- LOGIN
- MemberShip
- 2025-12-25 15:34:14
- Company
- The cumulative sales of Biktarvy amounted to ￦60 billion
- by Sep 30, 2021 05:56am
- Gilead Science's Biktarvy dominated the AIDS tx market around the world, including Korea, two years after its launch. Biktarvy consists of Bictegravir Sodium, Emtricitabine, and Tenofovir Alafenamide Fumarate as Gilead's HIV treatment. Compared to conventional treatments, the effectiveness and safety are improved, the expression rate of resistance is low, the pill size is small, and it can be administered regardless of meal. After obtaining approval from the MFDS in January 2019, Biktarvy entered the market in earnest by applying benefit in July of the same year. According to IQVIA, a pharmaceutical market research firm, Biktarvy's sales increased to 4.6 billion won in the first quarter of its launch. In 2020, quarterly sales increased to 6.6 billion won, 7.9 billion won, and 9.8 billion won, respectively. It recorded 10.5 billion won in the first quarter of this year. Until the second quarter of this year, cumulative 24-month sales amounted to 59 billion won. In June 2019, just before the launch of Biktarvy, the HIV market had Genvoya and GSK's Triumeq. Genvoya and Triumeq accounted for 44.3% of cumulative market share over the year. Biktarvy recorded a cumulative market share of 19.4% over a year in June 2020, one year after its launch. In June this year, the market share was 38.3%, surpassing both Triumeq and Genvoya. As a result, Biktarvy topped the domestic HIV treatment market in the shortest time. This is because at the time of introduction in Korea, the time required from permission to notification was reduced to one-fifth, and permission and insurance benefit registration were completed in about 100 days. Gilead successfully made a replacement from Genvoya to Biktarvy. Biktarvy has already been a blockbuster in the global HIV treatment market. It posted about 8 trillion won in global sales last year, up 53.1% from about 5 trillion won a year earlier. Biktarvy ranked ninth in the world's most sold medicine last year. This is the first and only HIV treatment to be ranked in the top 10 in sales. Leading global HIV trends is analyzed as a factor in sales. Even in the COVID-19 pandemic, Biktarvy is recommended as a primary treatment. The BHIVA issued guidelines for ART to be applied to HIV-infected people in August last year, recommending Biktarvy as the only initial treatment drug among HIV treatments. It emphasized, "HIV infected people have a higher risk of COVID-19 death than the general population, so they should receive ART treatment, and it is important to use drugs that can effectively control the virus." Another HIV treatment trend is RapIT (Rapid Initation of Treatment). RapIT recommends major guidelines such as the WHO and IAS that treatment begins quickly within up to seven days of HIV diagnosis. Unlike other treatments, Biktarvy is considered a drug that meets the rapid treatment trend because it does not contain ABC and does not limit the virus level or CD4+ level of infected people. The DHHS recommends that acute and new HIV-infected people can start treatment through Biktarvy before confirming the results of genetic drug resistance tests. Biktarvy is the first and only HIV treatment to contain symptoms and emotional conditions that patients feel in their daily lives. In the PRO, patients evaluated that Biktarvy improved nausea, vomiting, sleep disorders, and fatigue compared to existing treatments, so patients' satisfaction was high. An official from Gilead Science Korea said, "Biktarvy has become the world's most prescribed HIV treatment, proving its strong and long-lasting virus suppression effect and long-term safety through the combination of upgraded integrated enzyme inhibitors and proven effective TAF drugs." He also said, "We will provide a good treatment experience for patients in need of drug switching and strengthen patient-centered marketing activities."
