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- 2026-05-11 12:54:01
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- Quadrivalent Flu Vaccine for NIP, failed in bidding
- by Aug 13, 2020 06:25am
- The procurement of a tetravalent vaccine for influenza for NIP failed bidding three times due to an excessively low unit price. According to related industries on the 10th, two bids for the '2020-2021 season influenza vaccine purchase' conducted by the KCDC were failed on the 28th of last month. Initially, New Medipharm and PharmWorld (NIP, local government project, AI response, etc.) and Seojun Pharm (children, pregnant women) were each successful bidder, but both failed to submit a supply confirmation and gave up delivery. The government's low unit price setting is blamed as the reason for abandoning delivery. The government set the estimated unit price for a quadrivalent flu vaccine at ₩8,790. This is only 60% of the usual supply price of ₩14,000 to ₩15,000 for tetravalent vaccines. Even this is also somewhat increased due to the failure in bidding. At the time of the first bidding on the 2nd of last month, the estimated unit price suggested by the KCDC is ₩8,490. Wholesalers who did not receive a supply agreement from the manufacturer at an excessively low price eventually gave up supply. Accordingly, the government slightly increased the unit price to ₩8,610, but it was sold as a single bid. In the third bid, ₩8,790 was offered, but the final successful bid was not achieved. It is in danger of delaying the government's plan to complete the contract in July and begin purchasing in August with subsequent reservations to begin full-fledged vaccination from October. The government plans to conduct an urgent bid to purchase an influenza vaccine on the 13th, but the possibility of failing in bidding remains as it is applying the same unit price as the last bid. An official from the flu vaccine manufacturing industry said, "The government’s proposed tetravalent vaccine supply price is almost no difference compared to the trivalent vaccine price, which has a low production cost." Also, as the NIP supply price decreases, the difference between the supply price in the private market widens, which is a burden for manufacturers. This is because the greater the gap, the stronger the demand for price cuts in the private market will increase.
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- Big 5 pass Qsymia powered by Alvogen-CKD co-marketing
- by Eo, Yun-Ho Aug 12, 2020 06:00am
- The Big Five general hospitals have cleared the prescription of Qsymia speedily widening its brand awareness within the obesity treatment market. According to pharmaceutical industry sources, the drug committees at Big Five hospitals like Seoul National University Hospital, Severance Hospital, Samsung Seoul Medical Center and Seoul Asan Medical Center have reviewed and approved the prescription of Qsymia supplied by Alvogen and its Korean co-marketing partner Chong Kun Dang. Seoul St. Mary's Hospital is also in the process of reviewing the drug. The prescription code has been landed in Korea University Anam Hospital, Ajou University Hospital and other major hospitals around the country. Qsymia can be prescribed in four different doses—3.75 mg/ 23 mg, 7.5 mg/ 46 mg, 11.25 mg/ 69 mg and 15 mg/ 92 mg—and their pricing have been fixed to 4,000 won per tablet. Belviq, Contrave and Qsymia’s cost per day are about the same in Korea and the U.S. A clinical study on Qsymia found the drug demonstrates the most superior effect in weight loss among the Food and Drug Administration (FDA)-approved long-term obesity treatments, and shows better safety than Saxenda or Contrave. The retrospective meta-analysis study comparing five drugs have reviewed 28 randomized clinical studies on 29,018 patients. Qsymia showed the best weight loss effect in losing over five percent of body weight, and Saxenda, Contrave, Belviq and Xenical followed in the order. The distribution of the drug effect in patients who have lost over 10 percent was also led by Qsymia (54 percent) and followed Saxenda (34 percent), Contrave (30 percent), Belviq (25 percent) and Xenical (20 percent). Saxenda and Contrave had the highest risk of halting the administration due to adverse reaction, whereas Belviq had the lowest. Qsymia’s level of risk was around the mid-way between Saxenda and Belviq. In just three months after the release, Qsymia generated 4.3 billion won in a quarter and seconded the obesity treatment market in Korea. The sales gap between Qsymia and Saxenda are only 1.6 billion won. The drug has already doubled the sales of Daewoong Pharmaceutical’s Dietamin, which has been tailgating after Saxenda until the fourth quarter last year. Qsymia is a phentermine plus topiramate combination drug developed by the U.S.-based Vivus, and Alvogen signed a deal in 2017 to supply the drug to Korea. Alvogen then inked a co-marketing deal with Chong Kun Dang in last year, and fully initiated the sales and marketing activities from early this year. Alvogen, with experience in obesity treatment sales like Furing and Furimin, have generated a synergy effect with Chong Kun Dang’s sales power for the obesity treatment to quickly take up the market. A pharmaceutical market research firm UBIST found Qsymia has made 310 million won and 614 million won in last January and February, respectively, and placed itself on the leader board following Saxenda (875 million won), Dietamin (847 million won) and Hutermin (780 million won) as of February.
