-generation gastroesophageal reflux disease treatment. Last year, Phase III clinical trials were completed, and a product license was applied to the MFDS. In particular, it plans to enter clinical trials in the US and China within this year. Through this, it announced that it would enter the global market worth ₩40 trillion. In addition, Daewoong introduced the positive results in Phase III clinical trials of HL036, a new dry eye treatment drug under development with Hanall Biopharma. ◆LG Chem = Ji-woong Sohn, head of the Life Sciences Division, explained the anticancer, immune, diabetes, and metabolic disease pipelines. According to LG Chem, the drug, gout treatment entered the US Phase II trial, inhibits xanthine oxidase which is a protein involved in the excessive production of uric acid. In the previous phase I, the possibility of side effects of cardiovascular disease indicated as a disadvantage of the existing uric acid inhibitors was low. ◆SK Biopharm has updated its sales plans for the new epilepsy drug, Excopry, and the sleep disorder, Sunosi. In case of Excopry, it plans to start negotiations on drug prices and full-scale marketing activities for Excopry from March after the US DEA review. Sunosi expects to be approved for a European marketing license as early as next week. Jazz Pharmaceuticals, which bought Sunosi's technology, said Sunosi's European Drug Administration's product licensing is expected next week. Through this, in June, it announced plans to launch in Germany throughout Europe. ◆Genexine = HPV vaccine GX-188E has been released. GX-188E is undergoing phase 2a clinical trial with Kitruda in patients with recurrent or metastatic cervical cancer. Genexine explained that it achieved the planned target response rate early. ◆SCM Life Sciences reportedly focused on finding clinical partners in the field of kidney cancer. The company announced last week that it has applied for a phase 2b trial with the US FDA. ◆Genome&Company = Genome & Company, a microbiome company, said it has signed a combined clinical contract with Merck and Pfizer, a global pharmaceutical company. Phase I clinical trial for the combination of Merck and Pfizer's anticancer drugs, Bavencio and Genome&Company, for GEN-001. ◆HLB said it had concurrent meetings with multinational pharmaceutical companies for licensing in and out agreements. The company said it had a meeting with a Japanese and European partner to license out Rivoceranib, which is being developed for gastric cancer treatment. However, the sales schedule for Rivoceranib scheduled for the fourth quarter was explained as "The FDA continues to discuss." ◆Eubiologics announced that it has signed a Term Sheet agreement with POP Biotech in the US to establish a joint venture. It is a combination of Eubiologics' EuIMT(immune enhancer) technology and POP Biotech's SNAP platform (antigen delivery) technology. The company announced that it reported establishment in the US within March of this year and develop vaccines against respiratory syncytial virus (RSV), shingles virus (VZV) and Alzheimer's as its primary targets.
- Company
- The Rx rate of Lipitor and Plavix is high
- by Chon, Seung-Hyun Jan 20, 2020 06:27am
- Last year, the strength of patent expiration drugs stood out in the top domestic outpatient drug market. Lipitor, a hyperlipidemia treatment drug, continued to rise and remained No.1 in the prescription market for two consecutive years. The antithrombotic drug Plavix has grown by about 50% in five years. 'Twynsta', 'Crestor', and 'Aricept' also increased the amount of prescriptions despite the generics. Among the products developed by domestic companies, 'Gliatamin' and 'Rosuzet' showed a remarkable progress. Last year, Lipitor took the lead in outpatient Rxs of ₩176.2 billion, according to drug research agency UBIST. It was 8.4% higher than the previous year, winning the Rx market for two consecutive years. In 2017, Gilead's hepatitis B treatment, Viread, ranked first. Outpatient Rx Performance Rank by item in 2019 (Unit: ₩100 million,%, Source: UBIST) Lipitor is clearly ranked first in the outpatient Rx market with a gap of ₩69.4 billion from the second-largest Viread. Hyperlipidemia drug Lipitor by Pfizer Lipitor, which was released in Korea in 1999, is exceptional. More than 100 generic products have entered since 2009, and insurance prices have fallen by half compared to before patent expiration. Pfizer recently received a series of large-scale clinical studies on Koreans, engaged in a variety of social contribution activities, and is said to have concentrated on Lipitor. Last year, the prescription market showed the most notable increase in patent expired drugs. .Sanofi's Plavix last year recorded prescription results of ₩88.9 billion, up 17.3% from the previous year .Rx amount of Plavix increased 28.1% in two years from ₩69.4 billion in 2017 .Prescription performance of Plavix has risen by 48.2% in