- Company
- SK C&C-GC Pharma, establish a big data platform for healthca
- by Chon, Seung-Hyun Sep 30, 2021 05:56am
- SK C&C announced on the 27th that it will carry out a project with GC Pharma Holdings to build a comprehensive healthcare big data analysis platform based on artificial functions (AI). During the project period, the two companies analyze and map various standard medical data based on the "cloud-type digital platform" and conduct AI convergence analysis activities based on domestic and foreign medical big data. "Cloud-type digital platform" is an all-in-one package platform that allows field practitioners to easily and quickly create necessary AI big data analysis models using AI, big data, cloud, and blockchain platforms and solutions without establishing a separate development environment. The company explains that cloud-type digital platforms allow users to freely develop various digital systems and services. The agreement was promoted with the aim of discovering new businesses related to digital healthcare through integration and analysis of data distributed to affiliates under GC. Starting with this agreement, the two companies will consider digital transformation for all affiliates under GC in the future. It plans to integrate distributed data from each company and collaborate closely in research and service solution development in the field of digital healthcare. Lee Jin-cheon, executive director of GC's Digital Transformation Office, said, "We will actively utilize domestic and foreign medical big data and DT technologies to strengthen our business capabilities in the digital sector and focus our capabilities on securing future competitiveness." Lee Ki-yeol, general manager of SK C&C's Digital Platform, said, "We will faithfully play a role as a digital transformation partner for GC Group, which plays a pivotal role not only in vaccine and new drug development but also in digital healthcare."
- Company
- Generic for Xarelto is about to be released.
- by Kim, Jin-Gu Sep 30, 2021 05:56am
- Bayer's new oral anticoagulant (NOAC) Xarelto (Rivaroxaban)' generic is imminent to be released. In particular, Hanmi, which received generic exclusivity, plans to release Xarelto 2.5mg exclusively, and Hanmi has a patent dispute with Bayer, drawing keen attention to the future response of the two companies. According to the pharmaceutical industry on the 24th, the Xarelto material patent will expire on the 3rd of next month. Generic for Xarelto will be released after the 4th of next month. In the case of the rest of the patents, Generic companies have succeeded through a Supreme Court ruling late last year. 133 generics for Xarelto are expected to be listed as starting next month. A total of 66 generic companies are expected to release generics for Xarelto 10mg and 15mg products, respectively. Hanmi's Riroxban 2.5mg was the only one to succeed in registering benefit. Hanmi is expected to release Riroxban 2.5 mg at the same time along with Riroxban 10mg and Riroxban 15mg. ◆ Bayer and Hanmi have registered their patents for use after obtaining generic for exclusivity In the case of Riroxban 2.5mg products, patent disputes still remain. This is because Bayer belatedly registered a patent for use in Riroxban 2.5mg after acquiring Hanmi's generic exclusivity. Hanmi and SK Chemicals challenged patent for Xarelto 2.5mg in March 2015. In November of that year, the two companies won the first trial. Then, as the two companies applied for permission for the first time, in July 2016, the two companies succeeded in obtaining generic for exclusivity. However, in September 2019, Bayer Xarelto 2.5 mg newly registered a patent for use. The patent expires in June next year, more than two years after acquiring generic for exclusivity. Since the new registration of the patent for use, the indication of Xarelto 2.5mg has also changed. Initially, Xarelto monotherapy was approved for the purpose of "reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation."However, after the registration of the patent for use, the combination therapy with Aspirin changed to "reduction of the incidence of atherosclerotic events such as myocardial infarction and stroke." ◆Will legal disputes continue? Riroxban's sales impact will be minimal The pharmaceutical industry predicts that it will lead to legal disputes between Bayer and Hanmi. Some predict that even if the two companies have legal disputes, sales of Riroxban 2.5mg will not be significantly disrupted. An official from the pharmaceutical industry said, "There was no problem with the approval of Riroxban 2.5mg after patent avoidance." However, if it is actually sold, there is a possibility that Bayer will raise the issue in the future, he said. ◆After the 4th of next month, it is predicted that generics for Xarelto such as Riloxvan will be released
- Company
- ST Pharm’s new cash cow ‘oligonucleotide’
- by Kim, Jin-Gu Sep 28, 2021 05:54am
