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- 2026-03-18 22:46:43
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- 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.
- Company
- 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.
- Company
- AstraZeneca’s love for Korea expressed through investment
- by Lee, Seok-Jun Aug 05, 2020 06:26am
- A British-based multinational pharmaceutical company AstraZeneca is expanding its investment in the South Korean pharmaceutical industry. Recently, the company inked a deal with SK Bioscience on supplying COVID-19 vaccine as it saw the promising potential of the Korean industry. AstraZeneca’s investment on the Korean pharmaceutical industry has continued for years. The company had various instances recently, where it delivered the promise of investment made years ago and made new partnership with the Korean industry. Among all global pharmaceutical companies operating in Korea, the British company is considered one of the most active investor of the Korean pharmaceutical industry. The Korea Health Industry Development Institute (KHIDI) and AstraZeneca Korea announced yesterday that the seventh Anticancer Research Support Program has selected four new open innovation research plans. The long-term project has selected overall 28 research topics so far, or four cases annually for last seven years since 2014. The anticancer research support program is an event the KHIDI and AstraZeneca Korea jointly organize to provide support on promising basic science research topics related to preclinical test or translational research to expand open innovation in Korean healthcare industry and strengthen Korea’s pharmaceutical industry competitiveness. And on July 21, the global company signed a partnership agreement on the internationally most sought after COVID-19 vaccine. AstraZeneca, SK Bioscience and Ministry of Health and Welfare (MOHW) have agreed to collaborate on globally supplying AstraZeneca’s COVID-19 vaccine in development (ADZ1222). AZD1222 is the first one to enter the Phase III clinical trial among all COVID-19 vaccines in development. According to the agreement, SK Bioscience would be one of global partners to serve a role of a CMO manufacturing drug substance and processing ‘fill and finish’ of the vaccine. The ministry would expedite the both companies complying the agreement and lead the discussion on procuring the vaccine in Korea. Years of investment promises delivered The AZD1222 partnership is actually a follow-up action of the MOU signed in December last year aimed to collaborate in enhancing the Korean biohealth industry development. The company kept its word on the six-month-old promise. Last year, AstraZeneca signed MOU with four partners including Korea Trade-Investment Promotion Agency (KOTRA), KHIDI, Korea Biotechnology Industry Organization (KoreaBio) and Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA). These MOUs were products of five years of investment and collaboration plans made in June 2016. The symposium on accelerating big data and AI-based new drug development convened by AstraZeneca and the British Embassy Seoul in July 2019, and a conference on supporting Korean bio companies entering the Chinese market organized by AstraZeneca and Korea Biomedicine Industry Association (KoBIA) in September 2019 were also part of the 2016 investment plan. Another major collaboration between the global company and Korean industry took place in January 2018. AstraZeneca and SK Biotek signed a partnership deal in pharmaceutical manufacturing and production. And as a result, antidiabetic drugs manufactured by the Korean company were supplied to three million diabetic patients in 98 countries around the world. The industry insider commented, “AstraZeneca has already made multiple investment deals with Korean companies like the COVID-19 vaccine. It’s one of a very few global companies considers Korean pharmaceutical and bio industry as their partner.”
