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- 2026-05-21 00:07:39
- Company
- Chong Kun Dang in talks over approved Xofluza
- by Kim, Jin-Gu Dec 18, 2019 06:25am
- Xofluza (baloxavir), a follow-on drug for influenza patient treating Tamiflu (oseltamivir), has been recently approved the Korean health regulator, and is now in talks with Chong Kun Dang Pharmaceutical about the marketing deal in Korea. Korean Ministry of Food and Drug Safety (MFDS) has granted an approval on commercialization of Roche Korea’s Xofluza in 20 mg and 40 mg dose last month. The Korean industry predicts Chong Kun Dang would highly likely to grab the marketing rights of the flu treatment in Korea. According to a pharmaceutical industry insider on Dec. 16, Roche Korea and Chong Kun Dang are currently in negotiation over commercialization in Korea. Chong Kun Dang signed an exclusive distribution and sales deal on Tamiflu with Roche in 2012. The contract has been maintained to this day. With the long plausible relationship with the Korean company, the multinational company is positively having talks over Xofluza. The two companies had an official statement issued saying “Xofluza’s commercialization deal in Korea is ongoing at the moment. Nothing has been decided, yet”. When they agree on the final terms, the treatment is expected to be launched early next year at earliest, considering preparation time between the approval and actual launch date. Also taking in account of the insurance reimbursement review period, the treatment would join the competition in around next influenza season, either from winter of 2020 or spring of 2021. Xofluza, after its launch, would have to compete against GC Pharma’s Peramiflu, Hanmi Pharmceutical’s Hanmi Flu and other generics. In particular, Xofluza would compete against Peramiflu for the single-dose prescription. The two have contrasting advantages and disadvantages. Both of them are prescribed for a one-dose administration, but Xofluza is orally taken and Peramiflu is administered intravenously. However, Peramiflu has its indication approved for pediatric patients. Xofluza is currently only approved for adult and teenagers older than 12. Administration convenience and pricing are make-or-break factors the competition against generics like Hanmi Flu. Tamiflu and other generics are inconvenient for the patients as they have to be taken orally for five days. Meanwhile, Tamiflu generics in convenient suspension form are also their strength. Moreover, they have the upper hand with an indication for pediatric patients like Peramiflu.
- Product
- “Lipitor not sold out”, Pfizer clarifies rumors
- by Kim JiEun Dec 18, 2019 06:24am
- Rumors of cholesterol lowering treatment Lipitor tablet going out of stock have been spreading throughout major pharmacies, but its company clarified the rumor is false. Pfizer Upjohn Korea on Tuesday told Daily Pharm that the manufacturing of Lipitor 10 mg tablet (28BLP/ 90BLT) has no issue at the moment. The company’s statement was an answer to the recent Lipitor stock-out rumor spreading among pharmacies. Apparently, the talk of Lipitor going out of stock until next year was looming from pharmacists on social media channels and triggered some pharmacies to start hoarding the product. With a temporary spike in order volume, a certain distributor had to notify their salespeople to explain about the situation of pharmaceutical distributors and online shops having scarce stock of the drug to their designated pharmacies. The distributor informed their salespeople that “Lipitor has been sold out due to a baseless false rumor. It has affected all distributors in Korea. As temporary demand in other products has been increasing as well, please visit designated pharmacies to explain the situation”. The whole situation has caught the global company by surprise. The company has been ordinarily manufacturing and supplying the item, when the order has exponentially hiked because of the rumor. Pfizer Upjohn Korea official told, “As of afternoon of Dec. 16, Lipitor 10 mg supply is in a normal state. The company has confirmed Lipitor’s stock in some pharmacies have been sold out. To minimize inconvenience of doctor, pharmacist and patient, the company is in process of studying the origin of the rumor and resolving it”. The company also explained the drug is supplied based on market demand projection and it notifies the public when it predicts drug stock-out from plausible cause. “The company provides products considering a projection based on multiple years of collected market supply and demand data. Accordingly, supply amount is regularly monitored. When the company expects a setback in supply process, the company informs organizations of distributor and pharmacist to minimize turmoil in the market”, the official elaborated. “Pfizer Upjohn Korea would continue to strive for stable supply of drug”, the company official added.