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- Sayana and Gonal-F shortage may last longer than expected
- by Aug 12, 2020 05:59am
- Shortages in various drug products are reportedly caused by manufacturing facility changes and unstable supply of pharmaceutical substances. According to pharmaceutical distribution industry sources on Aug. 10, Pfizer Pharmaceutical Korea, Merck Korea, Dalim Biotech and other companies have recently informed of shortages in some products. Pfizer Pharmaceutical Korea notified of halting supply of an injected female contraception Sayana (104 mg/ 0.65 mL) from coming October. The subcutaneous injection is currently indicated for contraception or pain from endometriosis in female patients. The global company explained the unstable production delay in the manufacturing facility would prolong the shortage. The final batches of supply are to be expired on May 31, 2023. Merck Korea’s self-injected fertility treatment Gonal-F Pen (300/ 450/ 900 IU) would also experience temporary shortage due to delay in supply. Apparently, the QC schedule in Korea was postponed. Merck Korea stated, “The supply would be ceased around Aug. 10,” but “It would resume around second or third week of September. And more accurate schedule would be notified again in late August or early September.” The importation schedule for Menarini Korea’s diuretic Torem 2.5 mg tablet has been pushed, because the company is changing the overseas manufacturing facility. The supply is expected to resume from Sept. 4. Regardless, Torem 5 mg or 10 mg tablets would be supplied normally. Dalim Biotech issued a notice on temporary shortage in Norpin 20 mL injection due to reevaluation on the transferred manufacturing facility. Dalim Biotech official noted, “As the company moved its manufacturing factory, the health authority has also been changed from Gyeongin Regional Office of Food and Drug Safety to Seoul Regional Office of Food and Drug Safety. And the health authority requested reevaluation on Norpin,” accordingly, “The product would likely to experience temporary shortage until the Ministry of Food and Drug Safety (MFDS) completes the evaluation.” The shortage is expected to last about a month, and the normalized supply would resume from late August to early September. With the manufacturing factory transfer, Dalim Biotech is also having a temporary shortage in a diabetic nephropathy treatment Lipo-A tablet 30T. However, Lipo-A tablet 500T is in supply. Meanwhile, Ildong Pharmaceutical’s OTC digestive Soxinase Triple tablet 300T and Korea United Pharm’s hypertriglyceridemia treatment Omethyl QTlet 2 g soft capsule are also out of stock at the moment as the companies are dealing with problems in substance supply. Currently, the two companies do not have specific dates for the resumption of the product supply.
