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- 2026-05-21 02:27:36
- Company
- Big5 hospitals adds Glead’s new HIV option Biktarvy
- by Eo, Yun-Ho Nov 24, 2019 09:58pm
- Glead’s new HIV combination drug, Biktarvy is landing its code on tertiary hospital’s prescription list. According to pharmaceutical industry source, Biktarvy has been passed by drug committee (DC) at the Big Five tertiary hospitals in Korea, including Seoul National University Hospital, Samsung Seoul Medical Center, Severance Hospital and others, after the drug passed the insurance listing in July. The main active agent of Biktarvy, bictegravir has been evaluated as a powerful second generation integrase inhibitor that displays a high resistance barrier lowering the risk of developing resistance. Tenofovir alafenamide is also a nucleoside reverse transcriptase inhibitor (NRTI) backbone that shows improved safety profile of tenofovir disoproxil fumarate (TDF). Biktarvy does not require HLA-B*5701 genetic screening and it is able to start treatment fast as it does not have restriction on patients’ viral load or CD4 count. The treatment regimen is an orally taken once-daily tablet, and a patient can take the tablet regardless of food intake. Biktarvy has high barrier to resistance, and it enhanced patient’s administration convenience presenting the smallest size of tablet among three-drug combination drug on HIV infection. Gilead confirmed Biktarvy’s safety and efficacy in four of Phase 3 clinical studies --Study 1489, Study 1490, Study 1844, and Study 1878-- on adult patients with HIV infection who had or not had antiretroviral treatment,. Professor Kim Yeon-Sook of virology department at Chungnam University Hospital explained, “The median age of HIV-infected patients who received antiretroviral treatment has reached 48. HIV infection accelerates development of renal, cardiovascular system, hepatic, bone, neurological and cancer diseases, as the therapy puts pressure on certain aging process.” “While the overall population’s number of death by cardiovascular disease has been going down, the number of death by cardiovascular disease in patients with HIV infection has gone up from seven percent to 13 percent. To reduce the risk of cardiovascular disease in HIV-infected patient, blood pressure and lipid managements are needed,” the professor added. In Study 1844 that compared 563 adult patients with HIV-1, who have undergone antiretroviral therapy for at least three months, the participants in respective arms were treated with ABC, DTG, 3TC and Biktarvy. The result found only 1 percent of 282 patients who switched to Biktarvy had virological failure at 48 weeks. The treatment arm demonstrated noninferior efficacy compared to ABC, DTG and 3TC arms (n=281), as the 94 percent of Biktarvy arm maintained virologic suppression. In both Study 1844 and Study 1878 of 48-week Phase 3 clinical trials, Biktarvy demonstrated no case of emergent drug resistance.
- Policy
- Background of reimbursement standards enhancement of Avodart
- by Lee, Hye-Kyung Nov 24, 2019 09:57pm
- Starting this month, the 5α-reductase inhibitors (5ARI), reimburesement standards of Pinagren tablets 5mg (Finasteride) and Avodart 0.5mg (Dutasteride), which are used to treat prostate enlargement and hair loss, will be strengthened. The Ministry of Health and Welfare has decided to reimbursement benefits when it is administered to 'positive prostate hyperplasia' among the permission of Pinagren and Avodart if both conditions are met. The conditions are as follows: ▲ more than 8 points of IPSS (International Prostate Symptom Score) ▲ Prostate size more than 30ml by ultrasound test or, if the rectal balance test showed moderate or more benign prostatic hyperplasia or serum seroprostate-specific antigen (PSA) levels exceeded 1.4ng/ml. In this regard, the Health Insurance Review and Assessment Service released a question and answer on the establishment of 5ARI reimbursement standards on the 5th and explained the background of strengthening the reimbursement standards of the two drugs. HIRA concluded that there is room to interfere with the correct interpretation of serum PSA level when serum PSA levels were decreased and used for early diagnosis of prostate cancer through taking 5ARI in the process of reviewing textbooks, clinical guidelines, and related opinions from the Korean Academy of Societies. The clinical literature also showed an increased probability of detecting