- Company
- Oraxol by Hanmi apply US license
- by An, Kyung-Jin Dec 18, 2019 06:24am
- The commercialization of the anti-cancer drug 'Oraxol', a technology exported by Hanmi, is imminent. Hanmi's US partner Athenex unveiled its Phase III clinical results for patients with metastatic breast cancer and announced its intention to approve the FDA in early next year. Some assessments suggest that some indicators, such as gastrointestinal adverse events, do not meet expectations. ◆Athenex, confirmation of anticancer effect of Phase III clinical trial for oral Paclitaxel Athenex unveiled the results of its Phase III clinical study at the San Antonio Breast Cancer Symposium (SABCS 2019) held in Texas, USA on 13th (local time). This study compares the efficacy and safety of randomly assigned metastatic breast cancer patients enrolled in 45 Latin American clinical trials into Oraxol group or Paclitaxel IV group. Oral test drug 205 mg / m² three times a week, and the control group received 175 mg / m² of Paclitaxel intravenous injection every three weeks, and then confirmed the tumor response through imaging tests. The conference announcement was similar to the topline results that Athenex released in August. According to the Intention to Analyze (ITT), which included those who discontinued or changed the treatment during the clinical trial, the objective response rate (ORR) of the Oraxol group was 35.8% (95 of 265) better tumor suppression effect (P = 0.001) than 23.4% (32 of 137) of the IV group. The median response time was higher in the Oraxol group (27.9 months) than in the Paclitaxel intravenous group (16.9 months), overall survival (median) was also significantly different (P = 0.035) at 27.9 months and 16.9 months respectively. However, the progression-free survival period (median value) was 9.3 months in the group taking Oraxol, which did not show a statistically significant difference from the IV group (8.3 months) (P = 0.077). Oraxol, Phase III Clinical Results (Source: Athenex) 'Oraxol' is a synthetic drug that Hanmi exported to Athenex in the US in 2011. Hanmi Pharmaceutical turned its Paclitaxel injection into oral by applying its own developed ORASCOVERY platform technology. By blocking the membrane transport protein P-glycoprotein (P-gp) that interferes with the oral absorption of anticancer drugs, it is a mechanism to improve the absorption rate has been pointed out as a disadvantage of oral drugs. The Paclitaxel injection, which is the most commonly used for breast cancer treatment, is changed to oral drug, thereby increasing convenience and increasing marketability. It is also meaningful that Hanmi’s ORASCOVERY platform technology has entered commercialization on track. ◆Investment industry, "Effective goal met, but adverse reaction is key" However, the investment industry is disappointing with the results of the Phase III clinical trials. Although the primary efficacy endpoints were met, the safety profile was ambiguous. Shortly after the conference, Athenex shares fell 17 percent. According to the report, the incidence of alopecia and severe neuropathy adverse events was 17% in the Oraxol group, which was lower than 57% in the intravenous group. Severe neuropathy symptoms were also improved in the Oraxol group at 1% and 8%. Toxicity profile was similar. On the other hand, neutropenia, infection, and gastrointestinal adverse events were higher in the Oraxol group. Athenex Based on this three-phase clinical data, Athenex expresses its intention to commercialize the Oraxol in earnest, and the marketability of the Oraxol is expected to be tested. Atenex executives said during the third quarter of last month's results that they are preparing a pre-meeting to submit a new drug application (NDA) for the US Food and Drug Administration (FDA) in the first quarter of next year. He also said he is also considering expanding the range of Oraxol’s use to other carcinomas, including advanced gastric cancer, using anti-PD-1 antibodies such as Keytruda. In addition to Paclitaxel, the company aims to develop oral formulations of various anticancer drugs such as Irinotecan and Eribulin using ORASCOVERY Platform technology. Athenex executives held the conference call related to the announcement of SABCS 2019. He stressed “Oraxol has achieved meaningful results in phase III clinical trials, and this is the first case of Paclitaxel that has been converted to oral to demonstrate anti-cancer effects, and Oraxol is expected to be an important treatment option for breast cancer patients”.
