- LOGIN
- MemberShip
- 2026-05-21 00:07:40
- Policy
- Only one case of non-tumor initial human administration test
- by Lee, Tak-Sun Dec 20, 2019 06:35am
- Among the clinical trials conducted by multinational pharmaceutical companies in Korea, the first human-administered trial was found to be very rare. According to the Korea Clinical Trial White Paper No. 2 published by the Korea National Enterprise for Clinical Trials (CEO Dong-Hyun Ji, KoNECT) on the 18th, there was only one initial human dosing study in non-tumor fields conducted by multinational pharmaceutical companies from 2016 to 2018. The initial human administration study mainly examines the pharmacological effects and side effects of the human body in healthy adults and determines the tolerated dose. It will also identify pharmacokinetic properties. Proceeding with the patient will explore the potential for effectiveness. Clinical progress and analysis is known to be difficult because it determines the direction of successful commercialization of the drug. Activation of Phase I clinical trials by multinational pharmaceuticals, such as the first human administration trial, is essential for raising the domestic clinical level. In addition, it means that commercialization of new drug development will be carried out from the beginning, which is related to the activation of new drug development in Korea. In the case of new drugs developed in Korea, Phase I clinical trials are often conducted overseas. Table 63. Characteristics of Phase 1 Clinical Trials in Non-tumor Fields (206-2018) In the first phase clinical trials of the tumor field, the first human trial of multinational pharmaceutical companies was rare. The white paper explained that at least six were approved. During the same period, Korean pharmaceutical companies undertook 28 trials of the first human trial in the non-tumoral field. This is only 7.9% of all phase I nonclinical trials. Even if it was not the first human trial, multinational pharmaceutical companies (including multinational CROs) accounted for only 4.5% of the phase I clinical trials. Tumor field was 23.3%. However, the share of multinational pharmaceutical companies increase as they move to Phase II clinical trials. In Phase II, multinational drug makers accounted for 32.3% of non-tumors and 33.6% of tumors.
- Policy
- Parliament pushes for drug revocation bill w/o sales record
- by Lee, Jeong-Hwan Dec 20, 2019 06:35am
- A bill was proposed by the National Assembly to prohibit the renewal of drug items without sales records. The legislative goal is to minimize damage to Valsartan-Ranitidine impurities (NDMA) by eliminating drugs that some pharmaceutical companies produce only the minimum quantity and do not sell in order to update the product, which is a prerequisite for permit maintenance. On the 18th, Sang-hee Kim, a memeber of the National Assembly's Health and Welfare Commission announced that she proposed a partial amendment to the pharmaceutical affairs law. Current legislation requires the renewal of a drug license and declaration in order to sell the drug after the expiration of the drug product approval and the validity date. Drugs that are not manufactured or imported during the expiration date cannot be renewed Recently, NDMA has been detected in drugs such as high blood pressure treatment, Valsartan and antacid drugs, Ranitidine. It was pointed out that a drug that manufactured and imported only a minimum quantity for the item update and was not actually sold or distributed. Representative Sang-hee Kim pointed out the problem that the drug can be renewed without submitting the data. When renewing a drug product, it is necessary to submit data such as side effects collected during the expiration date, quality control and improvement measures to confirm safety and effectiveness. Drugs that are not actually sold can be renewed without submitting data. In order to protect the public health, it is necessary to check the status of safety and quality control of all medicines when updating drug products. Representative Kim said, “It is the core of the bill to restrict the renewal of product licenses and notifications for drugs that are not manufactured or sold within the validity period, I will build a foundation to provide safe and effective medicines”.
- Company
- Companies done submitting metformin record, what now?