high-risk prostate cancer in the 5ARI-treated patients, and HIRA said it has established a 5ARI reimbursement standards in consultation with relevant societies and associations to encourage the safe use of 5ARI. In addition, HIRA expected that problems such as decreased serum PSA levels and early diagnosis of prostate cancer related to 5ARI administration would be the same when administered for the purpose of treating male hair loss. HIRA explained that it is desirable to consult in a medical association or society considering that these male hair loss medicines are non reimbursement. The new reimbursement criterion 'must meet both conditions' means the condition at the start of 5ARI administration to benign prostatic hyperplasia. This condition was set in consideration of the clinical guidelines for benign prostatic hyperplasia published by a large group of experts (EAU, AUA, NICE, and Korean Urology Association). Excluded country guidelines suggest that the target of 5ARI administration are patients with a prostate size of 30-40ml or more. The related society suggested that 'more than 25-30 g of large prostate size' could be defined as 'more than moderate benign prostatic hyperplasia' There was also a description of the reimbursement condition that, during the administration of Pinagren and Avodart with both of the conditions, the PSA test should be performed at least once every 12 months to evaluate and record the value. HIRA said, "Because benign prostatic hyperplasia is common in men over 40 years old, When diagnosed with benign prostatic hyperplasia at this age, the experts’ opionion that regular assessment of the patient's condition through PSA testing is essential for early diagnosis of prostate cancer was reflected. However, the purpose of 5ARI treatment is to reduce prostate size and lower urinary tract symptom. Decreased serum PSA levels do not serve the purpose of treating benign prostatic hyperplasia, and sustained administration of 5ARI is possible even if PSA levels decrease during 5ARI administration. HIRA said, “In order to respect the autonomy of medical care, the inspection was made as a recommendation, not as a mandatory recommendation.” Patients who were diagnosed with benign prostatic hyperplasia prior to the establishment of the reimbursement standard and who received 5ARI may continue to receive the reimbursement even if they do not meet the two conditions. In the guidelines related to benign prostatic hyperplasia, Pinagren and Avodart are classified as 5ARI without classification according to the ingredients, and the same contents are mentioned. Both ingredients are considered reimbursement if they meet the conditions at the beginning of the administration under the reimbursement standard and alternative administration is possible.
- Company
- Localization of Korean pharmaceuticals in Vietnam is pouring
- by Nho, Byung Chul Nov 22, 2019 06:32am
- Recently, listed pharmaceutical companies are stepping up their efforts to localize Vietnam, which has been spotlighted as a Pharmerging market. Pharmaceutical companies investing in Vietnam include Chong Kun Dang (local branch), JW Pharmaceuticals(acquired Euvipharm), Korea United Pharm. Inc. (local plant), Ctcbio (joint plant),Shin Poong Pharm. Co.,LTD.,(Shin Poong Daewoo Vietnam Pharma), Seoheung Capsules (plant / corporation). The Vietnamese market is attracting attention because of: ▲ High growth potential due to population increase ▲ Generic consumption increase ▲ Specialty drug market expansion due to the aging / chronic diseases increase ▲ High investment refund due to continuous regulatory reform and FOL reduction Can be mentioned. As of 2018, the Vietnamese pharmaceutical market is estimated at ₩7 trillion, of which imports amount to ₩3.30trillion. Other than this, ₩3,6 trillion is the local production scale. Pharmaceutical spending per person is ₩71,000 per year, and it is gradually increasing. Exports are still weak at around ₩ 120billion. By product, the ETC market is about three times larger than OTC and occupies about 75% of the total market. The major importers of pharmaceuticals are European countries such as France (11.4%), Germany (11%), Switzerland (6.7%), Italy (6.7%), UK (4.8%) and Spain (2.8%). India and Korea are representative among Asian countries In particular, Vietnam's pharmaceutical market has high growth potential, It should not be overlooked where the entry of foreign companies is very