- Policy
- The MFDS plans to collect & test Metformin
- by Lee, Tak-Sun Dec 18, 2019 06:24am
- The Ministry of Food and Drug Safety (the Minister, Eui-Kyung Lee) has decided to collect and inspect commercial distribution items to investigate impurities on Metformin. As a result, the MFDS is preparing a test method with a goal within the year and is conducting a raw material system investigation for the preliminary safety management. The MFDS said it is conducting an impurity investigation on Metformin on the 16th. Prior to this, the Singapore Health Sciences Agency (HSA) announced that it detected and recovered trace amounts of 'N-nitrosodimethylamine (NDMA)' in three out of 46 Metformin-containing products. NDMA is a Group 2A human carcinogen suspected by the World Health Organization (WHO) International Cancer Institute (IARC). The MFDS confirmed that the same products as those recovered in Singapore were not imported in Korea. However, raw materials from the same manufactory used in the medicine are said to have come from Korea. However, even if the raw material of the same manufactory lot may be different because there is not necessarily the risk of problems. First, the MFDS is conducting a systematic investigation of the source (import source) of the use of Metformin-containing medicines in advance of safety management. It also plans to establish a test method for NDMA in metformin within the year. After the test method is established, Metformin raw materials and drug products will be collected and tested as soon as possible. An official from the MFDS said, "We will start collecting products this month and carry out inspections from January next year". Investigations are expected to be conducted first with products that are the same manufacturer as the raw material for products recovered in Singapore. It will be considered whether to expand the survey. This is because the test subjects are so large that Metformin is allowed in 640 items in Korea. An official from the MFDS said, “We will carry out test tests promptly, and we are working closely with regulatory agencies such as the European EMA, the US FDA, and the Japanese PMDA to exchange related information such as the cause of occurrence”. In addition, the MFDS and the Korean Diabetes Association, Metformin is a diabetic drug, and continuous medication is very important for the treatment of diseases. Patients taking Metformin-containing medicines were advised not to stop taking it without consulting their doctor or pharmacist. In the future, if there is a test result exceeding the acceptance criteria, it will immediately notify the health professionals and the public, including medical and pharmacists.
- Company
- Korean companies now having long year-end holiday
- by Lee, Seok-Jun Dec 17, 2019 12:33pm
- The Korean pharmaceutical industry is starting to adopt the long year-end holiday season to wrap up the year around Christmas and to start fresh from the New Year. Boryung Pharmaceutical and other Korean companies are having a long holiday for the first time this year. Multinational pharmaceutical companies are starting their long holiday season soon like they have been for years. Apparently, AbbVie is to have is the longest 18-day holiday season. Daily Pharm surveyed year-end holiday schedules of 40 pharmaceutical companies in Korea, including top 20 Korean companies, 18 global companies, and two pharmaceutical industry organizations—Korea Pharmaceutical and Bio-pharma Manufacturers Association (KPBMA) and Korean Research-based Pharmaceutical Industry Association (KRPIA). Nine out of 20 companies are leaving for the holiday from Dec. 26 to 31. Including public holiday on the Christmas day and the New Year’s day, they are closed for total eight days. The list of companies include GC Pharma, Hanmi Pharmaceutical, Dong-A ST, JW Pharmaceutical, Ildong Pharmaceutical, Boryung Pharmaceutical, Huons, Dongwha Pharmaceutical, and Samjin Pharm. Boryung Pharmaceutical is having their first long-term year-end leave. Five companies including Kwangdong Pharmaceutical, Daewoong Pharmaceutical, Jeil Pharm, Celltrion and Handok’s year-end schedule is to use employee’s individual annual leave. The companies are highly recommending the employees to use the rest of their annual leave. Yuhan is the first to close the office from Dec. 16 to 20. Including the weekends, the companies are on holiday for nine days. But it opens again from Dec. 23 to prep for the next year’s start. Chong Kun Dang Pharmaceutical and Daewon Pharmaceutical have set Dec. 30 and 31 as designated annual leave day. Whereas Ilyang Pharmaceutical and Dongkook Pharmaceutical have designated Dec. 23 and 24 as annual leave day. They took an advantage of weekends and holidays to take a longer holiday. An industry insider commented, “A long year-end holiday season has been a typical system only for multinational companies even until recently, but nowadays Korean companies have implemented the similar system to have refreshing holiday season. Most of them use employee’s annual leave days, but employees can fully enjoy a long holiday with an official corporate holiday season”. Multinational pharmaceutical companies’ long year-end holiday season is not so different from previous years. Among the surveyed multinational companies, AbbVie is having the longest year-end closing. The 18-day leave is to stretch from Dec. 19 to Jan. 5 next year. AbbVie has decided to grant special vacation day on Dec. 30 and 31, and use employee’s annual leaves on other days. The office usually closes on Jan. 2 as it is AbbVie’s foundation day. Pfizer is to close the office from Dec. 17 to the end-of-the-year. Including the New Year’s day, they will be closed for 16 days. AstraZeneca, Boehringer Ingel Heim, Roche, Takeda, Daiichi Sankyo, Sanofi and Amgen are closing around Christmas. Other companies are to use employee’s annual leave for the year-end holiday season.