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- Appropriate use of NOAC in patient with major bleeding risk
- by Eo, Yun-Ho Aug 10, 2020 06:02am
- Images of NOAC products released in Korean market As the prescription cases of new oral anti-coagulant (NOAC) have been accumulating, the prescribers are paying a closer attention on adequately prescribing for patients with high risk of bleeding. HAS-BLED score, the most well known scoring system for measuring major bleeding risk, indicates patients scoring over three are equivalent to tripling the major bleeding risk of patients scoring zero to one. Especially because the ratio of patients with atrial fibrillation scoring HAS-BLED over three has been rising constantly, the bleeding control during an anti-coagulant treatment became a significant factor. Data on patients with atrial fibrillation in Korea shows the ratio of elderly patients aged over 80 is noticeably growing. And the risk of major bleeding has heightened even more as the ratio of patients with other underlying diseases like hypertension, diabetes and heart failure is increasing sharply. A study found patients who scored over three in HAS-BLED took approximately 40 percent of total patients who have been diagnosed with atrial fibrillation in 2006, but the figure rose up to 60 percent in 2015. The average score also climbed from 2.07 in 2006 to 2.75 in 2015. Considering various factors, atrial fibrillation patient with high risk of bleeding has to use controlled dose of NOAC according to the guideline. Patients showing creatinine clearance (CrCl) of less than 50 mL/ min would be prescribed with Xarelto (rivaroxaban) 15 mg (low-dose). And Eliquis (apixaban) and Lixiana (edoxaban) would be prescribed in 2.5 mg and 30 mg doses, respectively, depending on body weight and age as well as the patients’ renal function. Professor Kim Namho of internal medicine department at Wonkwang University Hospital commented, “An elderly female patient aged about 80 and underweight at around 40 kg would be considered high risk when treating anti-coagulation. But a patient manifesting CrCl of over 50 mL/ min or at the borderline, prescribing the indicated dose may not be advisable. And cases of using low-dose NOAC have been reported in one out of two atrial fibrillation patients.” The professor added, “If the dose control is inevitably needed for the patients’ condition, basing it on evidences collected so far would be crucial. As real world data on Korean patients have been accumulated, the prescribers should refer to the evidences accordingly when prescribing the right drug in right dose.” Meanwhile, the renal function may start to fail irreversibly depending on the age or heart function of the patient. As the renal function heavily affects bleeding, the next issue to be addressed and explored would be which NOAC to use in atrial fibrillation patient with expected failure or already low renal function.
- Company
- Hanmi, promotes COVID-19 tx, Ambroxol HCl Sln for Inhalation
- by Aug 10, 2020 06:00am
- Beijing Hanmi’s Ambroxol HCl Solution for Inhalation Hanmi's Chinese subsidiary, Beijing Hanmi Pharmaceutical, announced on the 6th that it will develop a secretolytic agent, 'Ambroxol HCl Solution for Inhalation' as COVID-19 treatment. Earlier, top expert consensus in Chinese pediatrics and two organizations at the drug management control center in Guangdong Province, China, commented on 'Ambroxol HCl Solution for Inhalation' as a recommended drug for COVID-19. In China, prognosis that significantly lowers the risk of hypoxia death due to 'acute respiratory disorder symptom (ARDS)' and 'cytokine release syndrome (CRS)', an overactive immune response, has been reported in patients with COVID-19 who received 'Ambroxol HCl Solution for Inhalation' for the purpose of treating expectorant. 'Ambroxol HCl Solution for Inhalation' is a treatment for a secretolytic agent in the form of a vaporizer that is inhaled by mouth. Since its first commercialization in Germany in 1979, it is based on 'Ambroxol', which is widely used around the world. Alveolar Type II Cells secrete surfactants so that expectorants do not stick to the alveoli and are easily discharged. It was approved in July of last year in China. Hanmi plans to promote a clinical trial that uses the expectorant in combination with COVID-19 treatment. Starting with Hyeophwa Hospital affiliated with Wuhan University of Science and Technology, which is a 5,000-bed high-level university hospital in Wuhan, China, a full-scale clinical discussion has begun with Beijing Ditan Hospital and Shanghai Public Health Clinical Center. Hanmi is in the process of obtaining approval for this expectorant in the US, Europe, and Korea. An official of Hanmi said, "This expectorant's clinical trial will be linked to the 'Hanmi Covid MDT Program', an innovative integrated treatment regimen of Hanmi that covers the entire COVID-19 treatment."