- by Chon, Seung-Hyun Dec 20, 2019 06:32am
- Ministry of Food and Drug Safety (MFDS) Pharmaceutical companies in Korea have completed submitting usage record of metformin medicine to the government body. The industry seems to be patiently waiting for the government’s follow-up action on finding impurity in metformin-containing drugs. According to pharmaceutical industry insiders on Dec. 18, pharmaceutical companies have completed submission of metformin medicine manufacturing status report as requested by Ministry of Food and Drug Safety (MFDS). They compiled data from respective manufacturing plant and sent in the material until Dec. 17. On Dec. 13, MFDS has asked the companies to hand in manufacturing record of drug items containing ‘metformin hydrochloride’ and detailed research result of using the active ingredient by Dec. 17. MFDS requested information on the total number of pharmaceutical products containing metformin, name and number of items with manufacturing record, and name and number of items without manufacturing record. The information should cover all items distributed considering use-by date of complete products. For example, when an items’ use-by date is three years, then the item’s entire manufacturing record after December 2016 should have been submitted. The ministry has also called for a full report on active ingredients used in the metformin products. It is collecting detailed information on DMF registration number and manufacturing plant of a complete product containing the ingredient under each serial number. MFDS preemptively taking a detailed look into the records of active ingredient usage, in case impurity is found. When a specific active pharmaceutical ingredient and complete product is discovered with an issue, the ministry plans to take a prompt and accurate action based on the collected information. Molecular structure of metformin Impurity risk in metformin first started from Singapore. On Dec. 4, Singapore’s Health Sciences Authority (HSA) recalled three items out of 46 metformin containing drugs they investigated. The result confirmed contamination of N-Nitrosodimethylamine (NDMA) has surpassed daily acceptable level. The pharmaceutical industry is anxious that the Korean regulator is “considering on taking follow-up actions like sales ban when the active ingredient is found contaminated”. In fact, before the government body took an action on ranitidine and nizatidine cases, the ministry had reviewed detailed information on complete product and the active ingredients. The ministry held back on the action for ranitidine and nizatidine medicine, until the thorough review on complete products and the ingredients was completed. The ministry may decide to ban sales on metformin medicine, if it confirms the same active ingredient recalled in Singapore has been imported to Korea. In the case of valsartan, MFDS had immediately ordered a sales ban on drugs with the substance when Europe decided to recall the products. Metformin-containing complete products recalled in Singapore have not been imported to Korea, yet. But whether or not the recalled active ingredient has been imported yet has not been confirmed. Reportedly, the Singaporean health regulator decided to recall the products based not on testing result of active pharmaceutical ingredient, but on complete products. However, it is highly unlikely that the Korean regulator would take an action in just a few days as it has not collected samples of metformin ingredients and complete products for testing. Both for ranitidine and nizatidine medicine, the regulator announced the follow-up measure after collecting samples of ingredients and complete products from different manufacturing dates, along with a thorough review on usage record. Ironically, the ministry has not presented an official procedure of NDMA testing for metformin, yet. MFDS is currently working on NDMA testing for metformin, which is scheduled to be completed by the end of the year. When the official testing procedure is set, the ministry is to collect the active ingredient and complete products for testing.
- Policy
- Swiss companies to benefit from mutual recognition of GMP
- by Lee, Tak-Sun Dec 19, 2019 11:20pm
