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- 2026-05-16 04:04:17
- 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.
- Company
- Pfizer's Novasc 10mg packaging will change to 28 tablets
- by Jung, Hye-Jin Jan 16, 2020 06:07am
- Pfizer's Novasc 10mg packaging unit will change from 30 tablets to 28 tablets. In addition, many drugs, including Bayer's antibiotic Avelox and Samjin Pharm's Gelma suspension, were sold out. According to the wholesale industry on the 14th, 30 tablets of Novask tablet 10mg tablet of Korean Pfizer will be discontinued and 28 tablets packaging will be supplied. The only discontinued item is 30 tablets of 10mg, and 30 tablets of 2.5mg, 5mg tablets and 500 tablets of 5mg tablets are supplied unchanged. Due to the delay in global production and supply, 30 tablets packaging of Bayer's Avelox Tablet 400mg is in short supply. Chong Kun Dang, which distributes Avelox, said it will be available by April 20. Samjin Pharmaceutical announced on the 14th that 125 pouch packaging products (25 pouches*5EA) of Gelma Suspension 10g were sold out. The reason for the absence of stock and the timing of resupply were not disclosed. Pfizer's psychoactive drug, Halcion 0.125mg, is also sold out due to a shortage of supplies. The cause is a delay in the supply schedule, which Pfizer expects to be available from March. Allergy medications Montelukast 10mg and Montelukast Chew 5mg and 4mg from Dongkwang Pharm are also in imbalance between supply & demand, and will be supplied again at the end of next month. It will be resupply in mid-March due to the delay. Jeil's 30-pack package of Bondube 60mg for osteoporosis treatment will be resupplyed in mid-March due to delays in product improvement. The packaging of 30 tubes of Ganfort UD 0.4ml, an eye drop solution by Allergan, is also temporarily sold out due to delays in import schedules. It will be resupplyed on February 14.
- Company
- Zejula indicated for late-line therapy on ovarian cancer
- by Eo, Yun-Ho Jan 16, 2020 06:06am
- Anticancer treatment Zejula is now available for a monotherapy prescription on patient with ovarian cancer, who has been treated with fourth-line or later treatment. Takeda Pharmaceuticals Korea (CEO Moon Hee-seok) official stated Ministry of Food and Drug Safety (MFDS) has additionally indicated Zejula’s (niraparib) on Dec. 24 for treating patient with relapsed ovarian cancer, who has been treated for more than third-line treatment. From March last year Zejula, the first poly ADP ribose polymerase (PARP) inhibitor used regardless of BRCA mutation, has been approved in Korea for maintenance treatment of adult patients with recurrent epithelial ovarian cancer (including fallopian tube or primary peritoneal cancer), who are in a complete or partial response to platinum-based chemotherapy. And in December last year, the government granted healthcare reimbursement on the indication. However, the first reimbursed indication was limited to patients with BRCA mutation. By expanding the indication, Zejula is now the only PARP inhibitor in Korea indicated for BRCA mutation-positive patient regardless of platinum sensitivity, or hormone recombination deficiency (HRD)-positive adult patients, who have been treated with third-line plus chemotherapy. The indication expansion was based on an open-label multi-center QUADRA study evaluating the safety and efficacy of Zejula treating adult ovarian cancer patients with a record of third-line plus treatment. Treating HRD-positive platinum-sensitive patient group demonstrated objective response rate (ORR), a primary endpoint of the study, of 24 percent, whereas BRCA mutation-positive platinum-sensitive patient group, BRCA mutation-positive platinum-resistant patient group and BRCA mutation-positive platinum-refractory patient group demonstrated 39 percent, 29 percent and 19 percent, respectively, which confirmed the clinically meaningful benefit of the treatment. The secondary endpoint of the study, median duration of response (mDOR) of 8.3 months was observed in HRD-positive platinum-sensitive patient group. The finding confirmed the treatment’s safety profile can be managed by controlling the treatment dose.