- Policy
- Why did MFDS release its Metformin self-investigation plan?
- by Lee, Tak-Sun Dec 17, 2019 07:20am
- The Ministry of Food and Drug Safety said on the 16th that it is directly investigating the drug 'Metformin', a drug that has been recovered and detected by carcinogen NDMA (N-nitrosodimethylamine) in Singapore. It was the first time that the MFDS announced its own investigation since the Singapore Health and Science Agency announced the recovery of three Metformin items. The MFDS has said through media coverage that it is investigating the domestic inflow of raw materials used in Singapore's products in question, but the MFDS kept silent about collection and inspection plans for domestic distribution items. Let’s learn about the background of MFDS' silence and the release of Metformin's own investigation through a press release. Public opinion has changed, ordered from the Diabetes Association The MFDS released a press release on the 16th, is currently preparing a test method for Metformin formulations, and is conducting a systematic survey on domestic distribution items to identify the source of raw materials. In addition, as soon as the test method was prepared, the MFDS added that they plans to collect and inspect domestic distribution items. In fact, the MFDS has not said that they will not directly conduct an investigation into Metformin's impurities. Nor did they instruct the vendor to do the test autonomously. However, as part of the follow-up measures of Ranitidine and Nizatidine, the press release and public hearings revealed that companies should directly investigate raw materials and finished products that are likely to cause impurities. Some companies have conducted their own tests. Some expressed suspicion that the MFDS was not actively involved in collection and inspection, as opposed to when NDMA problems were raised in Valsartan or Ranitidine. Indeed, the Korean Diabetes Association, which consists of domestic diabetic doctors on the 13th, said, "There is no official announcement whether the raw materials of the company in question were imported to Korea". The Society stressed that the MFDS should address the public's concerns through direct investigations. The Diabetes Society's point was enough to raise suspicion that the MFDS remained a mere spectator. An official from the industry said, “If the MFDS conducted a survey of domestic distribution items based on Singapore collection only when the impurity risks of Metformin preparations were not verified, it would have increased public anxiety, however, on the contrary, it seems to have disclosed its own research plan immediately after pointing out that it should actively take the measures to resolve the public unrest”. Raw material check… increased need for recovery investigation Although it did not appear in the press release distributed on the 16th, it is confirmed that the drug substance imported from Singapore is met with the same drug substance as the Metformin preparation recovered in Singapore. Earlier, the MFDS said that there was no inflow of finished products in Korea, and that it was checking whether the drug substance was imported. The fact that the MFDS conducted a systematic investigation to identify drug substance manufacturers for Metformin ingredients and finished drugs in Korea was influenced by the inflow of ingredients from the same factories as those of Singapore. Therefore, the necessity of checking the raw materials through the systematic investigation, collecting them directly, and increasing the need for self-investigation was increased. However, an official of the MFDS said, “Even if the raw materials are the same, there is no risk because the production lot (process) may be different”. also added “there is no intention to select the raw materials in question because the systematic survey is to investigate the source of all distribution items”. However, it is highly likely that the target of the first collection, inspection planned by MFDS will be the same raw material manufacturer as the recalled product in Singapore. If the risk is identified, the collection and inspection can be extended, otherwise the case can be closed. The MFDS also recognizes the limitation of recovery and investigation of all items. Metformin is a multi-frequency prescription drug that is used as the first-line drug for type 2 diabetes treatment, and this is because 640 domestic licensed items are available. The MFDS expects to investigate domestic distribution items as early as January next year. As such, collection of some distribution items is highly likely to begin this month. The MFDS' full-fledged investigation does not increase the risk of Metformin. The MFDS said in a press release on the 16th. that, among other things, patients taking Metformin-containing medicines should not stop taking it without consulting their MDs or pharmacists.