- The oligonucleotide API business has become a major business of ST Pharm. The company has signed many deals over the past three years and the expansion and expectations for contract extensions have also greatly contributed to improving the company’s performance. Experts expect the oligonucleotide API business to stay as a cash cow for ST Pharm for a decade to come, with the global surge in demand for oligonucleotide API and the fact that most contracts signed by ST Pharm are long-term contracts. On the 27th, ST Pharm publicly announced that its oligonucleotide API supply contract with a biotech firm A in the U.S. has been expanded. In November 2019, ST Pharm had signed a contract with the company to supply 5 batches (150kg) of raw materials for clinical trials. The contract at the time was signed for ₩13.6 billion. Company A had requested to add 1 batch to its contract. With the request, the ST Pharm will be supplying a total of 6 batches (180kg) of its API to Company A. The contract amount also increased to ₩18.1 billion with the added ₩4.5 billion. With the addition, ST Pharm’s total contract for oligonucleotide has increased to ₩270 billion, which is more than twofold the sales made by the company last year. Since November 2017, the company had made a total of 14 deals to supply oligonucleotide API to companies, with most of the deals made in the past 3 years since 2019. ST Pharm had jumped into the oligonucleotide API business in 2018 after completing its Banwol plant in 2018. With its API business on track, the company’s performance has significantly improved. ST Pharm had recorded an operating loss for 9 consecutive quarters from Q2 2018 to 3Q 2020, then marked a turnaround in Q4 last year. The company e explained that its oligonucleotide API business was the cause of the turnaround. ST Pharm’s turnaround is drawing greater expectations as most of ST Pharm’s oligonucleotide API deals being long-term contracts. Industry experts foresee that its oligonucleotide business will contribute as a stable cash cow for 10 years at the most. The company has completed delivery of ₩80 billion’s worth of APIs from the ₩270 billion contracts. This means that the company still has around ₩190 billion left to be reflected in its performance from 2H this year to 2023. Also, expectations for additional sales being made from contract extensions exist. Most of the company’s contracts are for the supply of raw materials for clinical trials or initial commercialization. Therefore, if the drug succeeds in commercialization and enters full-scale production, this may lead to further requests for more supply of oligonucleotides.
- Company
- First progress to SGLT2i combo reimb. made in 3 years
- by Eo, Yun-Ho Sep 27, 2021 05:52am
- Patients in Korea have come one step closer to receiving reimbursement extensions to SGLT-2 inhibitor combos. This is the first progress that has been made in three years. According to industry sources, the diabetes expert committee that was convened by the Health Insurance Review and Assessment Service earlier this month concluded in the direction of integrating and allowing reimbursement for DPP-4 inhibitor and SGLT-2 inhibitor class and triple therapy combos. However, regarding TZD class drugs with cardiovascular issues, the committee decided to determine the combined use of each TZD class drug separately. Therefore, prescription restrictions on the use of TZD in combos are expected to continue. HIRA is currently discussing formal procedures, including when to put the agenda up for deliberation to the Pharmaceutical Benefit Assessment Committee. The issue has been ongoing for almost 3 years since 2018 when the government’s proposal to ‘amend the reimbursement standards to approve combined use of drugs by class’ to improve convenience and coverage for the patients. However, the amendment was put on hold due to the lack of efficacy data in some drugs that have no clinical studies conducted, and the academia’s opposition that reimbursement should be only allowed according to each drug’s indication. However, academia had first ignited the discussion on expanding reimbursement for diabetes drug combos as the different indications of drugs in the same class lead to confusion in the field and insurance cuts. The case was no different in 2013 when reimbursement was extended to DPP-4 inhibitor and thiazolidinedione class drug combinations. However, the end results were completely different. However, academia, which had always stressed the importance of clinical experience and expert judgment over indications or fiscal impact, had made a very different decision for the use of SGLT-2 inhibitor combos. As a result, the ‘class effect’ of SGLT-2 inhibitors were the only ones not recognized under the reimbursement standards among all oral diabetes drugs in Korea. However, academia had later submitted a statement recognizing the need for reimbursing SGLT-2 inhibitor combos, under which the MFDS had announced that it will ‘simplify’ the method of listing indications of diabetes treatments from ingredients to just ▲single or ▲combination therapy. And HIRA came to a positive conclusion this time. Currently, four SGLT-2 inhibitors - ‘Forxiga (dapagliflozin),’ ‘Jardiance (empagliflozin),’ ‘Suglat (ipragliflozin),’ and ‘Steglatro (ertugliflozin) – are being sold in Korea. For all 9 DPP-4 inhibitors in the Korean market to establish grounds for combined use according to principle, clinical studies on 36 combinations need to be conducted. In the same sense, 8 clinical studies are required to establish evidence for the combined use of 2 TZDs and 4 SGLT-2 inhibitors.