difficult. The Vietnamese government considers the distribution of medicines to be directly related to national health and national security, and sets high barriers to entry into the Vietnamese pharmaceutical market for foreign companies. In particular, foreigners are not allowed to distribute or sell medicines in Vietnam For foreign companies to distribute and sell medicines in Vietnam, it is possible only through local agents and distributors Drug categorization of bidding for supply of drugs for public health facilities The bidding policy for the supply of medicines for public medical facilities is also worth noting. Vietnam bids on threeparts about generics, originals, and oriental pharmaceuticals in the public health sector. In the case of fiercely competitive generic drugs, bidding companies are divided into 5 groups, and since 1st and 2nd groups have high standards, it is difficult for Vietnamese companies to participate, so foreign pharmaceutical companies belonging to 1st and 2nd groups are advantageous for bidding competition. .Recently, Vietnamese pharmaceutical companies are increasing their investment in technology development to prepare for the increase in imported drugs .The Vietnam market competition is expected to increase due to Vietnam's imports of medicines from the entry into force of the CPTPP and the EU-Vietnam FTA .The removal of the foreign equity cap by local pharmaceutical companies valued a good thing .Vietnam's largest pharmaceutical company DHG (DHG Pharmaceutical Company) officially announced on its website in July 2018 that it will eliminate the foreign ownership limit (FOL) and allow up to 100% .Trapaco also said it plans to eliminate the foreign ownership limit, and Domesco (DMC), the third-largest pharmaceutical company, already owns more than 50% of Chile's Abbott (US Abbott subsidiary) .One of the reasons why Vietnam's major pharmaceutical companies remove foreign ownership limit is to increase R & D investment through foreign investment and gain an edge in the fierce market competition .Vietnam's No .1 pharmaceutical market leader is DHG, with sales of ₩210 billion as of 2017 .The head office is located in Can Tho, South Vietnam .Along with domestic sales, the company exports products to 13 countries including Ukraine, Romania, Myanmar, Russia, Mongolia, Cambodia, Laos and Singapore .In addition to over-the-counter drugs, the company also produces health functional food and attracted ₩120 billion in investment from Taisho Group, Japan's top five pharmaceutical company, in April 2019 .It is also partnering with Vinamilk, Vietnam's largest dairy company, to expand health functional food .Trapaco, the No .2 company, has sales of ₩100 billion and is building a portfolio of all areas including professional, general and health functional food .Another unique feature is having three production plants that meet GMP standards Daewoong Pharmaceuticals is participating in management through equity investment, and it is believed that it is cooperating in various fields, including local production, distribution, sales, business, and bidding .Recently, Vietnam's major companies are actively investing in the retail pharmaceutical distribution market .As a result, Vietnamese pharmacies are gradually transforming into modern distribution channels .In April 2018, Vietnam's No.1 Vin Group announced its entry into the pharmaceutical industry, and in November of the same year, it launched the retail pharmacy brand 'VinFa' in Hanoi and established VinFa Drug Research and Production Center in Bac Ninh province in northern Vietnam .. Vietnam's leading electronics retailers, Mobile World and FPT Retail, also entered the pharmaceutical market through a stake acquisition. Mobile World acquired a 40% stake in Phuc An Khang, a local pharmacy chain, and FPT Retail also acquired Long Chau pharmacy chain and established FPT Long Chau Pharmaceutical JSC (FPT Pharma). Pharmacity, one of Vietnam's leading drugstores, expands its distribution network to major Vietnamese cities such as Ho Chi Minh City, Binh Duong, Can Tho and Hanoi, increasing the number of stores to 196 in June 2019, making it one of the largest pharmacy chain stores in Vietnam. Pharma City plans to increase the number of stores across Vietnam to over 1000 by 2021. Meanwhile, the number of Vietnamese pharmacies is about 57,000, most of them in small families, and the proportion of modern retail channels is only 1.5% of the total.