- Company
- Tecentriq can be prescribed at Big 5 hospitals
- by Eo, Yun-Ho Aug 05, 2020 06:25am
- The indication for triple negative breast cancer of the immuno-cancer drug'T-Sentric' is expanding. According to the related industry, Tecentriq 850mg used for triple-negative breast cancer (TNBC) passed the drug commitee (DC) at 20 major hospitals nationwide, including the Big 5 General Hospital, including Seoul National University Hospital, Severance Hospital, Asan Medical Center, and Seoul St. Mary's Hospital. Triple negative breast cancer among breast cancers, which has a negative response to all receptors (estrogen, progesterone, HER2), has been difficult to resolve for a long time. The anti-immune cancer drug 'Tecentriq (Atezolizumab)' with a mechanism of PD-L1 inhibition has been approved as TNBC therapeutic agent, and physicians are looking forward. Tecentriq is the only immune cancer drug that has secured TNBC indications. Tecentriq obtained approval from the MFDS on January 30 for combination therapy with Abraxane (albumin-bound Paclitaxel) in the treatment of patients with non-resectable, locally advanced or metastatic triple negative breast cancer, which is PD-L1 positive, who had not previously undergone chemotherapy at the metastatic stage. It is based on the results from the Phase III IMpassion130 study. Progression-free survival (PFS) results demonstrated a statistically significant benefit for Tecentriq in combination with nab-Paclitaxel (Abraxane) and showed that Tecentriq plus nab-Paclitaxel significantly reduced the risk of disease worsening or death (PFS) by 38% compared with nab-paclitaxel alone (median PFS=7.5 vs 5 months; hazard ratio [HR]=0.62, 95% CI: 0.49-0.78, p
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- Eisai’s lifestyle app HeLpy for living the healthier life
- by Eo, Yun-Ho Aug 05, 2020 06:25am
- Captured image of HeLpy app users logging and sharing the app use Eisai Korea reported their employees are enjoying the ‘Healthier HeLpy Life’ with the company’s personal lifestyle app ‘HeLpy’ launched in January. The employees health-conscious life started as the company decided to manage their health amid COVID-19, when the busy employees struggled to keep themselves healthy with restricted physical activity. The so-called ‘Healthier HeLpy Life’ project initiated from July 1 and had the employees to set their personal health goals on the HeLpy app and to constantly monitor their healthier lifestyle achieving the set goals. About 200 employees selected their concerning health issues, such as blood pressure, blood glucose level, drinking and smoking cessation and weight watch, and chose health goals personally recommended by the app by disease risk indicators. During the project, the employees kept a log of their changes and shared them on the community board to encourage each other. In just a month of using the HeLpy app, the employees reported their improved health indicators like blood pressure and blood sugar level through weight loss, and experiences of fixing body posture and losing pains in back and neck by regularly working out. The company anticipates the employees would continue to manage their health through the app for a while. Eisai Korea also plans to continue operating the employee health management program using the HeLpy app. Since its launch in January, HeLpy app has been downloaded for over 300,000 times and attracted 150,000 members. The app is scheduled to provide an extensive renewal update in September to enhance user experience and interface and introduce various points system to promote new membership and active use of the app.
- Company
- Indications for Keytruda·Tecentriq are actively expanding
- by Eo, Yun-Ho Aug 05, 2020 06:24am
- #Expansion of indications for immunocancer drugs continues. According to the related industry, MSD Korea recently obtained the approval for the expansion of indications of inhibitor 'Keytruda (Pembrolizumab)' in head and neck cancer, and Roche Korea's PD-L1 inhibitor 'Tecentriq (Atezolizumab)' in liver cancer. Keytruda can be prescribed for chemotherapy and combination therapy in primary treatment of metastatic or non-surgical recurrent head and neck squamous cell carcinoma and as monotherapy in primary treatment of metastatic or non-surgical recurrent head and neck squamous cell carcinoma with positive PD-L1 expression. The approval for this indication was based on KEYNOTE-048, a phase III clinical study in which Keytruda alone, anti-cancer chemotherapy and combination therapy were evaluated in comparison with a control group (Cetuximab and platinum-based chemotherapy). As a result of the study, the median overall survival (OS) of Keytruda alone and chemotherapy in patients with CPS 1 or higher was 12.3 months and 13.6 months, respectively, and significantly improved compared to 10.3 and 10.4 months in each control group. Median Progression Free Survival (PFS) values were 3.2 months and 5.0 months, respectively, in Keytruda alone and in combination therapy. The results of the study were published in Lancet. Tecentriq can be prescribed with a combination of the targeted anticancer drug 'Avastin (Bevacizumab)' as a primary therapy in patients with non-resectable hepatocellular carcinoma who have not previously received systemic treatment. The approval was based on the Phase III clinical trial of IMbrave150. The results of the IMbrave150 study were first unveiled at the European Society for Medical Oncology (ESMO) Asia Conference in November 2019, and in May of this year, the New England Journal of Medicine (NEJM). The IMbrave150 trial was conducted in patients with non-resectable hepatocellular carcinoma who had no previous systemic treatment experience. Patients who participated in the clinical trials were randomized to 2:1 in the treatment group of Tecentriq-Avastin and Sorafenib alone, and were treated until unacceptable toxicity or clinical efficacy was lost. The primary endpoints were overall survival (OS) and PFS. Studies have shown that the combination therapy of Tecentriq-Avastin reduced the risk of death by 42% compared to Sorafenib. The follow-up of 8.6 months (median value) in the group administered with Tecentriq-Avastin did not reach the median value until the data cut-off, whereas the control group was found to be 13.2 months (median value). In addition, the treatment with Tecentriq also improved the risk of disease progression and death by 41%. The PFS (median value) of the Tecentriq combination group was 6.8 months, which was 2.5 months longer than that of the control group.
