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- 2026-05-20 20:56:13
- Policy
- What criteria does the Pharmaceutical Committee judge?
- by Lee, Hye-Kyung Jan 14, 2020 08:49am
- 12 of 24 new drugs were successful in listed drugs, Unfortunately, there are four drugs that have failed the reimbursement challenge. The HIRA evaluates the adequacy of a drug through a review by the Pharmaceutical Benefits Evaluation Committee in accordance with Article 11 (2) of the Rules on National Health Insurance Benefits. Dailypharm analyzed new drugs that passsed by the HIRA's Pharmaceutical Benefit Committee from January to December last year. Of the 24 drugs, only 11 received reimbursed. The remaining 10 drugs were non-reimbursed, and 3 drugs were managed-entry. .Non-reimbursed drugs include 'Duodopa intestinal gel' (levodopa)' by Korea's AbbVie, 'Neuronata-R(autologous bone marrow-derived mesenchymal stem cells)' by Corestem, and 'Zerbaxa' (Ceftolozane/Tazobactam) by MSD Korea .Radicut(Edaravone), the treatment of amyotrophic lateral sclerosisby Mitsubishi Danabe, chose to withdraw its reimbursement during the drug price negotiations with the HIRA .◆Duodopa intestinal gel=This drug is Progressive Parkinson's disease drug with severe motor ups and downs despite Parkinson's drug treatment,and it was approved on April 6 2015, went through the Pharmaceutical Benefits Subcommittee on July 23 2015 and it was put on the Pharmaceutical Benefit Committee on March 21, 2019, four years later .However, the clinical data submitted by the pharmaceutical did not qualify as 'medical drugs deemed necessary for medical treatment' because clinically meaningful improvements such as prolonged period of survival have not been proved .As a result, it was concluded that ICER was impossible due to insufficient evidence, and drug prices suggested by the company were difficult to accept due to uncertainty .On the other hand, the related academics said that patients who are not controlled by existing Parkinson's disease drugs because they do not have adequate treatment in Korea are necessary for patients suffering from mental and physical pain and severe diseases due to exposure to medical blind spots .This drug is listed in the US, Germany, France, Italy, the UK, and Japan excluding Switzerland among A7 countries ◆Neuronata-R= This drug is used in combination with Riluzole to slow the progression of the disease in amyotrophic lateral sclerosis, went through the Pharmaceutical Benefits Subcommittee on March 21 2018, and it was put on the Pharmaceutical Benefit Committee on last April 25 .In patients with amyotrophic lateral sclerosis, clinical necessity was acknowledged by slowing functional decline than without Neuronata-R, The cost was higher than that of the alternative, and the corresponding cost effectiveness was unclear, and A non-reimbursement decision was made .The domestic neurology textbook mentions the approval of rare drugs in the applied products, and the stem cell treatment is introduced as a treatment under study in the ALS in clinical guidelines .However, Yakyeong said, “Riluzole is being given to Amyotrophic lateral sclerosis, and considering the possibility of substitution, it is hard to say that it is an essential drug for medical treatment” .The related academics also suggested that it would be advisable to review the Neuronata-R strains after the results of phase II and III studies have been reported .◆Zerbaxa=this drug received an item permit on April 7 2017 for complex intraperitoneal infections (with Metroidazole) and complex urinary tract infections (including Pyelonephritis) .The deliberation was conducted on November 21 2018, through the Pharmaceutical Benefits Subcommittee, and the deliberation was conducted by the committee on last June 20 .As a result of the deliberation, the clinical necessity is hardly considered inferior to the clinical treatment rate, but it was concluded by non-reimbursement due to the higher cost than the alternative drug .The relevant academics suggested that the introduction of an inferior therapeutic agent compared to Carbapenem has a clinical significance in the case of limited antibiotics against MDR-infected Gram-negative bacterial infections .Among A7 countries, Zerbaxa is registered in the US, Italy, the UK, and Japan .◆Radicut=This drug failed the reimbursement threshold in the 2018 but was reevaluated by the Third Committee in 2019 and was recognized for its adequacy .Radicut was approved as a drug that could slow the progression of dysfunction caused by amyotrophic lateral sclerosis, but the clinical necessity was recognized, but the cost was high .However, there are no drugs or treatments with the same therapeutic position, and it has passed the severity and social impact of the disease according to the risk sharing plan and the policy to strengthen health insurance coverage as a rare disease treatment drug .The problem was that Mitsubishi Danabe Pharma had been discussing reimbursement in Canada at the same time as Korea .However, Canada decided to refer to Korean drug prices, and withdrew Korea's reimbursement entry to enter Canada's reimbursement .At that time, Radicut was listed in the US and Japan among A7 countries .On the other hand, in order to be reimbursed again, submissions of new cost-effectiveness data should be evaluated and submitted to the Pharmaceutical Benefit Committee .