- Policy
- IMD of Januvia approved, launching scheduled for Sep 2023
- by Lee, Tak-Sun Nov 22, 2019 06:32am
- The salt-modifying drug of Janivia (Sitagliptin Phosphate Hydrate, MSD Korea), which has a high share in the diabetes treatment market as a DPP-4 inhibitor was approved for the first time. This is Januritin alpha 100mg in Daewon pharmaceuticals. MFDS approved the marketing of Januritin alpha on the 19th as drug requiring the safety/efficacy review data submission. Januvia is a big drug with an outpatient prescription of ₩43.3 billion last year. In addition, Janumet, which combines Sitagliptin phosphate hydrate and Metformin hydrochloride, was the best out of diabetic medicine last year, with ₩ 69.4 billion in outpatient prescription sales. Of course, domestic latecomers are highly interested in entering the market. As a result of the development of late-release drugs, 149 cases of Sitagliptin drugs in domestic pharmaceutical companies were approved. The patent challenge also eliminated the patent for salts and hydrates in Januvia. At this time, 55 items that succeeded in patent challenge and first applied for permission obtained exclusivity for generics from Sep 2 2023 until June 1 2024, when the substance patent was terminated 'Januritin tablet 100mg', generic for Januvia and 'Januricombi', generic for Janumet in Daewon Pharmaceutical were also approved in Aug 2015, but did not obtain exclusivity for generics. However, with the initial approval of IMD, the company laid the foundation to enter the market even during the ban on exclusivity of generics. Januritin alpha in Daewon Pharmaceuticals is the first component of Sitagliptin hydrochloride in Korea. It is IMD(incrementally modified drug) synthesized from Januvia phosphate to hydrochloride. As long as there is no same ingredient, it is expected to be available for sale after Sept 2 2023, when the Zanubia material patent is terminated. Existing licensed products are 'Sitagliptin hydrochloride monohydrate with the same ingredients as Januvia or Sitagliptin hydrochloride '' without hydrates. A total of 55 items were approved for Sitagliptin hydrochloride. Attempts have been made to avoid material patents in Januvia. But in last September, patent tribunal dismissed the claim of a domestic pharmaceutical company. Domestic pharmaceutical companies tried to neutralize about 1 year extension to the substance patent as a salt-modified or hydrate-modified drug, but patent tribunal did not accept it. In last January, the Supreme Court ruled that the salt-changing drug also falls within the scope of the extended patent for substance. If the material patent challenge was successful, the launch of the late drug could be after July 5 2022. Currently, however, the patent is blocked, so the late-release drug of Januvia will have to wait another four years. It is the woe of a late comer.