five years from ₩60 billion in 2014 .The patent expired in 2007 and has entered more than 120 generics .The accompanying rise in patent expired drugs is a very unusual phenomenon .In general, the market share drops rapidly after the release of drugs such as generics or salt-changed generics .In the domestic market, the market share is increasing .Prescriptions also increased last year, compared to last year's generic competition, including Boehringer Ingelheim's Twynsta, Eisai's Aricept and Novartis' Exforge .Due to the domestic drug price system, original drugs are said to be favorable for market share expansion .In Korea, when generics are released, the drug price of original drugs drops to the previous 70% level .After one year, the price will drop to 53.55% before patent expiration .The upper limit of the generic drug can be up to 59% of the original drug before the patent expires, and after one year, the price goes down to 53.55% like the original .After the patent expiration of new drugs, drug prices were similar to those of generics, and it is analyzed that the prescription of the original drug has increased in the prescription field .It is estimated that the market defense of patent expired drugs is firmly established by strengthening sales activities of domestic pharmaceutical companies .Lipitor is sold jointly by Jeil Pharm, while Plavix and Twynsta are sold by Dong-wha and Yuhan .Domestic patented new drug products such as Crestor (Daewoong), Aricept(Chong Kun Dang), and Harnal(Boryeong) also joined the business .Viread, which ranked No .1 in prescription drugs in 2017, fell outpatient prescriptions at ₩106.4 billion last year, down 30.5% YoY .The gap with leading Lipitors widened sharply due to drug price cuts and a decline in market share .Daewoong Bio's “Gliatamin,” a brain function improving agent of “Choline Alfoscerate”, recorded the most of ₩91.6 billion of outpatient prescriptions last year .It is up 19.5% from ₩76.7 billion in 2018 .Chong Kun Dang's “CKD Gliatilin Soft Cap” of the same ingredient also posted a prescription of ₩72.3 billion, up 14.9% from the previous year .Last year, the effectiveness of choline alfoscerate was debated, but it still rose sharply .'Rosuzet', launched by Hanmi in late 2015, recorded ₩77.3 billion, up 36.4% from last year .Rosuzet is a hyperlipidemic complex consisting of Rosuvastatin and Ezetimibe .Hanmi entered the market earlier than its competitors by securing the right to use Ezetimibe from the patent holder MSD and ranks first in the same ingredient market .Hanmi's hypertension complex, Amosartan, was listed at the top of last year with a prescription of ₩74.1 billion .Amosaltan, released in 2009, is a hypertensive complex that combines calcium channel blocker (CCB) 'Amlodipine' and angiotensin II receptor blocker (ARB) 'Losartan'.
- Company
- Novartis holds the most number of drug patents in Korea
- by Kim, Jin-Gu Jan 20, 2020 06:26am
- Sources confirm a pharmaceutical company with the highest number of pharmaceutical patent in Korea is Novartis Korea. The company owns the rights of 153 patents related to total of 29 drug items. While multinational drug companies are mostly dominating the top ten list of patent holders, Hanmi Pharmaceutical with incrementally modified drug (IMD) patents is the only Korean company in the list. On Jan. 17, Daily Pharm analyzed Ministry of Food and Drug Safety’s (MFDS) statistics on patents and found there are overall 1,881 drug patents in effect as of January 2020. The patents affect 1,093 drug items. Top 30 drug patent-holding companies in Korea Currently, 116 companies own at least one or more patents. Novartis Korea own the most with 153 patents related to 79 items. The company’s major line-up consists of Galvus, Galvus Met, Tasigna, Cosentyx, Jakavi, Glivec, Entresto, Afinitor, Stalevo, Exjade, Xolair and more. And recently, patents on Galvus and Galvus Met had been challenged fiercely by Korean pharmaceutical companies. Centering Hanmi Pharmaceutical and Ahn-gook Pharmaceutical, the Norvatis’ patent has been challenged by Korean companies’ defensive confirmation trial for the scope of patent right. The industry expects to see the original’s generics launched by August 2021 at earliest. Janssen Korea takes the second place, but has a significant gap with Novartis. Janssen holds 83 patents for 47 items, including Darzalex, Stelara, Prezista and more. Hanmi Pharmaceutical follows next on the list with 66 patents registered for 43 items. Most of them are IMDs like Amodipin, Amosartan, and Hanmi Flu. The rest of the list includes MSD Korea, GSK Korea, Takeda Pharmaceuticals Korea, Pfizer Pharmaceutical Korea, Korea Boehringer Ingelheim Korea, AstraZeneca Korea, and Bayer Korea. Hanmi Pharmaceutical is the only Korean company in the top-ten list. Expanding out the list down to top 20, there are total seven Korean pharmaceutical companies. LG Chem (27 patents), Chong Kun