- Company
- AZ, Takeda and Pfizer to compete in PARP inhibitor market
- by Eo, Yun-Ho Aug 07, 2020 06:28am
- The competition ground among poly ADP ribose polymerase (PARP) inhibitors targeting BRCA gene has widened as Pfizer entered the South Korean market following the footsteps of AstraZeneca and Takeda Pharmaceutical. According to the pharmaceutical industry sources, the Korean health authority approved of Pfizer Korea’s Talzenna (talazoparib), indicated to treat patients with germline BRCA (gBRCA)-mutated breast cancer, on July 30. Unlike AstraZeneca’s Lynparza (olaparib) and Takeda Pharmaceutical’s Zejula (niraparib) with initial indication for treating ovarian cancer, Talzenna started off with the indication for treating breast cancer. Talzenna was approved as a single therapy to treat patients with gBRCA-mutated human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer. A PARP inhibitor, Talzenna suppresses PARP1 and PARP2 genes that produce proteins involved in DNA repair. As a result, the medicine hinders the DNA repair in gBRCA-mutated cancer cell and induces cancer cell death. The latest approval was based on Phase III, open-label, randomized EMBRACA trial outcome that tested Talzenna against healthcare provider’s choice of chemotherapy in 431 patients with a gBRCA mutated and locally advanced or metastatic HER2- breast cancer, who may have received up to three prior chemotherapies. The primary endpoint of EMBRACA trial evaluated median progression-free survival in Talzenna-only group (8.6 months) against chemotherapy group (5.6 months), and confirmed significant improvement made by Talzenna. The study also found the drug reduced the risk of disease progress or death by 46 percent more than the chemotherapy. The key subgroup analysis among patients with triple-negative breast cancer, hormone receptor positive, and relapsed metastasis in central nervous system also confirmed the benefit of improving PFS. For the second endpoint objective response rate (ORR), the Talzenna group demonstrated 62.6 percent and doubled the chemotherapy group’s ORR at 27.2 percent. Meanwhile, the two other PARP inhibitors in the market are already hectic preparing for the indication and healthcare coverage expansion. Lynparza took the pharmacoeconomic evaluation-exemption route and settled on the expenditure cap type risk sharing agreement (RSA) in October 2017. It was initially listed for maintenance therapy in patients with ovarian cancer after chemotherapy, but it is now in progress of expanding healthcare coverage on indications—first-line maintenance therapy in patients with BRCA mutated metastatic ovarian cancer, single maintenance therapy in patients with platinum-sensitive recurrent high-grade epithelial ovarian cancer, and in patients with HER2- metastatic breast cancer. In late last year, Zejula was also listed as a maintenance therapy in patients with ovarian cancer who have received chemotherapy. Now the drug is seeking for reimbursement expansion as a maintenance treatment in gBRCA mutation-negative patients with recurrent epithelial ovarian cancer, who are in a complete or partial response to platinum-based chemotherapy, and also as a single therapy treating patients with relapsed ovarian cancer, who have received more than four chemotherapies. However, the Cancer Deliberation Committee, the starting point of the coverage expansions, has been skeptical about Lynparza in mBRCA and Zejula in gBRCA-negative indications and denied the expansion.
- Company
- A big deal after various exchanges between companies
- by Lee, Seok-Jun Aug 07, 2020 06:27am
- Big Deal (License Out/LO) of the traditional pharmaceutical companies show that there have been various exchanges in the past. Looking at the recently established Hanmi and Yuhan’s technology transfer partners, it was because there were exchanges such as joint promotion in the past. It was that exchanges in the past led to exchanges between research institutes of both companies, and even technology transfer. Hanmi transferred NASH (non-alcoholic steatohepatitis) treatment, Efinopegdutide (HM12525A) to MSD USA at a scale of ₩1 trillion (down payment of ₩12 billion). It is an analysis that both companies' past ties were involved in the technology export contract. The relationship between Hanmi and MSD goes back to 2009. At the time, the two companies signed a contract to export the hypertensive treatment drug Amosartan to over 50 countries under the brand 'Cozaar XQ'. In 2016, the two companies signed Rosuzet's global export contracts in 23 countries, followed by Mexico this June. An official at a securities company said, “We know that Hanmi has been working with MSD for several years to naturally exchange with the research institutes. There are more and more cases where the reliability accumulated from small exchanges extends to technology transfer”. The 2015 large-scale technology transfer agreement between Hanmi and Sanofi is similar. In 2013, the two companies jointly developed a high blood pressure/hyperlipidemic drug, Rovelito. It covers everything from product development to launch and marketing. Although there has been a change in the relationship between the two companies, including Sanofi's return of rights, there is no disagreement that past exchanges had a positive effect on LO. Small exchanges among Yuhan and Beringer-Gilliard led to big deal Yuhan Corporation is a similar case. Yuhan exported the pre-clinical (animal) NASH therapeutic substances to Beringer Ingelheim in July last year for a total of ₩1 trillion ($870 million). It is a scale that competes for the level among the pre-clinical license agreements in the domestic pharmaceutical industry. The contract amount is $40 million (about ₩45 billion). In 2010, Yuhan entered into a co-promotional agreement with Behringer’s Twynsta, since then, additional treatments for diabetes treatment drugs, Trajenta and Jardiance, are underway. In the early stages, partnerships were expanded as the performance of early joint sale items improved. The relationship between the two companies led to exchanges between research institutes. Based on the confidentiality agreement, they are sharing their research content with each other. In this process, in this process, it is known that exchanges with Yuhan's NASH treatment have also occurred. This is the same as the big deal between Yuhan and Gilead that occurred in January of the same year. Yuhan transferred another NASH therapeutic substance to Gilead Sciences at the time of US$785 million (₩882.3 billion). The down payment is $15 million (about ₩16.8 billion). This case was conducted in the phase of candidate substance discovery. It turns out that it was impossible without the exchange between the two companies. In 2012, Yuhan signed a co-promotional contract with Gilead's hepatitis B treatment drug, 'Viread'. Since 2017, it has been jointly selling various items such as hepatitis C treatment 'Sovaldi' and 'Harvoni', and HIV/AIDS treatment 'Stribild' and 'Genvoya'.