- A mutual recognition agreement of Good Manufacturing Practice (GMP) with Swiss pharmaceutical regulator Swissmedic would not only invigorate pharmaceutical trade between two countries, but also it is expected to be a meaningful step towards Korea earning recognition of international level of regulation. The mutual GMP recognition agreement would bring significant influence on Korea, as Switzerland is one of A7 countries, which the Korean regulators refer to when deciding new drug pricing, and is also a pharmaceutical powerhouse with headquarters of Novartis, Roche and other major global companies. Korea’s Ministry of Food and Drug Safety (MFDS) announced on Dec. 18, it would be officially signing a Mutual Recognition Agreement (MRA) of GMP with Swissmedic. When the agreement comes in effect, GMP evaluation when applying for new drug approval in either country would be exempted. GMP certificate from either country would be validated in the other country. As a result, local due diligence, written review and other review procedures would be eliminated and ultimately accelerate the drug approval process. Korean pharmaceutical and bio companies would be able to reduce commercialization preparation period in Switzerland with the mutually recognized GMP certificate. The same goes for Swiss pharmaceutical and bio companies. Their new drug would be exempted from MFDS’ GMP evaluation. Actually, Korea has more drugs importing from Switzerland than exporting to them. Pharmaceutical powerhouse Switzerland houses major global pharmaceutical companies like Novartis and Roche. To this date, MFDS reviewers paid a visit to the local manufacturing plant and conducted GMP due diligence when reviewing Swiss pharmaceutical products. The MRA would drop GMP due diligence and other written review, which would reduce Swiss drug’s approval period in Korea by three to four months. It would be remarkable benefit for Novartis, Roche and other Swiss pharmaceutical companies. Targeting the Korean market, the Swiss companies now have the upper hand against other U.S. or European pharmaceutical companies. Although Korea exports less volume of pharmaceutical products to Switzerland, the intangible value generated from the MRA would shine through for the Korean industry later in the future. Signing of the MRA could mean that such a major pharmaceutical powerhouse recognizes Korea’s regulatory capability. The GMP recognition agreement MFDS signed with Ecuador in 2014 only applies to Korean drugs applying for approval in Ecuador, and it does not apply on Ecuadorian drug in Korea. MRA can only be signed by two countries when their regulatory standards are mutually recognized as equivalent level. Accordingly the signing of the MRA proves Switzerland also thinks highly of Korean regulatory standards. This could be favorable for Korea when negotiating with other countries. MFDS is currently seeking for opportunities to negotiate MRA on GMP with countries that have joined Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme (PIC/s). Increasing number of countries with high faith in Korean regulatory system would simplify local new drug approval process for Korean-made drugs and also positively influence the industry’s business. MFDS official explained, “As Switzerland is not part of EU, it had an independent regulation apart from EMA and Korean companies had to go through another set of review process. The country is a home of global companies like Roche and Novartis, and CMO companies like Lonza. Korea has been recognizing Switzerland as one of A7 external reference pricing countries with their outstanding review capability that other advanced countries also approve of”. “MRA with Switzerland on GMP would be an opportunity for Korea to raise awareness of Korea’s trustworthy regulatory capability to other countries”, the official added.
- Company
- Anti-ulcer market fluctuates from impurity risk aftermath
- by Chon, Seung-Hyun Dec 19, 2019 06:41am
- Apparently, the anti-ulcer treatment market is still shaken with the impurity contamination risk. The market volume of nizatidine drugs, with a recent discovery of impurity exceeding an acceptable level, subsided within a month. A several cases of impurity found in products brought down the H2 receptor antagonist prescription volume, but rather pushed up the proton-pump inhibitors (PPI) prescription volume. Among PPI class drugs, esomeprazole has been the strongest in the market. On Dec. 18, pharmaceutical industry research firm UBIST reported the outpatient prescription volume of H2 receptor antagonist last month marked 9.3 billion won with a 5.6-percent decrease from the month before. Immediately after the sales ban on ranitidine, the prescription volume of the medicine has plunged to 40 percent level and the descending trend line continued to last month. Monthly trend of outpatient prescription volume of H2 receptor antagonist-containing drugs (unit: KRW 1 million) Source: UBIST Monthly trend of outpatient prescription volume of H2 receptor antagonist-containing drugs, except ranitidine drugs (unit: KRW 1 million) Source: UBIST Ruling out ranitidine, the H2 receptor antagonist market showed inconsistent prescription volume. The H2 receptor antagonist prescription volume, except ranitidine, skyrocketed from 6.4 billion won in September to 9.8 billion won in October by 53.5 percent. As most of ranitidine prescriptions were switched to other H2 receptor antagonist substance, the general market volume also expanded. But