Dang Pharmaceutical (27 patents), Dong-A ST (24 patents), JW Pharmaceutical (22 patents), Daewoong Pharmaceutical (20 patents), and SK Chemicals (19 patents) have their places in the top 20 list. Interestingly, the top sales revenue list and the top patent-holders list do not match. As of 2018, Yuhan is the top selling Korean pharmaceutical company, but the company sits on the 13th place on the top Korean patent-holding companies’ list. The second top selling company GC Pharma is on the 21st place on the patent-holder’s list. Whereas the top selling global pharmaceutical company Pfizer is actually on the sixth place on the top patent holder’s list. Janssen is within the top ten selling pharmaceutical companies’ list, but it is on the second place for the patent holder’s list. Top 20 patent-holding multinational companies 50 multinational pharmaceutical companies’ patents affect 63.6 percent of drugs in the Korean market. The global companies hold 72.8 percent of all drug patents in Korea, which means each global company owns average of 13.9 patented drugs. Among 66 Korean companies, each one holds average of six patented drugs. However, most of the Korean companies (46 companies) own less than five patented items. 21 companies have only one item patented. Patent-holding ratio of multinational and Korean pharmaceutical companies in Korea As far as patented substance goes, metformin hydrochloride had the most number of related patented drugs with 47 items. Following the list, rosuvastatin calcium (29 drugs), amlodipine besylate (25 drugs), hydrochlorothiazide (20 drugs), losartan potassium (16 drugs), telmisartan (16 drugs), amlodipine camsylate (15 drugs), and pregabalin (15 drugs) have the most number of related patented drugs. Mostly, the patented drugs treat chronic diseases like hypertension and diabetes.
- Company
- Takeda's Kynteles indicated for first-line treatment
- by Eo, Yun-Ho Jan 20, 2020 06:26am
- Kynteles would be rubbing shoulders with tumor necrosis factor-alpha (TNFα)-antagonist in treating ulcerative colitis and Crohn’s disease. Takeda Pharmaceuticals Korea (CEO Moon Hee-seok) official stated on Jan. 15, ulcerative colitis and Crohn’s disease treatment Kynteles (vedolizumab) won Korean Ministry of Food and Drug Safety’s (MFDS) approval on an indication for a first-line treatment. According to the approval, Kynteles would be available from Jan. 15 for prescription on treating patients with ulcerative colitis and Crohn’s Disease after having to fail in remission by conventional treatment (with corticosteroid or immune therapy). This means the treatment can be used, on the same treatment level as TNFα-antagonist and other biological drugs, to treat patients with inflammatory bowel diseases. The two most common forms of inflammatory bowel diseases, ulcerative colitis and Crohn’s disease, tend to relapse and remit repetitively. Studies found half of patients with inflammatory bowel diseases faced limits to their treatment so far having chronic, relapsed or worsened symptoms, damaged digestive systems and induced complications. Besides clinical remission, intestinal mucosal healing is globally emerging as a new treatment target for inflammatory bowel disease. Kynteles is a gut-selective treatment designed to specifically antagonize the α4β7 integrin, a cause of intestinal inflammation, and to inhibit the binding of α4β7 integrin. Unlike existing treatments possibly increasing risk of tuberculosis and infection, Kyntelels’ efficacy as systemic immunosuppressant has not been confirmed. According to GEMINI LTS study result, the vedolizumab drug demonstrated long-term effectiveness and safety profile in patients with ulcerative colitis and Crohn’s disease, observing clinical remission maintained up to 152 weeks. And in Phase 3b VERSIFY study testing the treatment’s efficacy in 101 patients with severe Crohn’s disease, 15 percent and 12 percent of patients treated with Kynteles showed complete mucosal healing and endoscopic remission, respectively. In a recent study, Kynteles demonstrated statistically superior clinical remission compared to conventional TNF-α antagonist. Comparing patient groups either intravenously injected with Kynteles or subcutaneously injected with Humira (adalimumab), VARSITY study found 31.3 percent of Kynteles group reached clinical remission at week 52, but only 22.5 percent of Humira group did. President of Korean Association of the Study of Intestinal Diseases (KASID), Kim Joo Sung claimed, “In Korea as of 2018, over 40,000 people were diagnosed with ulcerative colitis and 20,000 people with Crohn’s disease, and their prevalence rates have been soaring fast lately in Asian region including Korea. As the diseases require long-term treatment, alleviating symptoms are not sufficient, but rather the patients should also improve mucosal healing and treat their inflammatory bowel diseases considering safety profile of drugs.”