- Company
- Reimbursed ALL new drug Besponsa lands code at Big 5 fast
- by Eo, Yun-Ho Jan 14, 2020 06:29am
- After the green light from Korean health authority, the reimbursed Besponsa (inotuzumab) injection has quickly found its position on general hospitals’ prescription code list. According to pharmaceutical industry sources, an antibody-drug conjugate (ADC) prescribed for acute lymphoblastic leukemia (ALL), Besponsa injection has been listed for reimbursement in October last year and currently, landed its code on every Korea’s Big Five tertiary hospitals’ prescription code list. Drug Committee (DC) at Samsung Medical Center and Seoul Asan Medical Center passed the injection’s code, while Emergency DC at Seoul National University Hospital, Severance Hospital and Seoul St. Mary’s listed the code. Their prompt action proves how doctors had significant needs for Besponsa. Besposa’s reimbursed indications are for secondary or tertiary remission induction therapy in adult patient aged over 18 years with relapsed or refractory B-cell precursor ALL. To this day, the only therapy option a relapsed or refractory ALL patient could take for curing the condition is hematopoietic stem cell transplantation (HSCT). And for the patients to receive HSCT, they first have to reach complete remission (CR) before the procedure. So far, Glivec changed the whole landscape of chronic myelocytic leukemia (CML) in the leukemia treatment sector. Since then, a number of competitive target therapy options, such as Tasigna (nilotinib), Sprycel (dasatinib), and Supect (radotinib), were released in the market. But for acute leukemia, especially for ALL, there was no more novel treatment other than Blincyto. Compared to other existing anticancer therapy, Besponsa easily doubles CR rate and help the patient to go through HSCT and to get cured. Last year, National Comprehensive Cancer (NCCN) Guideline recommended Besponsa as a category 1 treatment option. A hematologic academic society official commented, “For patients with ALL, having an access t ADC or immunotherapy before their condition worsens would take them to completely different treatment landscape.” In the Phase 3 INO-VATE ALL trial, a randomized open-label study to compare Besponsa and other existing anticancer therapy, the CR rate or CR with incomplete platelet recovery (Cri) for patients treated with the ADC was 80.7 percent compared to 29.4 percent with chemotherapy. Also, 48 percent of patient administered with Besponsa had HSCT, demonstrating improved figure than the 22 percent patients treated with chemotherapy. Minimal residual disease (MRD) negative result indicates small number of cancer cells in the body after anticancer treatment and also provides important prognosis works as a prognostic factor. As for the clinical trial, patients treated with Besponsa showed MRD negative of 78.4 percent, and other group treated with chemotherapy showed 28.1 percent. Whereas two-year overall survival rate and three-year overall survival rate in patients treated with Besponsa reached 22.8 percent and 20.3 percent, respectively, comparatively higher than chemotherapy-treated patients with 10 percent and 6.5 percent, respectively.
- Policy
- New patent evasion strategy for Galvus follow-ons?