the H2 receptor antagonist prescription volume went down only in a month. Specifically, the nizatidine drugs took a noticeable fall. Monthly trend of outpatient prescription volume of major H2 receptor antagonist substance (unit: KRW 1 million) Source: UBIST In last month, nizatidine drug prescription volume fell by 30.5 percent from the previous month and generated 2.3 billion won. When ranitidine drugs were banned, nizatidine drugs’ perception soared by 42.5 percent from September to October. But merely in a month, the volume went back down to the September volume. The fall was affected by the discovery of impurity in some of the items. On Nov. 22, Ministry of Food and Drug Safety (MFDS) found unacceptable level of cancer-causing N-nitrosodimethylamine (NDMA) in nizatidine-containing drugs, and banned sales on 13 items. Unlike ranitidine, only some of nizatidine drugs were banned. Doctors could choose other nizatidine-containing items other than the banned ones, but they started prescribing other options due to unsettling risk of the substance. Benefitting from the sales ban on ranitidine and nizatidine drugs, famotidine and lafutidine drug prescription volumes reached their highest peak. Famotidine prescription volume doubled in October from the previous month, and was increased by 10.6 percent from October to November as well. Whereas lafutidine prescription volume reached 2.6 billion won, increased by 13.3 percent from the previous month and reached its peak. Cimetidine’s prescription volume was at 1.1 billion won last month and took a slight fall. Insufficient supply of active ingredient depleted stock and was excluded the drugs from the impurity risk benefit. Drugs in PPI class maintained a positive trend line last month as well. Last month, PPI-class treatments had outpatient prescription volume of 42.2 billion won with an increase of 1.0 percent from the previous year and recorded the highest volume of the year. In September, the volume reached 37.3 billion won and had a 17.7-percent surge in a month. Monthly trend of outpatient prescription volume of PPI-containing drugs (unit: KRW 1 million) Source: UBIST Meanwhile, esomeprazole-containing drugs had the steepest growth. Last year, the drug’s outpatient prescription volume grew by 5.0 percent in a month and reached 17.7 billion won. After making an increase of 21.3 percent from September to October, the drug’s prescription volume was expanded even more. Esomeprazole prescription volume last month soared by 27.4 percent from September. As of November, esomeprazole dominated 40.0 percent of the PPI medicine market. It could be interpreted that the doctors have switched from ranitidine and nizatidine to esomeprazole as they prefer the medicine the most within the PPI class. Rabeprazole’s prescription volume in last month went up by 1.2 percent from the month before, but lansoprazole, pantoprazole, ilaprazole and omeprazole’s prescription volume in November were dropped by a little than in October. But in general, the said PPI-class medicines had more than a ten-percent surge from September, benefitting from the impurity contamination risk. Monthly trend of outpatient prescription volume of major PPI substances (unit: KRW 1 million) Source: UBIST
- Policy
- Mandatory evaluation of MFDS when using all off label drugs
- by Lee, Jeong-Hwan Dec 19, 2019 06:35am
- A bill is piloted to require government assessments when using 'off-labeled drugs' in patients that go beyond the indications that have been proven in clinical trials, which are phases of drug marketing. Representative Sang-hee Kim of the National Assembly on Health and Welfare on the 18th proposed the partial revision of the Pharmaceutical laws and regulations. Off-labeled use of current drugs differs from individual use procedures, such as those subject to reimbursed benefits and non-reimbursed, over-the-counter and anticancer drugs. Representative Sang-hee Kim said that the pharmaceutical industry is passive in research and development of medicines that meet the medical needs such as rare and severe diseases, children, and pregnant women, and encourages the use of off-label. It is pointed out that the use of off-labeled drugs with different efficacy, effect, indications, and dosage is not frequently recognized by the Ministry of Food and Drug Safety, which is a drug approval authority. Representative Kim criticized that MFDS conducts off-label use evaluation only for non-reimbursed generic drugs according to the Ministry of Health and Welfare, so systematic safety management of over-licensed drugs is not possible. Representative Kim said, “To prevent this, we need to establish a legal basis for the safety and effectiveness evaluation of MFDS for all use of off-label drugs, we will promote public safety by establishing a systematic evaluation environment for non-permission use”.