- Company
- Samsung BioLogics opens new CDO lab in San Francisco
- by Lee, Seok-Jun Jan 20, 2020 06:25am
- Samsung BioLogics will establish a CDO R&D Lab in San Francisco in the first half of this year. The company is the first US corporation. Samsung BioLogics plans to further expand to other regions of the US and Europe. Samsung Biologics President Tae-han Kim and Vice President John Lim announced the plan at the JP Morgan Biohealth Conference in San Francisco. Tae-han Kim, President & CEO, Samsung BioLogics (left) & Vice President John Lim(Right) President Tae-han Kim shared the business status. President Tae-han Kim said, "We are currently conducting 35 CMO products, 47 product approvals, 42 CDO projects and 10 CRO projects, & expanding our global business with 47 product approvals". As the project accumulates, the plant utilization rate is rising. Kim said, “The first plant is nearing its maximum utilization rate and the second plant is currently in full operation, the third plant has 35% of its production capacity and will raise it to 60% this year”. Vice President John Lim announced the entry into the CDO R&D Lab in San Francisco, USA in 2020. This is to create synergy with customer satisfaction and production base in Korea through overseas expansion. "We are looking into the CDO R&D lab in San Francisco in 2020 and further expansion in other parts of the United States and Europe," said John Lim. He said, “Samsung BioLogics began expanding its value chain to CDO/CRO in 2017, and established a one-stop service from cell line development to clinical material production through sCMO, quality control/analysis, and commercial mass production. Biotech and Big Pharma have more than 9,000 locations".
- Company
- Pfizer's EGFR TKI to compete against Iressa and Giotrif
- by Eo, Yun-Ho Jan 17, 2020 06:27am
- Pfizer Pharmaceutical Korea is stepping into the lung cancer-treating EGFR TKI market. Industry sources reported, Korean health authority is expected to grant approval on Pfizer’s epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Vizimpro (dacomitinib) within the first quarter of the year. Last year, the global company has submitted a marketing approval application. Vizimpro won approvals from the U.S. Food and Drug Administration (FDA) and European Commission in October 2018 and April 2019, respectively. The drug is a first-line target therapy treating patients with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) with confirmed EGFR exon 19 deletion or exon 21 L858R substitution mutations. It is categorized as a second generation therapy like Giotrif (afatinib) by Boehringer Ingel Heim. EGFR TKI products approved in Korea Currently, first generation AstraZeneca’s Iressa (gefitinib) and Roche’s Tarceva (Erlotinib), second generation Giotrif, and third generation AstraZeneca’s Tagrisso (osimertinib) are available for prescription. When the company releases Vizimpro, it would directly compete against Iressa, Tarceva and Giotrif. But the competitor line up would change when Tagrisso is listed as a reimbursed first-line treatment. Considering Vizimpro is a follow-on drug, Pfizer would price the drug comparatively lower and rather aim to receive reimbursement fast. Vizimpro’s efficacy was confirmed in a Phase 3 study, ARCHER 1050. The clinical study compared arms each treated with dacomitinib and AstraZeneca’s first generation medicine Iressa, and observed overall 425 patients with NSCLC. As a result, Vizimpro lowered patients’ hazard ratio 41 percent more than Iressa, whereas median progression-free survival (PFS) in the Vizimpro arm was 14.7 months compared to 9.2 months in the Iressa arm. However, Vizimpro group had more adverse reaction reported. The most common third-level and higher serious adverse reactions were acne (14 percent) and diarrhea (eight percent) in Vizimpro group, and abnormal liver enzyme level (eight percent) in Iressa group. 60 percent of Vizimpro-treated patients had to adjust treatment dose due to the side effects.
- Company
- Nexava’s patent expired, Why generics not released yet?