- by Lee, Tak-Sun Jan 14, 2020 06:28am
- A creative strategy to evade patent is attracting the pharmaceutical industry’s attention. If the strategy is found successful, pharmaceutical companies in Korea would be able to use it to evade the extended effective term of substance patent protection, as an alternative to the strategy of changing saline base of the original drug affirmed ineffective by the court. According to an industry source on Jan. 12, Korean companies preparing follow-on drugs of dipeptidyl peptidase-4 (DPP-4) inhibiting anti-diabetes treatment Galvus has presented a unique patent evading strategy unlike preceding ones. The companies are challenging the original’s patent by excluding an indication used as an evidence to extend the patent term. For instance, the follow-on drug would omit one out of five indications of Galvus Met 50 mg/850 mg tablet, specifically the indication for ‘treating a patient when sufficient blood sugar level control is impossible with metformin monotherapy.’ The industry claims follow-on drug without the indication would not infringe the extended term of the patent as it was used to extend the Galvus’ substance patent term for 26 months and 23 days. In fact, it was reported the vildagliptin-metformin 50 mg/850 mg tablet applied for approval on Dec. 24 last year, without the particular indication. And apparently, the follow-on drug developers, Korea United Pharm and Hanmi Pharmaceutical have filed defensive confirmation trial for the right of Galvus patent with the same strategy. The call would be made when Korea Intellectual Property Office (KIPO) decides whether or not to accept the follow-on drug developers’ claim. If KIPO affirms the companies’ claim, then United Pharm and Hanmi Pharmaceutical would be able to release their follow-on drugs within this year. It would be possible as Galvus’ other substance patent rejected from extension was expired Dec. 9 last year. And also those two companies may launch products regardless of Ahn-gook Pharmaceutical’s generic approved with preferential sales rights. After nullifying 187 days out of the extended patent term of 26 months and 23 days, Ahn-gook Pharmaceutical can legitimately start selling follow-on drug from Aug. 30, 2021. The company also won the preferential sales right to exclusively supply the vildagliptin generic from Aug. 30, 2021 to May 29, 2022. As a result, other drugs in the same class cannot be launched. However, the exclusive sales right is not effective on drug that completely evaded extended patent term. In other words, the follow-on drug developers could release their products before Ahn-gook Pharma. And this is not the first time the strategy has been used. Chong Kun Dang Pharmaceutical used the strategy to release benign prostatic hyperplasia (BPH) and hair loss treatment Avodart’s generic, Dutesmol, before the original’s extended patent was expired. Initially, however, Dutesmol’s indication did not include treating BPH as it was an evidence to extend the original’s patent. And after the substance patent was expired, the generic won the BPH indication and now the drug is available for prescription on treating BPH. Galvus follow-on drug developers are likely to exclude indication used to extend the original’s patent, but they are also likely to seek for approval on the omitted indication when the patent expires completely. As the old patent evasion strategy of changing saline base has been blocked by the Supreme Court’s decision made in January last year, the industry experts predict pharmaceutical companies in Korea have high chances of evading the extended term of the original’s patent protection by dropping an indication for their product. Currently, pharmaceutical companies that commercialized follow-on drugs with switched saline base from the original overactive bladder medication Vesicare and smoking-cessation treatment Champix have suspended their sales due to the Court of Appeals’ decision to affirm patent infringement.
- Policy
- Non-reimbursed Dupixent now covered with few conditions
- by Lee, Hye-Kyung Jan 14, 2020 06:28am
- Patients taking severe atopic dermatitis treatment Dupixent prefilled injection (dupilumab) as a non-reimbursement treatment option can now have an access to healthcare reimbursement without satisfying the newly established reimbursement criteria. Health Insurance Review and Assessment Service (HIRA, President Kim Seung-taek) published a Q&A on reimbursed use of Dupixent and presented detailed criteria of reimbursement. Starting from Jan. 1 this year, the Korean government cleared reimbursement on Dupixent for treating adult patient over the age of 18 with severe atopic dermatitis, who has uncontrolled condition after four-week topical treatment (corticosteroids or calcineurin inhibitor) as first-line treatment, and not showing more than 50 percent improvement in Eczema Area Severity Index (EASI) score after three-month systemic immunosuppressant therapy (cyclosporine or methotrexate); has EASI score over 23 before administrating the treatment; and has a record of receiving topical treatment and systemic immunosuppressant therapy within past six months. However, HIRA has also decided to provide reimbursement on patients, who have been treated with non-reimbursed Dupixent, if they qualify either one of two conditions, regardless of passing the existing reimbursement criteria. The two conditions are either having a record of receiving systemic immunosuppressant therapy (cyclosporine or methotrexate) after being diagnosed with atopic dermatitis or having a record of atopic dermatitis severity indicator (EASI over 23, SCORAD over 40, or IGA 4) without receiving systemic immunosuppressant therapy for medical reason. But for the new special case of reimbursement, a patient needs to apply for reimbursement by June 30 with detailed medical record and the dermatologic condition-related doctor’s referral to prove qualification of the condition. And for patients, who have been treated with systemic immunosuppressant therapy without testing EASI score prior to the treatment, have to submit SCORAD or IGA score indicating the severity of the atopic dermatitis. Nevertheless, the reimbursement would be given when the patient is tested before the Dupixent treatment and scores over 23 on EASI testing. For patients struggling with chronic atopic dermatitis over three years, the government agency has to confirm medical record of atopic dermatitis diagnosed three years before the date of first Dupixent treatment to grant reimbursement. Meanwhile, a patient omitting the systemic immunosuppressant therapy to immediately follow the first-line topical treatment with Dupixent treatment has to pay the full price of the treatment. However, a patient who is unable to receive the systemic immunosuppressant therapy due to medical restriction, such as renal failure, uncontrolled hypertension, uncontrolled infection, malignant tumor, and severe liver condition, but has qualifying EASI score can receive reimbursement.