- Company
- Teva-Handok turns around and readies CNS for next year
- by Eo, Yun-Ho Nov 22, 2019 06:32am
- Teva-Handok is shooting for business expansion as it scores a turnaround. One of the most prominent multinational pharmaceutical companies, Israel-based Teva was the talk of the year 2013 in Korean pharmaceutical industry when it entered into a joint venture with a Korean pharmaceutical company, Handok. But, Teva-Handok’s performance was unexpectedly underwhelming, and for a while it has been operating in the red. Among all the other factors, Teva took a risk of operating new drug-centered portfolio, despite the new launch in the market takes time. In fact, 70 to 75 percent of Teva-Handok’s sales were from original items, and by 2018, it turned around as it planned with surge of sales in major new drugs, such as Parkin’s disease treatment Azilect, an opioid agonist for breakthrough pain in cancer Fentora, prolonged neutropenia treatment Lonquex, and severe asthma treatment Cinqair. ◆Teva-Handok’s successful turnaround: Teva-Handok, based on the successful turnaround, is currently operating four business sectors consisting of central nervous system (CNS), anticancer, primary care and respiratory. Above all, CNS disease treatments have been the star of the company leveraging Teva-Handok’s notable growth. Besides multiple sclerosis treatment Copaxone and Parkinson’s disease treatment Azilect, narcolepsy treatment Nuvigil launched September last year propelled the company’s expansion. Nuvigil, a new comer in the Korean narcolepsy treatment market after 15 years, is made of armodafinil, an R-enantiomer of modafinil. It shares same administration with modafinil, but armodafinil’s effect lasts longer. As narcolepsy’s major symptom is excessive daytime sleepiness, prolonged duration of effect could be a deciding factor for patients, who need to be active during the day. Launched in September last year, Nuvigil landed code-in deals at major tertiary hospitals and heightened expectation for next year’s sales growth. ◆ Future plan to reinforce CNS pipelines: Teva-Handok’s CNS portfolio build up plan for next year is to maintain the existing product’s stabilized position in respective markets, and also to rapidly grow new drugs after their launch in Korea next year. The new emerging stars are Huntington’s disease and tardive dyskinesia treatment deutetrabenazine (Austedo, trade name in the U.S.), and new migraine preventive drug, fremanezumab (Ajovy, trade name in the U.S. and EU). Duetetrabenazine, developed by Teva, is a new treatment option approved by the U.S. Food and Drug Administration (FDA) for chorea in Huntington’s disease patients or antipsychotic-induced tardive dyskinesia patients, who did not have a proper treatment option to date. Teva-Handok is currently busy preparing for duetetrabenazine’s release in Korea as Korean Ministry of Food and Drug Safety (MFDS) designated the medicine as an orphan drug for chorea in Huntington’s disease in last May. Fremanezumab is a new migraine-prevention medicine in recently emerging anti-CGRP class. Within the same class, the new medicine is the only option to provide quarterly or monthly choice of administration. So the company is expected to emphasize the administration convenience when promoting the follow-on drug in migraine treatment market for adults in Korea. “Teva-Handok’s mission is to provide as much benefit as possible to many more patients. Instead of strategically segregating new drug and generic lineup, the company stuck to a pipeline portfolio building to target patient’s unmet needs, and also steadily generated expected level of performance. And next year, in particular, the company’s distinctive pipeline in CNS sector would generate even more remarkable results”, the company official stated.
- Policy
- NHIS collected 440 million won for valsartan indemnity
- by Lee, Hye-Kyung Nov 21, 2019 11:40pm
- Only 21.5 percent of pharmaceutical companies have paid the charged indemnity on valsartan damage. Report on ‘Valsartan related Indemnity Claim and Collection Status’ provided by National Health Insurance Service (NHIS) to Democratic Party Lawmaker Nam In-Soon stated the government agency has charged 69 pharmaceutical companies 2.03 billion won as indemnity for additional National Health Insurance expenditure made. However, only 26 out of 69 of them, or 21.5 percent, have paid 436 million won to the government. NHIS announced it spent about 2.03 billion won the agency was not liable for, due to the drug exchange order on already dispensed valsartan medicines last year. The amount consists of 964 million won for diagnosing 109,967 patients, and 1.07 billion won for dispensing other option of treatment to 133,947 patients. Accordingly, the agency charged indemnity for the additional expenditure against 69 pharmaceutical companies on Sept. 25. The first payment deadline was on Oct. 10, but the initial collection rate reached about 4.8 percent. After the second deadline on Oct. 31, total of 26 pharmaceutical companies paid 21.5 percent of the charged indemnity. “Based on external legal consulting, pharmaceutical manufacturers had a fault in safety of manufactured products. On the grounds of product defect as stated in the Product Liability Act, the government claiming for damages was confirmed legitimate. The agency is considering on filing a litigation case worth 1.59 billion won against 43 companies for the unpaid indemnity payment”, NHIS official explained. Meanwhile, pharmaceutical companies with the unpaid due are reportedly considering on taking a joint legal action or litigation to prove absence of legal liability, when NHIS files for damage suit.