- Company
- Punishment for rebate MD is on the rise
- by Jung, Hye-Jin Dec 19, 2019 06:35am
- A series of tougher penalties rulings against the medical personnel's illegal rebates have been issued. Once caught, the ruling to collect the full rebate collection has become the trend. Analysts say that the justice department increase the level of rebate punishment. Dailypharm's analysis of the major rulings on drug rebates on the 17th showed that in four recent cases, medical personnels were charged with the amount of rebates they received from pharmaceutical companies in addition to imprisonment or fines. Dr. A, who runs a hospital in Paju, Gyeonggi-do, was charged with receiving ₩15 million for prescribing medicines from a pharmaceutical company and was sentenced to a fine of ₩3 million by the Suwon District Court in September. The court ordered Dr. A to collect ₩100 million in addition to the fine. In October, similar rulings were followed in Suwon and Daegu. The Suwon District Court Seongnam branch decided on a year of imprisonment and a ₩150 million penalty for Dr. B, who operates an ophthalmologist in Ulsan. The additional ₩150 million is the rebate that Mr. B received twice from a pharmaceutical company. The Daegu District Court sentenced doctor C, who received a rebate, to pay a fine of ₩2 million and a penalty of ₩2.65 million. The penalty is also equal to the amount of rebate that Mr. C received from the related pharmaceuticals. Unlike other doctors, Dr. B was sentenced to one year in jail because he demanded more rebates from pharmaceutical companies on the condition that he would increase the size of the existing hospital and increase the volume of drug transactions. The court found that Mr. B was aggressively trying to get a rebate, and gave him to a severe sentence. In November, the Suwon District Court decided to pay a fine of ₩4 million by applying to Dr. D for violating medical law. Dr. D was not accompanied by a punishment, but the ruling said that “It is necessary, but it is clear that it did not collect from an abbreviated order, so the addition of collections in addition to previously sentenced sentences is not permitted in the interpretation of section 457, paragraph 2 of the Criminal Procedure Act”. the court revealed the reason for not being sentenced. In addition, the Seoul Central District Court ruling, which was made earlier, also shows a trend of strengthening the penalty. In June, the court sentenced Doctor E, who violated the Medical Law, two years probation for one year in prison and two years probation for eight months in jail for a representative of a wholesaler who violated pharmaceutical laws that provided rebates. Four of the five rebate-like judgments were received 100% collection. The other one, which did not order the collection, also revealed a valid basis for which the criminal law does not allow for collection. Article 88 (2) of the current Medical Law allows the collection of medical personnels who have received illegal rebates. Such trends in local jurisdictions show recent trends in penalties for drug rebates. Previously, even if rebates were caught, fines, probation, and imprisonment were mostly imposed, but as the recent rulings show, the government is collecting 100% of the rebates illegally received by medical personnel. The lawyer Jong-sik Woo of the law firm Gyuwon also made the same opinion that “Is it because of the light punishment that the judges are not eradicating the rebate?” Attorney Woo said, “A recent analysis shows that there is a clear trend to strengthen the penalty, recently the ruling on illegal rebates shows that the frequency of collecting 100% of the money received is almost the same”. “The legal basis for the surcharge was from the stage of a dual punishment system. The law was not changed, but the court is raising the surcharge level recently”. “It is analyzed that the Tribunal is moving towards the strengthening of collections to eradicate drug rebates.” he added.
- Policy
- First Samsca generic submits approval application
- by Lee, Tak-Sun Dec 19, 2019 06:34am
- 오츠카 The first generic to follow Korea Otsuka Pharmaceutical’s Samsca (tolvaptan), indicated for treating euvolemic hyponatremia, has submitted an approval application to Korean Ministry of Food and Drug Safety (MFDS). The industry believes Myung In Pharma would be the one to grab the approval as it has been challenging the patent and developing the follow-on drug. According to MFDS on Dec. 17, a tolvaptan-containing drug submitted an application for approval. The drug in 15 mg dose is administered once-daily to treat patients with hyponatremia. As stated by the Drug Approval-Patent Linkage system, MFDS notified Otsuka, the patentee, about the submitted application. Otsuka’s Samsca is protected by a patent on solid preparation and its manufacturing method of the medicine including bezoazepine, which is to be expired on June 20, 2028. In last May, Myung In Pharma evaded infringement of Samsca’s drug patent with Intellectual Property Trial and Appeal Board’s ruling. The company filed a defensive confirmation trial for the scope of a right, which then was affirmed. And in the same month, the company’s bioequivalence test protocol was cleared. Based on the clues, the industry is convinced Myung In Pharma has probably applied for the approval. The original Samsca is the first-and-only hyponatremia treatment approved by MFDS in September 2011. Hyponatremia is an electrolyte-associated adverse event commonly found in hospitalized patient, which can cause serious neurologic complications. Before Samsca was available, intravenous fluid with high concentration of sodium was given to the patients, but it did not treat the cause. Recently, Samsca was granted with reimbursement approval on indication for treating patients with Autosomal Dominant Polycystic Kidney Disease (ADPKD). If Myung In Pharma snatches the first generic title in the market, it is expected to earn a significant commercial success with minimum competitors.