- Company
- Eliquis generics pull out from market after losing suit
- by Kim, Jin-Gu Sep 27, 2021 05:51am
- With major Eliquis (apixaban) generics products removed from the insurance benefit list after losing the patent suit, the Eliquis generics have now completely withdrawn from the market. As a result, the only dispute left between the original and generic companies for Eliquis is the claims for damages, and a fierce legal battle is expected on the calculation of compensation for damages. According to the pharmaceutical industry on the 23rd, 26 products (13 companies) of Eliquis generics were removed from the reimbursement list this month. The drugs include Chong Kun Dang’s ‘Liquisia,’ Samjin Pharm’s ‘Elxaban,’ Yuhan Corp’s ‘Yuhan Apixaban,’ Hanmi Pharm’s ‘Apixban,’ and Jeil Pharmaceutical’s ‘Jerixaban.’ The other generics that were left on the reimbursement list were drugs that haven’t been sold after listing. With the removal, the market withdrawal of Eliquis generics has been officially complete in 2 years since the generics were released in the market. Chong Kun Dang and others had succeeded in targeting Eliquis’ substance patent in February 2018 (first trial), then succeeded in nullifying Eliquis’ composition patient, which led to the sequential release of its generics from June 2019. However, the situation took a downturn with the Supreme Court ruling, which overturned the first and second trial and ruled in favor of the original company. Companies that sold Eliquis generics voluntarily discontinued sales of their products to reduce the claims for damages from patent infringement. With the exit of the generics, the only dispute left between the original and generic companies is the compensation suit filed by BMS against generic companies. BMS filed a claim for damages against generic companies in 2019. However, the progress of the damages suit was sluggish as the Supreme Court ruling remained. And after the Supreme Court ruling came out in April, not many further pleadings were held due to the influence of the COVID-19 incident. The pharmaceutical industry predicts that lawsuits for damages will speed up with the Supreme Court ruling. And a fierce battle between the two sides is expected over how the specific amount for damages will be set. In general, the amount of damages for patent infringement is set at 14.2% of actual sales sold for each generic, as the judiciary considers the operating profit of the industry to be around 14.2%. However, the calculation becomes much more complex when damages are specifically calculated by category because the 'profit' made from patent infringement is considered the amount that should be compensated for damages. For example, the cost of the raw material sand APIs is generally excluded from charges, because the ingredients would not have been purchased if not for the generics’ release. Calculation of labor, sales, and promotion expenses is more complex. This is the part where the two parties clash the most. As each generic company invests different amounts in labor, sales, and promotion expenses, the original company is having the most trouble calculating this amount. Also, some have mentioned that the original company is preparing new reasoning to increase the compensation that should be paid by generics companies. Until recently, generic companies have earned a total of 12.7 billion won in 2 years by releasing Eliquis generics. According to the pharmaceutical market research firm UBIST, Liquisia earned 4.1 billion won; Elxaban 2.4 billion won; Yuhan Apixaban 1.7 billion won; and Apixaban 1.1 billion won. An industry official said, “Based on previous rulings, the generic companies will have to pay around 1.8 billion won in compensation for damages incurred, so each company will be paying less than 0.6 million won. However, the companies may have to pay more under the new reasoning the original company is preparing.
- Company
- When does Sputnik ship in Korea?