- Company
- SGLT-2 inhibitors growth surge by 30% in antidiabetic market
- by An, Kyung-Jin Aug 07, 2020 06:26am
- (Clockwise from left) Product image of Forxiga, Jardiance, Steglatro and Suglat In the South Korean oral antidiabetic drug market, the influence of sodium-glucose cotransporter-2 (SGLT2) inhibitors has expanded even further. The outpatient prescription sales in the medicine broke through the 50-million-won point as the single drug prescription is constantly growing and combination therapies have been effective. AstraZeneca and Boehringer Ingelheim, both owning SGLT-2 inhibitor single drug and combination drug, are strongly leading with 95 percent of the market. According to a pharmaceutical market research firm UBIST on July 31, six SGLT-2 inhibitor single drugs and combination drugs have raised 57.4 billion won in the first half of the year from outpatient prescription, surging 30.8 percent from last year same time at 43.9 billion won. Also compared to the first half of 2018 making 32.2 billion won, this year’s prescription sales soared by 78.2 percent. The antidiabetic medicine SGLT-2 inhibitor hinders reabsorption of blood glucose in kidney and induces excretion of the unused glucose through urine, which eventually lowers the glucose level in the blood. Unlike dipeptidyl peptidase 4 (DPP-4) inhibitors, the SGLT-2 inhibitors do not rely on insulin nor get affected by insulin resistance. Also the users have been positive about the medicine’s clinical evidence of weight loss effect and benefit in cardiovascular system. AstraZeneca and Boehringer Ingelheim have launched SGLT-2 inhibitor combination drugs following their single drug line-ups and started expanding the SGLT-2 inhibitor prescription. In the first half of the year, AstraZeneca’s Forxiga (dapagliflozin) generated 17.6 billion won in outpatient prescription and grew by 10.1 percent from last year. After signing a partnership deal with CJ Healthcare in September 2014, AstraZeneca released the first SGLT-2 inhibitor Forxiga in the Korean market. The new drug kept the leadership in SGLT-2 inhibitor market for six consecutive years since then. AstraZeneca is now claiming more of the market influence by becoming the first company to release SGLT-2 inhibitor plus metformin combination drug Xigduo. The combination therapy has raised 13.4 billion won in the first half of the year, which was 42.5 percent higher than last year. Monthly outpatient prescription volume of major SGLT-2 inhibitor drugs (Unit: KRW 1 million) Source: UBIST From 2018, AstraZeneca has started co-marketing Forxiga and Xigduo with a Korean partner Daewoong Pharmaceutical. The two drugs together have generated 31 billion won, taking up 54.0 percent of the market share. The research firm evaluated the global company’s early move and the Korean company’s sales forces have created a synergy effect. Boehringer Ingelheim’s Jardiance (empagliflozin) is the first SGLT-2 inhibitor to prove the benefit in cardiovascular system through EMPA-REG OUTCOME data and it is tailgating its biggest competitor closely. In the first half of the year, Boehringer Ingelheim’s Jardiance has made 16.8 billion won in outpatient prescription. With the growth of 66.7 percent from last year, the gap between the drug and the market leader Forxiga was narrowed down to 800 million won. A metformin combination drug Jardiance Duo have increased this year’s prescription volume by 150.6 percent from last year and generated 6.8 billion won. Boehringer Ingelheim’s Jardiance and Jardiance Duo have jointly made 23.6 billion won in the first half of the year and claimed 41.4 percent of the market. Considering AstraZeneca and Boehringer Ingelheim respectively took 68.0 percent and 27.6 percent of the SGLT-2 inhibitor prescription market, Boehringer Ingelheim’s market influence has surged immensely in a year. Currently, Boehringer