- Company
- New flu season to spark up another round of competition
- by Kim, Jin-Gu Dec 18, 2019 02:25pm
- KCDC public service announcement about preventing influenza by getting flu shot, properly washing hands, covering mouth when coughing and visiting healthcare institute when feeling unwell The flu season in Korea has just arrived for the year. Korea Centers for Disease Control and Prevention (KCDC) issued a flu warning on November 15. The season is to last until May next year. The new flu season is to start up even more fierce competition in the flu treatment market. The market leader, Tamiflu (oseltamivir) sales has been tumbling down since oseltamivir generics were launched. What’s worse, the flu treatment’s adverse reaction risk reported last season had its market position precarious. Now the gap between Tamiflu and the runner-up Hanmi Flu is in arm’s length. Prescription volumes of generics, on the other hand, are neck-and-neck, while the original’s performance is stagnating. Moreover, intravenously administered Permiflu jumped in to the already-heated competition strong with convenience of single-dosage. Now with the new flu season just penning, let us round up the highlights of the flu treatment market. ◆Tamiflu adverse reaction risk from last year, so what’s next this year? Last winter, Tamiflu was struck down with a concerning issue. In December last year, a middle school student fell from an apartment and was found dead in Busan, after taking Tamiflu. The student’s family suspected adverse reaction as she complained of hallucination after taking Tamiflu. And the media highlighted sporadic reporting of suicidal reaction from Tamiflu in Japan. The risk did not subside easily. As a result, the original and oseltamivir generics together generated prescription volume of 24.7 billion won in last flu season from November 2018 to May 2019. Compared to the 2017-2018 season generating 31.1 billion won, the last season’s sales dropped more than 20 percent. Besides, it was a big loss for the drugs considering the flu season struck hard last year. According to Health Insurance Review and Assessment Service (HIRA), 4.74 million patients visited hospitals for flu in the 2018-2019 season. The figure was at four-year high and it was 5.5 times more than 860,000 patients in the 2014-2015 season and 2.1 times more than 2.29 million patients in the 2017-2018 season. Tamiflu and generic prescription volume (source: UBIST) and flu patient size from last five season (source: HIRA) While the overall oseltamivir products had a drop in prescription volume, the original Tamiflu took the biggest blow. Its prescription volume plunged from 12.2 billion won to 7.7 billion won in a year. Hanmi Flu generating the second highest sales narrowed the gap with Tamiflu from 3.8 billion won to 1.7 billion won in the same period. The industry predicts the generic could actually surpass the original this season according to the trend. Top two market leaders Tamiflu and Hanmi Flu’s prescription volume in last five seasons (Unit: KRW 100 million) Source: UBIST ◆Peramiflu almost triples market share As a result of Tamiflu’s adverse reaction risk, GC Pharmaceutical’s Peramiflu (peramivir) took the opportunity. Compared to the previous season, the peramivir medicine’s market share more than doubled last season. The National Assembly Health and Welfare Committee reported 67,518 patients were prescribed with Peramiflu as of December last year. It was 4.4 times more than 15,481 patients in the season before. In the general flu treatment market including Tamiflu, Peramiflu’s share soared from 2.0 percent to 5.4 percent, about 2.7 times the rate. Some hospitals and clinics struggled to get a hold of Peramiflu stock, because a sudden spike in sales exceeded projected demand,. Apparently, pediatric institutes especially had difficulty in acquiring needed supply. Peramiflu also won expanded indication on pediatric patient under the age of two. And some sees that the word of mouth from young patients’ parents, concerned of the recent Tamiflu risk, have affected the shortage. ◆Hanmi Flu gulping up generic market share Since Roche introduced Tamiflu to Korea in 2000, its market share grew significantly in 2009 with the new influenza sweeping the nation. And the treatment dominated the