- by Kim, Jin-Gu Jan 17, 2020 06:24am
- Generics have not appeared even though the patent for hepatocellular carcinoma 'Nexava' (Sorafenib) has expired. Hanmi is reportedly having difficulty in generic development even though it has actively solved the patent problem. In some industries, abandonment is raised. Hanmi is poised to bring it to market as soon as the bioequivalence test and licensing process is completed. According to the pharmaceutical industry on the 14th, Hanmi Pharmaceutical has challenged to develop Nexava alone. The item went to the Supreme Court and worked hard enough to pass the patent. There are three patents on Nexava. Bayer, the original company, has registered patents for materials, crystalline patents, and formulations and uses. Among these, Hanmi has succeeded in overcoming the crystalline patent and the formulation and use patent. In 2015, Hanmi Pharm claimed a negative jurisdiction for judging crystalline patents and an invalidity trial for formulation and use patents. The patent dispute was fierce enough to go to the Supreme Court. In the end, the Supreme Court concluded the dispute over two years on the side of Hanmi Pharm in both patent disputes in 2017. As a result, Nexava-related patents were left with only one patent. The patent even expired this month. The hurdles for generic releases are gone. Nevertheless, the launch of generics for Nexava are still uncertain. As of the 14th, the generics aren’t be identified in the drug product authorization list of the agency. This is an unusual interpretation given that generics are generally released in accordance with the expiration of material patents. It did not pass the bioequivalence test. Hanmi conducted bioequivalence test in August 2015 named Hanmi Sorafenib. As a result, it failed to confirm bioequivalence test. With this, some have raised doubts about whether Hanmi has abandoned its development. Hanmi made it clear that it was not true about abandonment. Hanmi has been on the verge of reviving since March last year. It is reported that the recent recruitment of patients is over. An official from Hanmi said, "We will proceed with the application for approval as the bioequivalence test is completed". According to IQVIA, a pharmaceutical market analyst firm, Nexava's annual sales are ₩26.3 billion (as of 2018). If Hanmi succeeds in launching the generics as planned, it is expected that it will be able to secure a significant portion of Nexava's sales, as it is under exclusive development. So far, only Hanmi has succeeded in avoiding Nexava patents. Yuhan Corporation, JW pharmaceutical, and Ahn-gook Pharmaceutical challenged the patent, but withdrew the patent trial request.
- Company
- Dong-A ST finished Abbvie’s ₩48 billion down payment
- by Lee, Seok-Jun Jan 17, 2020 06:24am
- Dong-A ST completed a 36-month split recognition of the Abbvie technology export contract of $40 million (about ₩48 billion). The 36 months is a period in which the two companies are considering the selection of pipelines. In other words, the preclinical study has countdown on the assumption that the pipeline has been successfully derived. Dong-A ST transferred the technology of MertaK inhibitor DA-4501 in the process of pipelines to Abbvie in December 2016. MerTK inhibitors are a new mechanism of immunological anticancer drugs that inhibit the activity of MerTK (MerTyrosine Kinase) protein and help the immune system. According to the industry on the 15th, Dong-A ST completed the 36-month split recognition of the Abbvie technology export contract by November last year. In the meantime, the $40 million contract has been booked at $ 1.11 million (about ₩1.3 billion) monthly and $3.33 million (about ₩3.8 billion) quarterly. Dong-A ST lost fixed profits after the split recognition. However, additional milestones can be expected as clinical progress Dong-A ST's Abbvie technology export maximum milestone is $ 485 million, excluding the $ 40 million contract. As clinical progress progresses, the inflow of royalties increases. According to the company, there are no milestones for receiving pipelines. After the down payment, the following fees are based on preclinical results. Since then, the milestones will increase in size. An official of Dong-A ST explained, "The Abbvie’s split-up recognition period is the period in which the pipeline is derived, and the pipeline is expected to be derived soon. If successful, it will enter the pre-clinical". The two companies, on the other hand, are obliged to carry out joint development until pre-clinical. For this, Dong-A ST and Abbvie formed Joint Research Committee. Steps after pre-clinical will be carried out by Abbvie alone.