- Company
- Champix, conclusion of patent disputes imminent
- by Kim, Jin-Gu Dec 17, 2019 06:34am
- A patent dispute over the Champix(Vareniclin) marks the end. The Patent Court has announced that it will issue a judgment on a patent dispute related to the Champix on the 20th , 4 days later. The result of the Champix patent dispute attracted interest in that it could see the future of domestic salt-modifying drugs after the so-called ‘Solifenacin decision’ earlier this year The legal disputes between the two sides were so intense that the court would postpone the sentence four times. The ruling, originally scheduled for February, was postponed for four months, from May to August to October to December. The jurisdiction of the judiciary is also a matter of how deep. The ruling of the patent court is expected to be applied as a definitive ruling. This is because the Supreme Court's appeal is unlikely, as the expiration date of the material patent is almost imminent. ◆Patent Judge sided with generic company, Pfizer appeals In September 2016, more than 20 domestic companies, including Hanmi Pharmaceuticals, filed a patent dispute with Pfizer. Domestic companies tried to speed up the launch of generics with the strategy of “avoiding patents with salt changes.” It is a strategy that avoids the extended duration of material patents by developing salt-changing generics and raising passive judgments on the scope of rights. The Patent Judge, the first case of a patent dispute, raised the hands of domestic companies. Based on this, domestic companies have launched salt-modifying drugs since last November. Pfizer dissatisfied with the decision of the Judge. The company filed a lawsuit with the Patent Court asking to cancel the decision. The ruling on the lawsuit is sentenced on the 20th. ◆Interpretation over Supreme Court's decision to Solifenacin. During the second trial over Champix, a ruling was imposed elsewhere that would have a modest impact on the case. It was a Solifenacin decision issued by the Supreme Court in January this year. The Supreme Court sided with the original company, Astellas, in a salt-altering patent dispute between the original company and the generic company over Solifenacin, an overactive bladder treatment. The key point of the ruling was that ‘the salt-modified product and the original product had substantially the same active ingredients, therapeutic effects, and uses, and those skilled in the art could easily change the salt’. Interpretations were mixed with this ruling. Pfizer and other originals interpreted the Supreme Court as setting a case for the salt change, which has been the main patent evasion strategy of domestic companies. Of course, the case is expected to affect the results of the Champions suit. On the other hand, some domestic companies draw a line that the case of Solifenacin salt-modifying drug and the Champix salt-modifying drug, which were previously lost, is quite different. They explain that the 'substantial identity' that has been crucial in the Solifenacin decision is a separate part of the decision. They also argues that there is a difference in the ease of realization of technology by trade technicians. ◆If a domestic company loses, 'Change salt patent avoidance' strategy useless The patent court's decision will act as a measure of whether to avoid the patent of salt-modified products in the future. If the patent court raises Pfizer's hand in accordance with the Supreme Court case, domestic companies will not be able to use the patent evasion strategy by changing the salt. On the other hand, if the patent court raises the hands of domestic companies separately from the Soliphenacin case, the avoidance of salt-changing patents by domestic companies is likely to continue strategic vitality. A legal personnel said, “At present, the patent court is expected to apply Solvenasin's judgment as a precedent and side with Pfizer, however, as domestic companies insist, there is some possibility of judging the Solifenacin case and the Champix case separately. Either way, it will have a big impact on our strategy for avoiding salt modifications in the future”. ◆Material patent expires after 7 months, Less possibility of 3 trial appeals On the other hand, even if the patent court raises Pfizer's hand, there is a possibility that domestic companies are unlikely to lead the case to the Supreme Court. This is because the champix material patent expiration is shortly until July 19 next year. Given the time it takes to appeal after the Supreme Court appeals, it is likely that the avoidance of the extended patent duration, which was the original purpose of the patent dispute, has already been achieved. In addition, as domestic sales of Champix have been plunging recently, domestic companies' economic incentives have weakened significantly. According to drug research firm IQVIA, Champix's 3Q revenue was ₩5.7 billion, down 46% from ₩10.6 billion a year earlier. It is a quarter compared to the peak season, ₩21.4 billion in the first quarter 2017. An official in the pharmaceutical industry said, "With a huge drop in sales of successful successes, we know that many pharmaceutical companies have decided to stop the release of Champix salt-modifying drugs regardless of the Soliphenacin case." Champix
- Opinion
- [Column] Self-injectable drug abuse, is SPD the answer?