market in the 2014-2015 season. In the 2015-2016, Hanmi Pharmaceutical modified the original’s saline substance to avoid patent infringement and launched Hanmi Flu. The incrementally modified drug generated 1.5 billion won from the first season’s prescription and had a perfect soft landing on to the flu treatment market. The prescription sales also hiked exponentially in the 2016-2017 season at 8.3 billion won. From the 2017-2018 season, Tamiflu’s patent was expired and generics flooded out to the market. About 50 pharmaceutical companies entered the oseltamivir generic market. The generics made a huge success from their first year. 31.1 billion won worth of generics were prescribed in their first flu season from 2017 to 2018. Tamiflu and oseltamivir generics’ prescription volume in 2018-2019 season (Source: UBIST) However, their sales plummeted to 24.7 billion won with the Tamiflu risk in the 2018-2019 season. But the upside was that the market share of generics in the overall flu treatment market surged from 60.9 percent to 68.8 percent. The generic’s share is expected to surpass 70 percent this season. Interestingly, the number one generic Hanmi Flu’s prescription volume has dropped from 8.4 billion won in 2017-2018 season with share of 26.9 percent to 6.0 billion won in 2018-2019 season with 24.3 percent market share. The decrease in Hanmi Flu’s market share was actually shared among other generic items including Fluone (Jeil Pharm), Seltaflu (Inist Bio), Tami-infle (Hutecs), Boryung Tami (Boryung Pharmaceutical), Tamipro (Arlico Pharm), Bisel Flu (Wooridul Pharmaceutical), Dongwha Flu N (Dongwha Pharm) and Tamiforce (Ilsung Pharmaceuticals). All of the said generics had growth in sales and market share. Meanwhile, Roche Korea is aiming for a turnaround with a new launch of Xofluza. However, the company would be unlikely to recover the fall this season as the new flu treatment launch would take a place in March next year at earliest.
- Company
- ‘Noltec’, domestic new drug sets a new record
- by Chon, Seung-Hyun Dec 18, 2019 06:25am
- Il Yang's anti-ulcer drug 'Noltec' is breaking a record every day. Continued upward trend after expanding indications, the company benefited from the reflection of impurities from competing drugs. According to UBIST, a drug research agency on the 17th, Noltech's outpatient prescriptions last month increased by 16.7% to ₩2.9 billion. By November, the cumulative prescription amount for this year was ₩28.2 billion, up 20.1% from last year's ₩23.5 billion. Noltec, released as a new domestic drug at the end of 2009, is a proton pump suppression (PPI) drug developed by Il Yang Pharmaceutical. Noltec's recent upswing is fueled by increased indications and the exit of competitive products. Initially, Nortec was licensed to treat only 'gastric ulcer' and 'duodenal ulcer'. But at the beginning of the launch, it did not stand out in the market. The reason for this is that they did not have indications for reflux esophagitis, which account for about 80% of the PPI drug market. Nortec's sales have risen vertically since winning the indication for reflux esophagitis in 2012. In 2014, the prescription amount exceeded ₩10 billion, and since then, H. pylori bactericidal indications have been added, showing rapid growth, and recorded prescription amount of ₩26.2 billion last year. Recently, the suspension of Ranitidine have been worked favorable factor. In September, the government suspended a sale of all anti-ulcer ranitidine products. In fact, it decided to exit the market because of its excess of carcinogen N-nitrosodimethylamine (NDMA). The discontinuation of ranitidine led to a significant increase in the use of H2 receptor antagonists and PPI-based drugs with similar treatment areas, and Noletec benefited. Recently, some of the Nizatidine-based products have been discontinued due to NDMA detection, and PPI-based drugs are becoming more popular. Nortec's prescription exceeded ₩3 billon for the first time in October, just after Ranitidine was discontinued. It increased 23.2% YoY and rose 20.1% MoM. Since the Ranitidine’s suspension of sale, prescriptions for October and November totaled ₩6 billion, up 20.3% YoY. If this is the case, Nortec is likely to surpass ₩30 billion in prescriptions for the first time since its launch.