- by Kim, Jin-Gu Sep 27, 2021 05:51am
- SputnikShipment of the domestic finished product of the COVID-19 vaccine Sputnik developed in Russia will begin as early as next month. The consortium centered on Korus has already secured 10 million finished products, and the Huons Global Consortium plans to start producing finished products by the end of this year. ◆Prospects of shipment of finished products next month, Russian media also report "imminent" According to Korus on the 17th, the Korus consortium, which consists of seven companies and institutions, plans to ship the finished product of Sputnik as early as next month. Korus has already started producing finished products and has completed the production of undiluted solutions for 10 million people. An official from the company explained that if a request is received from RDIF, it can be shipped immediately after filling. Korus has completed the submission of relevant data and is waiting for certification from the Russian government. It explains that initial shipments are possible as soon as authentication is completed. There have also been reports in Russia that shipments are imminent. Russian news agency TASS reported on the 16th (local time) that GL Rafa will ship Sputnik Light in the near future, and RDIF is planning a commemorative event related to this. Huons Global product production has begun, "The forecast of production of finished products by the end of this year Korus signed a contract with RDIF for consignment production of Sputnik V in September last year. Since then, Korus has formed a consortium with six companies and one institution, including Binex, Boryungbio, Isu Abxis, CKD Bio, Quratis, and Andong Animal Cell Demonstration Support Center. The consortium plans to build production facilities of more than 100 million doses per month. However, as product production and local approval were delayed due to local circumstances in Russia, questions were raised over the specific timing of shipment of finished products. An official from Korus said, "We signed the first Sputnik V consignment production contract, but with the release of Sputnik Light, which was improved with one inoculation, the originally planned schedule has been slightly delayed," adding, "We expect to be able to ship as early as next month." ◆Huons Global product production has begun, The forecast of production of finished products by the end of this year Huons Global Consortium also predicts that it will be possible to produce finished products within this year. Prestige Biopharma, Humedix, and BoranPharma are participating in the Huons Global Consortium. Huons Global announced on the 17th that it has started production of Sputnik V's products since this week. Prestige Biopharma is in charge of this production. Prestige Biopharma is in charge of manufacturing undiluted solutions at the Huons Global Consortium. After a Russian official checks the product, a Huons Global official predicted that production of the finished product will be from November to December. A meeting with Russian officials last August with Huons Global Consortium An official from Huons Global said, "It is expected that the validation confirmation process will be completed within this month. We will be able to start producing finished products within this year, he said. The produced products will be supplied to more than 70 countries that have approved Sputnik at the request of Russia, he said. Huons Global signed a contract with RDIF for consignment production of SputnikV in April.
- Company
- Celltrion signed a contract with the U.S. for DiaTrust
- by Lee, Seok-Jun Sep 24, 2021 05:56am
- Celltrion will supply DiaTrustTM COVID-19 Rapid Test, co-developed with Humasis, an in vitro diagnostic company, to the United States through Celltrion USA. According to the company on the 23rd, Celltrion USA was finally selected as a supplier in a purchasing project conducted by DLA under the U.S. Department of Defense. As early as the 1st of next month, it will begin supplying DiaTrust to 25,000 designated procurement sites in the United States, including military facilities, nursing homes, regional inspection centers, and major facilities. The contract period is until September 16 next year. The contract amount can increase by up to 738.2 billion won depending on the situation, the largest among the selected suppliers. An official from Celltrion emphasized, "The fact that we participated as a supplier in the U.S. defense procurement project, which has strict standards, has been recognized for Celltrion's technology and supply capabilities." Unlike other rapid diagnostic kits, DiaTrust is a product that improves sensitivity and specificity by applying two antibodies that bind to the N protein and S protein of the COVID-19 virus, respectively, and can check for infection within 15 minutes. It is possible to check for infection immediately after examination without additional equipment, and it shows accuracy of 93.3% sensitivity and 99.0% specificity. DiaTrust is divided into POCT and OTC that can be used with the help of medical experts under permission to use. This contract is supplied as POCT.