- by Kim, Jung-Ju Dec 17, 2019 01:40am
- Self-injectable obesity treatment Saxenda has been under fire constantly, because the obesity treatment has been abused as a weight management injection generating not only safety concerns but also questionable profit for the interest group. Apparently, the government said it would provide answer to it in November. Some likely suggestions are individual unit packaging and separation of prescription and dispensing (SPD) system. Undue profit generated from abusing Saxenda? Demands for Saxenda has soared when the words got out that the injection is great option for controlling obesity. Accordingly, frequency of prescription and administration showed steep growth since then. However, it is questionable if the users in need of Saxenda are taking appropriate procedure to acquire the treatment at a moderate price. Before a medical profession makes a decision on the necessity of Saxenda administration and dose, user’s demand can make decisions first. As a result, inappropriate prescription of the injection raises concern of adverse reaction and safety. Other than the user’s demand, it also has been meddled with prescriber’s interest in profit. Abnormal amount of financial profit has been generated when prescribing and dispensing the injection, and such push in profitability has been pointed out as a reason for the abuse. Also it is problematic that some of the healthcare institutes and drug distributors are illegally supplying the treatment for the sake of financial gain. Besides making illegal profit, illegal supply of drug could bring serious safety issues. Is Saxenda abuse preventable? Plenty of reasons can be suggested for the abuse. But the user’s perception is the biggest reason. Drug users seeing Saxenda as a weight loss tool for esthetic purpose, rather than a health condition treatment, is one of the main reasons. And doctor’s perception is as problematic. The doctors are the ones to judge the necessity of the treatment use, and a drug prescription and frequency are decided by them as well. The doctor could be prescribing the treatment to the users to increase patient visit frequencies and profit. The user’s abuse can be shifted or prevented by educating and raising awareness of the risk. But doctors need more than a mere training and public service announcement; they need proper regulatory management. The health regulator could intervene doctors with insurance-covered medical service fee review, and pharmacist with the SPD system. Illegal drug supply can worsen the situation and its severity level. Countermeasure on illegal distribution is necessary not only to prevent drug abuse, but also to secure the order in distribution process and to stabilize medical expenditure in the National Health Insurance. Is SPD the answer to prevent self-injectable drug abuse? There are a number of suggestions to prevent drug abuse. Preventing and managing drug abusing by changing the perceptions of user and prescriber has limitations. This is why the regulatory management is needed. Besides the review procedure of insurance-covered medical service fee, the regulator could take account of SPD system as one of options for the regulatory management. The purpose of SPD system is to appropriately integrate economic feasibility and safety of drug use. Moderate use of drug consists of economic feasibility, safety and convenience. And it is the reason the injection was exempted from the SPD system. If an injection were to be dispensed at a pharmacy, the user would have to take it to a healthcare institute to get a shot. But self-injection is an exception and it can be shot either by a medical profession or the user themselves. However, the dual option of administration has become a loophole and it has created a side effect of drug abuse. Therefore, the regulator should positively consider applying SPD system on self-injectable items as well. The treatment was labeled ‘self-injectable’ for the sake of convenience, given the safety is guaranteed. To keep safety and economic feasibility from drug abuse, a handful of drug users should deal with inconvenience of administering the injection at a healthcare institute. The SPD system is not the only measure to prevent and manage self-injectable drug abuse. The government and insurer should endeavor to educate users and prescribers to change their drug use behaviors, while regulatory amendments on review and evaluation, and illegal distribution management are made, simultaneously. The interest group may additionally demand for increased dispensing fee and other means of compensation for SPD. But we should count on the interest groups to logically and reasonably handle the situation.