- Company
- AstraZeneca takes back local sales from GC and Daewoong
- by Eo, Yun-Ho Nov 21, 2019 11:40pm
- AstraZeneca is taking back some local sales rights from GC Pharma and Daewoong Pharmaceutical. According to pharmaceutical industry source on Nov. 1, AstraZeneca Korea has recently decided to retrieve local sales and distribution rights of a high blood pressure treatment, Atacand (candesartan) from GC Pharma, and of chronic obstructive pulmonary disease (COPD) treatment, Eklira (aclidinium) and Duaklir (formoterol and aclidinium) from Daewoong Pharmaceutical. So from next year at latest, AstraZeneca would directly operate marketing and sales of the three items in Korea. Cardiovascular, Renal and Metabolism (CVRM) Department, currently responsible for antidiabetic treatment Farxiga (dapagliflozin), would probably take in Atacand, and Respiratory Department with Daxas (roflumilast) and Symbicort (budesonide and formoterol) would absorb Eklira and Duaklir back. The two types of medicines are under different circumstances. Atacand, under angiotensin receptor blockers (ARBs) class, has an expired patent, but it sold around 25 billion won as outpatient prescription drug last year. AstraZeneca had a joint local sales and distribution deal with GC Pharma since 2011. Eklira and Duaklir’s actual sales figures are not too significant. But retrieving those back would reinforce single-component long-acting muscarinic antagonists (LAMA) and long-acting beta-agonist (LABA) and LAMA combination pipelines at AstraZeneca’s Respiratory Department. The two COPD medicines entered the Korean market as Daewoong Pharmaceutical signed a local sales deal with Spain-based pharmaceutical company, Almirall, in 2004. But AstraZeneca now owns the medicine as it acquired the respiratory pipeline later. Meanwhile, domestic sales contract on Farxiga and a hyperlipidemia treatment, Crestor (rosuvastatin), with Daewoong Pharmaceutical would be maintained as they are.
- Company
- Oral GLP-1 competitiveness depends on price and convenience
- by Nho, Byung Chul Nov 20, 2019 11:50pm
- Although an oral GLP-1 drug, Rybelsus has attracted heightened attention from its market since its recent approval by the U.S. Food and Drug Administration (FDA), it faces some barriers to overcome like inconvenient high-dose regimen and expensive price. Reportedly, once-daily Rybelsus’ effect of glucose control and weight loss is not as effective as once-weekly injection, despite the oral drug’s dosage is hundred times higher than the injection. And also the drug’s price is expected to be higher than other existing oral drugs. Well aware of the concerns, Novo Nordisk (“Novo”) official spoke at a recently held third quarter 2019 earnings presentation and explained that competitors of Rybelsus would not be an once-weekly injection, but other existing oral antidiabetic treatments and Novo’s own once-daily injection, Victoza. Rybelsus is an oral version of Novo’s once-weekly GLP-1 injection, Ozempic, and 7mg and 14mg doses of Rybelsus were approved by FDA in last September for type 2 diabetic patients, who needs to control glucose level with drug as they cannot self-control it by diet or exercise. The biggest risk factor of Rybelsus is in effectiveness. Rybelsus’ glycated hemoglobin reduction rate, which measures treatment effect on diabetic patients, demonstrated similar level of effectiveness as Novo’s own once-daily injection, Victoza. However, the rate was less promising than Novo’s other once-weekly antidiabetic injection Ozempic. According to Novo’s clinical data, taking 14mg of Rybelsus daily for 52 weeks would reduce 1.3 percent of hemoglobin level, whereas 26 weeks of taking 1.8mg of Victoza daily reduces 1.3 percent, and 40 weeks of 1mg of Ozempic weekly reduces 1.8 percent. Treatments in GLP-1 class take a certain period of time to find patient’s adequate dose to minimize the treatment’s well-known adverse reaction, gastrointestinal side effects. For Rybelsus, it takes about eight weeks. Other injectable Saxenda by Novo, Trulicity by Eli Lilly, and efpeglenatide by Sanofi take about four weeks or less. Unlike the Korean market, market expectation on Rybelsus is also lowered by diabetic patients in the U.S. and other European countries not minding so much of pen-type injection device. Clinical trial on single-dose prefilled pen-type injection conducted by Eli Lilly found 99 percent of subject patients completed administration for the target period of four weeks, and 97 percent of them were positive about continuous use of the treatment type. Moreover, Rybelsus’ 14mg high-dose daily regimen