- Policy
- Only 1 in 2 new drugs listed last year
- by Lee, Hye-Kyung Jan 13, 2020 11:30pm
- Of the 24 new drugs that were applied for benefits last year, 12 were successful in listed drugs, with the listing rate remaining at 50%. Dailypharm analyzed new drugs that were deliberated and voted by the HIRA's Pharmaceutical Benefit Committee last year. Of the 24 drugs, only 11 received reimbursed. The remaining 10 drugs were non-reimbursed, and 3 drugs were managed-entry. In particular, Radicut(Edaravone), a drug for treating Amyotrophic Lateral Sclerosis in Mitsubishi Tanabe Pharma Korea Co., Ltd, received a reimbursement judgment at the Pharmaceutical Benefit Committee, and chose the reimbursement withdrawal during drug price negotiations with the NHIS. At the time, Radicut had been discussing the reimbursement in Canada at the same time as Korea, and withdrew Korea's reimbursement entry to enter Canada's reimbursement. Korea's passing of drugs started with Novartis' asthma treatment ‘Xolair (Omalizumab)’ last year. 10 of the 13 drugs besides reimbursed determination were clinical benefits but received managed-entry due to higher cost than alternative drugs. Among these, 'Agotin' (agomelatin) of Whanin Pharmaceuticals, 'Faslodex' (Fulvestrant) of AstraZeneca, and ‘Biktarvy’ (Bictegravir) of Gilead Science Korea, accepted the proposed expenses presented by the HIRA and put them on the reimbursed list. Since five domestic companies applied for benefits at the same time, the treatment for chronic constipation of Prucalopride succinate, which was put on the level in last October, was also managed-entry, but only Yooyoung Pharmaceutical is expected to negotiate with the HIRA. Liporaxel (oral Paclitaxel) of Dae Hwa pharmaceutical get approved as a managed-entry in last November after two attempts, and is struggling whether to make a decision. There were four drugs which is non-reimbursed at the drug committee, and Non-reimbursement is determined when both relative clinical usefulness and cost effectiveness are unclear. To challenge again, new cost-effectiveness data must be submitted, evaluated, and the agenda should be addressed to Pharmaceutical Benefit Committee. Non-reimbursed drugs include 'Duodopa intestinal gel' (levodopa)' by Korea's AbbVie, 'Neuronata-R(autologous bone marrow-derived mesenchymal stem cells)' by Corestem, and 'Zerbaxa' (Ceftolozane/Tazobactam) by MSD Korea, Imfinzi (Durvalumab) by AstraZeneca.
- Company
- Tae-han Kim, CEO of Samsung BioLogics, attends JP Morgan
- by Lee, Seok-Jun Jan 13, 2020 06:27am
- Samsung BioLogics will present the main event space (Grand Ballroom) for two consecutive years at the JP Morgan Healthcare Conference. It is the first Korean company to make a main event space presentation. President Tae-han Kim makes a presentation by himself. Kim's attendance at the JP Morgan conference was unclear due to the prosecution's investigation into Samsung Biologics intentional accounting fraud. Tae-han Kim, CEO of Samsung Biologics, is presenting at the 2019 J.P. Morgan Healthcare Conference.Samsung BioLogics announced on the 12th that it will participate in the JP Morgan Healthcare Conference, the world's largest global investment event, held in San Francisco, USA. Samsung BioLogics was assigned the Main Track in 2017 and 'Grand Ballroom' last year and this year. Both are the first Korean companies. The Grand Ballroom is a large 800-seat presentation venue. Only a few major global pharmaceutical companies, such as Pfizer, Roche and Johnson & Johnson, are known to be assigned. The announcement will be made by CEO Tae-han Kim and Vice President John Lim. Samsung Biologics will present its achievements, 2020 goals, and mid- to long-term visions under the theme of 'Innovation and Growth of Samsung in Biologics Industry' in a presentation on Wednesday afternoon 15th. Meanwhile, the JP Morgan Conference, which marks its 38th anniversary this year, is the largest investment event in the healthcare sector, in which 500 pharmaceutical bio companies from around the world, invited by the global investment bank JP Morgan, announce major business results and visions.