- Company
- BTX market new comers not bothered by legal dispute
- by Kim, Jin-Gu Jan 17, 2020 06:22am
- The Korean botulinum toxin market competition is reaching the peak. While the toxin strain related legal dispute has not yet been fully resolved, more and more companies are latching on to the market. Bio ventures, on top of the large and small-and-medium companies, have announced their plan to join the over-heated competition. On Jan. 13, Ministry of Food and Drug Safety (MFDS) cleared two botulinum toxin items, ‘Bienox’ and ‘Hitox,’ respectively from BNC Korea and BMI Korea. Founded in 2007, BNC Korea specializes in aesthetic plastic surgery medical devices like dermal filler and hyaluronic acid filler. Established in 2005, BMI Korea is the only pharmaceutical company to base in Jeju Island. It has been mainly manufacturing injections for anesthesia and pain. It seems their strategy is to first receive approval as an export product, and to win sales approval in Korea after conducting clinical trial in the future. With the export approval, the companies may export the products overseas without marketing approval in Korea. The strategy has worked for Huons, when its botulinum toxin product first got cleared for export under the name of ‘Hutox’, and received approval for Korean market later under the name of ‘Liztox.’ Including BNS Korea and BMI Korea, now 12 pharmaceutical companies have Korean government-approved botulinum toxin products. The number goes down to eight, excluding importers like Allergan, Merz and Ipsen. The rest of the list consists of Medytox, Hugel, Daewoong Pharmaceutical, Huons, Pharma Research Bio, Chong Kun Dang Pharmaceutical, BNC Korea and BMI Korea, in the order of approval date. Botulinum toxin products approved by MFDS The list expands to 18 companies if companies with botulinum toxin in development are added. All the latecomers are new bio companies, such as Jetema, Protox, Kanzen, Eubiologics, and Inibio. According to sources, Jetema has recently applied for MFDS’ export approval. The company has been approved as a pharmaceutical manufacturing company in January 2019. The purpose of the company seems to be clear and focused on manufacturing botulinum toxin products. On the other hand, Protox completed the construction of its botulinum toxin production facility in Hyangnam Pharmaceutical Industry Cluster in Hwaseong, Gyeonggi Province. The facility has a capacity to manufacture approximately 2.7 million vials a year. The company plans to conduct Phase 1 trial this year on its independently developed product, ‘Protoxin.’ Eubiologics and Inibio had their clinical trial protocols passed in March and December last year, respectively. Kanzen has registered botulinum toxin strain discovered on a snow mountain. Botulinum toxin products in development As a result, an unprecedentedly intense competition is expected to unfold in Korea. Currently, there are about three to seven global pharmaceutical companies supplying botulinum toxin products. Starting from Allergan, Ipsen and Merz, other global companies like Galderma, US WorldMeds, Revance Therapeutics and Lanzhou Bioengineering are in the game. In around 2022 and 2023, at least 14 companies would be competing against each other with 16 items according to the companies’ development plans. As blunt as it is, the competition would inevitably do more damage. The market, once led by Medytox and Hugel, has gotten saturated with Daewoong Pharmaceutical and Huons joining the market. Sources confirmed Medytox and Hugel have stopped growing already. Also the unresolved legal dispute over the source of botulinum toxin strain could be a burden for the new challengers. At the moment, Medytox and Daewoong Pharmaceutical are preceding astronomically expensive litigation on the source of botulinum toxin strain. The litigation would get close the final decision in around June. An insider of the industry commented, “Depending on the final decision, the two companies may proceed with next litigation.”
- Company
- Mabthera anticipating indication on pediatric polyangiitis
- by Eo, Yun-Ho Jan 16, 2020 03:07pm
- MabtheraPharmaceutical industry is expecting anticancer treatment Mabthera to get indicated for treating pediatric patients in Korea. The industry source reported Roche Korea has submitted an indication expansion application to Ministry of Food and Drug Safety (MFDS) for Mabthera (rituximab) to treat 2-year-old and older pediatric patient with granulomatosis with polyangiitis (GPA) and microscopic plyangiitis (MPA). The application was for intravenous administration of Mabthera, and it is expected to get cleared within this year considering general processing period. The two diseases are rare angiitis that flares up inflammation in small vessels and significantly decreases blood volume, resulting in damaging major organs like lung and kidney and affecting skin. In September last year, the U.S. Food and Drug Administration (FDA) has approved the pediatric indication for Mabthera under a priority review with orphan drug designation. The approval was based on Phase 3 study that consisted of 25 patients aged from six to 17 years with the diseases. The clinical trial observed 14 patients achieving remission after six months of Mabthera treatment, and every patient achieving remission after 18 months. During the study, infections, infusion-related reactions and nausea were the most common side effects reported. And also, patients participating in the study with pediatric GPA and MPA have been observed with hypogammaglobulinemia. Indicated not only for treating hematologic cancer, but also for autoimmune conditions like rheumarthritis, Mabthera has formed an approximately five-trillion-won market (according to IQVIA data from 2018) in the U.S. alone. Currently, the treatment has an emerging competition in the U.S. as Pfizer and Korean company Celltrion’s co-marketed biosimilar with expanding indications.