is another issue the treatment faces, because such high dosage could lead patient’s pharmaceutical expense to rise. In fact, Rybelsus’ injectable version, Ozempic’s treatment dosage is 1mg per week, but patients taking Rybelsus has to take 98mg (14mg per day) a week of the exact same substance, which is close to a hundredfold of Ozempic. The industry accordingly expects the extensively higher dosage of the drug would inevitably increase patient’s drug expense. “Rybelsus is ‘just another option of oral antidiabetic treatments’ and it is expected to take its unique place in the market. But it has some problems to overcome, compared to an existing once-weekly injection. Rybelsus’ competitors would likely to be other options of oral antidiabetic treatments or once-daily injection like Victoza. Whichever product demonstrates the most outstanding effect, benefit, convenience and safety among once-weekly injections would lead the market, eventually,” a pharmaceutical industry insider commented.
- Opinion
- [Reporter's view] The Korean bio-health industry in Anomie
- by Lee, Jeong-Hwan Nov 20, 2019 11:50pm
- World-class standards of medical technology is Korea's long-standing pride. Advanced bio-new drugs are the future growth fuel that the world pursues, and the Korean pharmaceutical industry is gradually shifting its development focus from generics to new drugs with technology. Expectations and concerns coexist in the public's spotlight toward the medical and biopharmaceutical industries that will affect the future of Korea. It is rare to oppose the achievement of 'high-tech medical and bio-new drugs' that will lower regulatory barriers, speed up the introduction of new technologies, and ultimately directly benefit society and the public. On the other hand, the question of whether to agree to the provision of personal health information necessary for the development of advanced medical and biologic new drugs is not easily nodded in assent. The order to make high-tech medical and new medicine without medical big data is to offer the best dinner without high quality and abundant raw materials. In this respect, The Korean bio-health Industry fell in Anomi. New norms and social values appropriate for advanced medical and biologic drugs and the fourth industrial revolution must be established, but it is the current status of our society that existing traditional norms and values rarely innovate. In other words, the social values, which are essential for the high-level medical care and advanced new drug industrialization, are in a state of confusion and irregularity. Recently, the 4th Industrial Revolutionary Committee urged the government to advance laws and regulations, and to strengthen the capacity for review and licensing. Specifically, the government said that it would reduce social unrest by strengthening public relations about the objective scientific achievements that the biohealth industry would bring along with the revision of the Personal Information Protection Act, medical law, and bioethics law. KIET stated that the Korean bio, IT, and AI industries with excellent technology have fallen into ‘the prisoner's dilemma’, pursuing their own interests among medical world, civil society, and the government. It is a diagnosis that civil society, which has high technology development and government-industrial distrust, is not able to agree on providing sensitive health and medical personal information, and is hindering the development of telemedicine or biomedicine. After all, how to rescue Korea's bio-health industry in an anomalous state is the solution for advanced medical and biomedicine drugs. Citizen anxiety is likely to grow as regulatory innovations take place, and it can create fear that personal information is being used by government or some industries for other purposes. The government should work with expert groups to make concrete plans to break down civil distrust, and quickly resolve the public's lack of cutting-edge bio-information through various public participation external events. Regulatory innovation and industrial development should not be focused on keywords, it made The public, the government, and the industry struggling with each other, and darken the state-of-the-art medical and biopharmaceuticals the future We should be able to explain transparently and specifically how my medical information is used and protected in the development of the biohealth industry and how the individual can finally benefit. Also, it is time to break down chaos and anomie by creating a way for individuals to participate in the biohealth industry.