- Policy
- Generic exclusivity for ₩50 million Betmiga applied
- by Lee, Tak-Sun Jan 13, 2020 06:26am
- The first generic drug of 'Betmiga' (Mirabegron, Astellas), a potent overactive bladder treatment, coming soon in June this year applied for permission. The interest in the industry is amplified because generic exclusivity are given exclusive rights to the generic market based on who first applied for the permit. According to the MFDS and the industry on the 10th, the application for permission of the Betmiga was received on Dec 31. Since the re-examination period for the Betmiga was expired on Dec 30, the application for authorization was submitted the next day, Dec 31. However, the number of licensed items and company names have not been disclosed yet. Currently, 11 Korean companies have established the basis for early entry into the market, excluding the material patents of Betmiga, winning the decision to invalidate crystalline invalid patents. Accordingly, the first applicant of the 11 companies is likely to obtain a generic exclusivity, which is granted generic market monopoly for nine months. The 11 companies are Hanmi pharmaceutical, Chong Kun Dang, JW pharmaceutical corporation, Daewoong Pharmaceutical, Ildong Pharmaceutical, Intro biopharma, Alvogen Korea, Kyungdong pharmacetical, Shinil Pharm Ltd, Hanwha Pharma Co., LTD, and Shin Poong Pharm. Co., LTD. However, all 11 companies did not submit the application for permission last month. Some companies have reportedly failed to demonstrate bioequivalence with the original drug. As such, only a few companies are likely to win generic exclusivity. Generic exclusivity is expected to be granted for nine months from the day after May 3, 2020, when the Betmiga’s patent expires. During this period, the same ingredient generics will not be released, so it is highly likely that the rights holder will preoccupy the market. Accordingly, companies that have acquired generic exclusivity are expected to conduct aggressive marketing and marketing during that period. Betmiga is a large item of about ₩50 billion per year. In 2020, it is expected that Betmiga’s generics will struggle over the market.
- Company
- Hana secured copyright for anesthetic drugs in 6 countries
- by Lee, Seok-Jun Jan 13, 2020 06:26am
- Hana Pharm Co. announced on the 9th that it signed an exclusive contract with six countries in Southeast Asia for anesthetic drug, Remimazolam. Remimazolam is a new anesthetic drug that is considered to be a Propofol alternative. After finishing phases III in each country, they are getting global approval for Japan, USA and Europe. The original developer is Paion by Germany, and Hana has acquired the rights of six Southeast Asian countries following Korea. According to the disclosure, Southeast Asian countries are Vietnam, Indonesia, Thailand, Philippines, Singapore and Malaysia. The other party is Paion and the contract is €1.5 million (about ₩2 billion). Phased permits, launches, and sales-linked milestones will be paid separately. Remimazolam has a global license ahead. Depending on the country partner, Japan's Mundipharma issued a permit application in December 2018, Cosmo Pharmaceutical U.S.A., 2019, and European Paion in November. In Korea, Hana completed the application for approval on December 30 last year. It is likely to be the first to be approved in Japan. If the permit is granted, it will have a positive effect on domestic approval. OEM Europe and Japan Export Challenge Hana is setting export targets for Europe and Japan in addition to the Remimazolam copyright contract. The region plans to advance to Paion's 2nd Vendor OEM. There are only four Remimazolam producers in the world, including Hana. Hana's strategy is to establish a global market base through Southeast Asian copyright and European and Japanese consignment production. Hana is also expanding its facilities to meet the demand for Remimazolam. Hana decided to invest ₩58.5 billion in November to construct a new injection plant and introduce facilities. The new plant's production capacity is estimated at ₩200 billion for injection. Operation is expected in 2022. In last February, the facility invested. In order to secure the site for the new factory, the company purchased the sale of the Pyeongtaek Dreamtech General Industrial Complex. Kepa has not been decided yet, but the new plant will be completed by 2025. An official of the company explained, "Remimazolam can be produced in existing factories, but is investing in facilities to meet the growing demand".