- Company
- Trelegy Ellipta can be prescribed at general hospitals
- by Eo, Yun-Ho Sep 23, 2021 05:44am
- The COPD treatment Trelegy Ellipta can be prescribed at general hospitals. According to related industries, GSK Korea's COPA treatment Trelegy Ellipta (Fluticasone Furoate, Umecridinium Br, Villanterol Trifenate) passed DC at 38 medical institutions including Big 5 General Hospitals such as Seoul National University Hospital and Asan Medical Center. Since the insurance benefits in June, prescriptions have become possible quickly. Trelegy Ellipta is the first COPD complex approved in Korea in May 2018. It is prescribed as a maintenance therapy for moderate and severe COPD that is not properly controlled by persistent β2 agonist and inhalation corticosteroid combination therapy or LABA and LAMA combination therapy in adults. As for the benefit criteria, despite ▲ persistent beta 2 agonist and LAMA combination therapy, if FEV1 value is less than 60% of the normal prediction or acute exacerbation occurs more than twice a year, ▲If symptoms such as dyspnea are not properly controlled despite persistent beta 2 agonist and inhalation corticosteroid combination therapy, ▲If a patient who is simultaneously administering Vilanterol trifenate/Fluticasone furoate and Umecridinium Br satisfies each individual examination, this is the case when pt wants to switch to Trelegy. The validity of Trelegy Ellipta has been reaffirmed through a recent INTREPID phase 4 study. The study was conducted at 147 centers in five European countries, including the UK and Germany, with a total of 3,092 COPD patients participating. Patients were assigned to the Trelegy Ellipta treatment group and the multiple inhalation type three-drug combination treatment group on a one-to-one basis. The primary efficacy evaluation variable was the COPD Assessment Test (CAT) score, which is the COPD evaluation test, to evaluate patients' health status. As a result of measuring the ratio of patients whose CAT score decreased by more than 2 units to baseline at the 24th week of treatment, the median CAT score in the patient group treated with Trelegy Ellipta was 18.0 (8.0), and the median CAT score in the multiple inhalation groups was 19.1 (7.9), significantly improving overall health. The secondary efficacy evaluation variable based on the sub-analysis was the change in FEV1 identified at week 24 of treatment and the proportion of patients who committed more than one serious error when using each inhaler. As a result of the analysis, FEV1 in the Trelegy Ellipta treatment group was 77 mL, which showed statistically superior lung function improvement compared to the multiple inhalation treatment group (28 mL).
- Company
- It surpassed ₩1 trillion in monthly drug imports
- by Kim, Jin-Gu Sep 23, 2021 05:43am
- In August, pharmaceutical imports surpassed ₩1 trillion for the first time. This is due to the fact that imports of Pfizer, Moderna vaccines were reflected in statistics following July. Drug exports rose 10% year-on-year to ₩700 billion last month. However, as imports increased sharply around the COVID-19 vaccine, the deficit in the drug trade balance hit the highest level since December 2019. ◆In August, vaccine imports amounted to ₩340 billion, the highest ever According to the Korea Customs Service on the 15th, imports of domestic medicines in August were $870.81 million. This is the first time that monthly drug imports have surpassed 1 trillion won. Compared to $50.32 million in August last year, it jumped 64%. It renewed its highest import amount ever for two consecutive months following July. In July, drug imports amounted to $819.58 million. As imports of COVID-19 vaccines began in earnest, the total amount of medicines imported increased significantly. Domestic vaccine imports were only $34.45 million by February this year, but as COVID-19 vaccine imports began in earnest, they surged to $49.82 million in March, $54.91 million in April, $58.88 million in May, $15.51 million in June, and $211.62 million in July. It recorded $291.53 million in August, once again breaking the record for the highest amount set in July. Considering that the domestic supply of Moderna vaccine has been disrupted in July and August, it is predicted that vaccine imports may increase further after September. Excluding vaccine imports, monthly drug imports remain around $600 million, similar to last year. ◆Pharmaceutical exports amounted to ₩690 billion, the largest trade deficit in 20 months Exports of medicines in August amounted up to 10% from$50.303 million a year earlier. As imports increased significantly compared to pharmaceutical exports, the domestic pharmaceutical trade deficit increased significantly. The drug trade balance recorded a deficit of $277.78 million in August. The deficit is the largest in 20 months after recording $317.24 million in December 2019. The domestic drug trade balance has steadily recorded a surplus from August last year to March this year, except for October last year, due to increased biosimilar exports. However, since the import of COVID-19 vaccines began in earnest, the deficit has gradually increased.