- Company
- JW Pharmaceutical’s R&D generates fruitful return
- by Chon, Seung-Hyun Nov 20, 2019 06:14pm
- For this year’s third quarter, JW Pharmaceutical recognized total 6.6 billion won made from exporting drug candidate technology. The amount includes upfront fees received from technology transfer deal from last year over atopic dermatitis drug candidate, and from technology export deal on anti-gout drug candidate made last September. The industry evaluates it was fruitful return from R&D investment. JW Pharmaceutical reported on Nov. 19 that the company’s accumulated profit from technology export payment in the third quarter reached 6.6 billion won. The figure reflects upfront payment from two technology transfer deals signed last year and this year. In August last year, JW Pharmaceutical shook hands with Demark-based multinational pharmaceutical company, Leo Pharma agreeing to export atopic dermatitis pipeline, 'JW1601'. Including USD 17 million upfront payment, the deal is worth total 402 million dollars. And in August, the company made a deal with China-based Simcere Pharmaceutical for exporting an anti-gout drug candidate 'URC102'. The deal is worth 70 million dollars, including five-million-dollar upfront payment. But it is quite different as to how these two deals were reflected on the account. The upfront fee on JW1601, 17 million dollars (about 19 billion won), was received September last year. But JW Pharmaceutical decided to recognize 17 billion won at once in August last year, and recognize the rest of 1.3 billion won in 20-month installment from August last year to March next year. So payment of 66.41 million won would be reflected on the account every month until March next year. And up to September this year, payment of about 600 million won (66.41 million won reflected for nine months) was recognized. On the other hand, payment from URC102 deal was recognized all at once. The payment of six billion won was reflected on the third quarter account. However, the actual payment was not transferred in the third quarter. JW Pharmaceutical clarified on the quarterly report that “The payment is to be received in November”. The company, in fact, stated early this month that it has received the payment. A JW Pharmaceutical insider commented, “The payment from the August deal was reflected on the third quarter account as the agreement was finalized then”. Reflecting payments from the two drug candidate technology deals, JW Pharmaceutical has made total of 6.6 billion won profit in the third quarter. The profit from the deals actually helped the company’s overall performance. JW Pharmaceutical generated operating profit of 2.6 billion won in the third quarter, which means it would have made deficit if the technology transfer deal was not reflected. The company may have risked overall earnings with increased R&D expense, but R&D performance is also contributing back to the company’s earnings. JW Pharmaceutical’s earnings were recently worsened due to increased R&D expense. The accumulated R&D expense up to the third quarter was 29.7 billion won, surged by 23.5 percent than the same time year before. The company insider commented, “R&D investment amount was significantly increased recently, as clinical trials for the exported drug candidates have initiated”. The industry sees that the company is well on its way to create a positive cycle of dedicated R&D effort contributing back to the company’s return. Also in last year, JW Pharmaceutical received payment of 4.8 billion won for exporting total parenteral nutrition (TPN) product. JW Holdings signed a licensing-out and export contract with Baxter in July 2013, granting the multinational company rights to supply the TPN product, Winuf to the U.S., Europe and all around the world. The contract is worth total of 35 million dollars, including 25-million-dollar upfront payment and ten-million-dollar milestone payment. With European health regulator giving a green light on Finomel (Winuf’s brand name in Europe), JW Holdings received promised milestone payment of four million dollars last year. The rest of milestone payment, six million dollars is expected to be paid out when the product gets approved in other regions.