- Policy
- Certican price reduced by ATP to KRW 5250 for 1mg
- by Kim, Jung-Ju Jan 13, 2020 06:22am
- The price of Novartis’ immunosuppressant Certican (everolimus) was lowered on Jan. 9, as a result of the recent actual transaction price (ATP) survey on reimbursed drugs. The price could be further adjusted when the final decision is made from the administrative litigation between the company and government about ex-officio adjustment of the drug pricing. On Jan. 8, Korea’s Ministry of Health and Welfare (MOHW) has issued the partially revised ‘List of Reimbursed Drugs and Maximum Reimbursement Price’ reflecting the price change. Last year, the government surveyed ATP of drugs supplied to healthcare institutes to calculate weighted average value, and lowered maximum reimbursed price of each drug item by no more than ten percent according to the survey result and calculation. Currently, Certican is in the midst of administrative litigation against the government’s decision to lower the drug pricing by 30 percent due to a first generic listing, but the company has requested for suspension on enforcement of the ex-officio adjustment. If the request had not been accepted by the court, the drug pricing would have been lowered by more than the ATP-based price reduction rate, which would not have been reflected. While the company is maintaining the original pricing with last year’s adjustment is suspended by the prolonged litigation, the government had to lower Certican’s pricing by ATP-based reduction rate like any other drugs. Accordingly, the new reimbursed maximum prices of Certican in different doses are 2,266 won for 0.25 mg, 3,617 won for 0.5 mg, 4,450 won for 0.75 mg and 5,250 won for 1.0 mg.
- Company
- Sanofi recruits 4943 patients in three clinical trials
- by Chon, Seung-Hyun Jan 13, 2020 06:22am
- Hanmi Pharmaceutical's new technology, "Efpeglenatide", exported to Sanofi, continues commercializing smoothly.. Three cases were recruited out of five phase III trials. In three clinical trials, a total of 4943 patients were recruited, accumulating the scientific evidence to prove the competitiveness of Efpeglenatide. The whole view of Hanmi Pharmaceutical HeadquartersAccording to Clinical Trials, a clinical information site run by the National Institutes of Health (NIH), Sanofi recently completed a recruitment of one of the Phase III trials of Efpeglenatide. This is a Phase III clinical trial comparing the combination of Efpeglenatide and Metformin with the competing drug Trulicity ( Dulaglutide). Sanofi began the trial in September 2018 and after enrolling 481 subjects, changed the clinical stage to “Active, not recruiting” on the 7th.. The target completion date is next February. Sanofi has completed three of the five trials of Efpeglenatide in Phase III trials. Efpeglenatide is a GLP-1-based diabetic drug that extends daily injections from once a week to up to once a month. It is based on Hanmi’s 'Lapscovery' technology. Lapscovery is a platform technology that increases the short half-life of biopharmaceuticals and reduces the number of doses and dosages to reduce side effects and improve efficacy. Hanmi signed a technical export contract with Sanofi’s Efpeglenatide in November 2015, and holds the record of the largest contract ever for four years. In November 2015, Hanmi signed a contract with Sanofi to export technology for a total of €3.9 billion in quantum projects (Efpeglenatide·sustained insulin· Efpeglenatide·sustained insulin). The down payment is €400 million. In December 2016, Hanmi signed an amendment agreement with Sanofi to return one of its technology transfer projects. Hanmi returned €196 million to Sanofi out of the €400 million received from Sanofi. Sanofi announced a detailed development plan at the end of 2017, two years after taking the rights of Efpeglenatide. Sanofi began five clinical trials in late 2017 after the first phase III trial comparing Efpeglenatide to placebo. In last June, 4076 people were enrolled in the AMPLITUDE-O, which is considered the core clinical trial of Efpeglenatide. In last October, the recruitment of AMPLITUDE-M compared to placebo was completed. A total of 4943 patients were enrolled in the three clinical trials that were completed. It is accumulating scientific evidence to secure market competitiveness while demonstrating the safety and effectiveness of Efpeglenatide in large patients. Efpeglenatide survived the reorganization of Sanofi's harsh R&D pipeline. Efpeglenatide is the only diabetic drug among the five R&D pipelines that Sanofi has set for NDA within two years. Sanofi suddenly stopped developing GLP-1 based triple agents (SAR441255) last year. It also returned the rights of the SGLT-1/2 double inhibitor ‘Zynquista(Sotagliflozin)’, which was introduced in 2015. Sanofi announced in last December that Sanofi increased its investment in four areas: cancer, blood disease, rare disease, and nervous system disease and stopped research into cardiovascular disease. Efpeglenatide is in a position to complete development and search for a new vendor.