- Company
- Venture capital investment on bio sector breaks record again
- by Kim, Jin-Gu Dec 16, 2019 10:55pm
- The new investment volume in pharmaceutical and bio industry is expected to mark the highest figure in the history, despite multiple risks occurred in the year. Following last year’s record-breaking volume, this year’s investment volume is to break the last year’s record. Korean Venture Capital Association (KVCA) recently published a Venture Capital Market Brief, as of October 2019. The report found the accumulated new investment volume all across industries reached 3.52 trillion won until the October. Apparently, pharmaceutical, bio and medical sector marked the highest ratio of the entire volume. The sector received investment of 984.1 billion won as of October, taking up about 27.9 percent of the total accumulated investment volume. Last year alone, the sector’s investment volume surpassed 841.7 billion won. Following after the top invested sector, the ICT service sector was invested with 782.5 billion won (22.2 percent) showing a gap of 200 billion won with the top sector. Based on the trend, the pharmaceutical, bio and medical sector’s new investment volume in the year is expected to exceed one trillion won for the first time in the history. After placing itself on the top spot last year, the pharmaceutical, bio and medical sector’s new investment volume has been widening the gap between the second place. The sector actually outperformed itself despite a series of fallouts in the year, like revoked approval on Kolon Life Science’ Invossa-K, and failed Phase 3 trials by SillaJen, Helixmith and HLB. KVCA reported 17 out of 21 special technology listing cases were from the pharmaceutical, bio and medical sector. 11 companies from the sector either have already been listed or are to be listed until the end of the year. The association official explained the background of skewed new investment volume and said “Ever since the special technology listing system was implemented from 2005, the pharmaceutical, bio and medical industry’s share of the overall special technology listing has been the biggest at 78.6 percent”.
- Company
- Huons, challenges localization of Hyaluronidase
- by Lee, Seok-Jun Dec 16, 2019 10:55pm
- Huons Group will challenge the global hyaluronidase market worth ₩3 trillion. HuonsLab, a bio research and development company specializing in Huons Group, announced on 16th that it has signed a commissioned research agreement contract with Panzen, a cell line development company, to develop ‘human gene recombinant hyaluronidase’ cell line development and production process development. Panzen, founded in 1999 is engaged in research and development of biopharmaceutical products at home and abroad, including recombinant cell lines and process development. This year, Korea's own biosimilar anemia treatment (EPO) 'Panpotin' was approved in Korea. Hyaluronidase is a recombinant enzyme protein that breaks down hyaluronic acid and is used as a drug diffusion agent. Hyaluronidase has been recently developed to increase the use of Hyaluronic acid fillers for cosmetic purposes, and to increase drug delivery ability in accordance with the trend of developing antibody treatment or protein drugs subcutaneously rather than intravenously. According to GosReports, the global market for hyaluronidase is estimated to be ₩2.70 trillion by 2020. Huon's Lab challenges the localization of human genetic recombinant hyaluronidase. Huon’s Lab plans to establish a development system from the development of human gene recombinant hyaluronidase cell line with Panzen, which has the know-how and technology for the development of recombinant protein-producing cell line and process development. “We are expanding our bio business at the group level to lead the global healthcare market” said Wan-seop Kim, Huon's CEO. "Recombinant human hyaluronidase is an important technology that can be used in various therapeutics. If successful, it can be competitive in the global biologics technology market.".