Ingelheim’s Jardiance and Jardiance Duo are co-marketed under the joint partnership with Lilly Korea and Yuhan. Outpatient prescription market share of key SGLT-2 inhibitor products in the first half of the year (Source: UBIST) Astellas Pharma and MSD’s SGLT-2 inhibitor single drugs have shown a growth in prescription, but their market shares are still comparatively underwhelming. Astellas Pharma’s Suglat (ipragliflozin) has raised 1.6 billion won in the first half of the year with a growth of 16.7 percent from last year, but its market share is only at 2.8 percent. The company signed a co-marketing deal with Handok in April 2018 for the Korean company to be in charge of distribution, marketing and sales in Korea. MSD jumped into the SGLT-2 inhibitor market in late 2018 with Steglatro (ertugliflozin), but it has not been prominent. The drug made 1.1 billion won in the first half of the year. Compared to last year, the figure doubled but it only has the smallest 2.0-percent pie in the prescription market. Prior to the launch of Steglatro, MSD signed a co-marketing deal with Chong Kun Dang, which they have already formed a partnership over Januvia (sitagliptin). Although MSD and Chong Kun Dang together have made Januvia the number one DPP-4 inhibitor, Steglatro could not break away from the handicap of joining the competition late.
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- Hanmi signed a technology transfer of ₩1 trillion
- by Lee, Seok-Jun Aug 07, 2020 06:26am
- Hanmi signed a technology transfer agreement of ₩1 trillion ($860 million). The down payment is $10 million (₩12 billion), and the other side is MSD, a global US pharmaceutical company. Hanmi announced on the 4th that it has signed a license agreement with MSD to develop, manufacture and commercialize the biomedicine candidate 'LAPSGLP/Glucagon receptor dual agonist' as a therapeutic agent for NASH (non-alcoholic steatohepatitis). The generic name (INN) of 'LAPSGLP/Glucagon Receptor Dual Agonist' is 'Efinopegdutide' and the code name is HM12525A. The LAPSGLP/Glucagon receptor dual agonist is a dual-acting treatment that simultaneously activates GLP-1, which helps insulin secretion and appetite suppression, and Glucagon, which increases energy metabolism. Hanmi's LAPSCOVERY technology, which is based on drug efficacy, is applied. With this agreement, MSD will secure exclusive rights to the development, manufacture and commercialization of the 'LAPSGLP/Glucagon Receptor Dual Agonist' worldwide, excluding Korea. Hanmi will receive a confirmed deposit of $10 million and up to $860 million in milestones for clinical development, licensing, and commercialization by phase from MSD. After the product launch, it will receive a double-digit percent sales royalty.
- Company
- Belgium approved Expanded access of Remimazolam
- by Lee, Seok-Jun Aug 07, 2020 06:26am
- Hana Pharm announced on the 4th that the new drug anesthetic drug 'Remimazolam' was approved by the Federal Agency for Medicines and Health Products of Belgium for sympathetic use for COVID-19 critically ill patients. In recent years, the supply shortage of Propofol and Midazolam for the treatment of critically ill patients with COVID-19 has increased, and Remimazolam is being used to replace it. Expanded access is a system that permits the use of drugs that are under development or have not yet been approved for sale when there is no adequate therapy for a life-threatening and prolonged or severe illness. Remimazolam is currently licensed in Japan, the United States, and China. It was approved as an indication for 'induction and maintenance of general anesthesia' in Japan, and 'sedation under consciousness during surgery and diagnosis' in July. The original developer is Piaon of Germany, and Hana Pharm holds all rights in six countries in Korea and Southeast Asia. Approval is also expected in Korea and Europe.
