FDA gives Green Valley the go-ahead for its Alzheimer’s trial
The Food and Drug Administration has approved a Phase 3 clinical trial for an investigational Alzheimer’s drug from Shanghai Green Valley Pharmaceutical.
Green Valley won conditional approval for its seaweed-derived drug, Oligomannate, in November, which the company said improved cognitive function in patients with mild to moderate disease. In that study, benefits were seen in patients as early as week four and persisted throughout the remainder of the 36 weeks of the trial, the firm said.
In a statement, Green Valley said the trial in the United States would be part of a global study across North America, Europe, and Asia. The size of the U.S. trial was not disclosed, but trials worldwide are expected to be completed by 2024.
Green Valley won conditional approval for its seaweed-derived drug, Oligomannate, in November, which the company said improved cognitive function in patients with mild to moderate disease. In that study, benefits were seen in patients as early as week four and persisted throughout the remainder of the 36 weeks of the trial, the firm said.
In a statement, Green Valley said the trial in the United States would be part of a global study across North America, Europe, and Asia. The size of the U.S. trial was not disclosed, but trials worldwide are expected to be completed by 2024.
Is America’s antibiotics supply at risk because of China?
China is responsible for the global supply of 80% of all antibiotics, humanity’s primary weapon against bacterial infection. The United States, meantime, had more than 30 antibiotic manufacturing facilities in the late 1980s. Today, the world’s richest nation does not have a single large-scale producer of penicillin or other antibiotics.
Experts are increasingly worried about U.S. vulnerability to China’s near-lock on medication production, including the antibiotic supply. And in a new special report from The Wire China, published in STAT, they make clear that action is needed now.
“It’s enormously worrisome that the United States has come to depend so heavily on medical products manufactured, in whole or in part, from countries like China,” Margaret Hamburg, a former FDA commissioner said. “This has led to terrible capacity gaps to make antibiotics and other drugs that are vital to U.S. health, and in fact crucial to our national security.”
Read more.
Experts are increasingly worried about U.S. vulnerability to China’s near-lock on medication production, including the antibiotic supply. And in a new special report from The Wire China, published in STAT, they make clear that action is needed now.
“It’s enormously worrisome that the United States has come to depend so heavily on medical products manufactured, in whole or in part, from countries like China,” Margaret Hamburg, a former FDA commissioner said. “This has led to terrible capacity gaps to make antibiotics and other drugs that are vital to U.S. health, and in fact crucial to our national security.”
Read more.
Fosun Pharma’s Covid-19 test kit approved by FDA
Shanghai-based Fosun Pharma’s Covid-19 detection kit received an emergency use authorization from the FDA, joining Chinese genomics company BGI – which received its EUA in March – on the list of approved test kits.
Chinese manufacturers have been ramping up their production and shipment of test kits to other countries fighting the pandemic, but have also come under fire from a number of European countries for the products’ poor accuracy in detecting the virus.
The test kits in question are typically testing for antibodies against Covid-19, which is different from the test kits from Fosun Pharma and BGI, which detect the nucleic acid of the virus.
Fosun Pharma’s test kit has also been accepted by China’s National Medical Products Administration and regulators in the European Union. In March, the company partnered with German drug developer BioNTech to develop a mRNA vaccine for Covid-19.
Chinese manufacturers have been ramping up their production and shipment of test kits to other countries fighting the pandemic, but have also come under fire from a number of European countries for the products’ poor accuracy in detecting the virus.
The test kits in question are typically testing for antibodies against Covid-19, which is different from the test kits from Fosun Pharma and BGI, which detect the nucleic acid of the virus.
Fosun Pharma’s test kit has also been accepted by China’s National Medical Products Administration and regulators in the European Union. In March, the company partnered with German drug developer BioNTech to develop a mRNA vaccine for Covid-19.
Sinovac gets loan to build production site, eyes 100 million vaccines per year
Sinovac Biotech said it took out a loan to build a new manufacturing facility to develop its experimental coronavirus vaccine, the Beijing-based biotech told Reuters.
If proven effective, Sinovac is aiming to manufacture up to 100 million doses of the vaccines a year. If it doesn’t work, the company will use the production site for its other products, including vaccines for hepatitis A and B, and several influenza strains.
Two weeks ago, China’s NMPA granted approval for Sinovac to start clinical trials for its Covid-19 vaccine candidate. Two other companies — Sinopharm and CanSino Biologics — are testing Covid-19 vaccines.
According to Xinhua, Sinopharm’s vaccine is now in a Phase 2 study, as is a vaccine candidate from CanSino. China’s public health officials have said they are aiming to have a Covid-19 vaccine ready for public use by early next year.
If proven effective, Sinovac is aiming to manufacture up to 100 million doses of the vaccines a year. If it doesn’t work, the company will use the production site for its other products, including vaccines for hepatitis A and B, and several influenza strains.
Two weeks ago, China’s NMPA granted approval for Sinovac to start clinical trials for its Covid-19 vaccine candidate. Two other companies — Sinopharm and CanSino Biologics — are testing Covid-19 vaccines.
According to Xinhua, Sinopharm’s vaccine is now in a Phase 2 study, as is a vaccine candidate from CanSino. China’s public health officials have said they are aiming to have a Covid-19 vaccine ready for public use by early next year.
Chinese regulators reviewing cancer therapies from Suzhou pharmas
China’s NMPA accepted new drug applications from a pair of Suzhou-based drug developers: CStone Pharma and Innovent Biologics.
First up, CStone filed its first ever NDA for avapritinib — in-licensed from Blueprint Medicines in 2018 — to treat advanced forms of gastrointestinal stromal tumors, or GIST. The company hopes the drug will be its first commercialized product.
Avapritinib is an inhibitor of KIT and PDGFRA, proteins that are mutated in GIST that lead to the development of tumors. About 90% of GIST patients have these mutations and most respond poorly to chemotherapy and radiotherapy. The drug was approved by the FDA in January and is marketed as Ayvakit in the U.S.
Chinese regulators are also reviewing Innovent’s sintilimab, or Tyvyt, for treating non-squamous non-small cell lung cancer when combined with Eli Lilly’s chemotherapy Alimta. Tyvyt, an anti-PD-1 cancer therapy, is currently only indicated for relapsed or refractory classical Hodgkin’s lymphoma in China.
First up, CStone filed its first ever NDA for avapritinib — in-licensed from Blueprint Medicines in 2018 — to treat advanced forms of gastrointestinal stromal tumors, or GIST. The company hopes the drug will be its first commercialized product.
Avapritinib is an inhibitor of KIT and PDGFRA, proteins that are mutated in GIST that lead to the development of tumors. About 90% of GIST patients have these mutations and most respond poorly to chemotherapy and radiotherapy. The drug was approved by the FDA in January and is marketed as Ayvakit in the U.S.
Chinese regulators are also reviewing Innovent’s sintilimab, or Tyvyt, for treating non-squamous non-small cell lung cancer when combined with Eli Lilly’s chemotherapy Alimta. Tyvyt, an anti-PD-1 cancer therapy, is currently only indicated for relapsed or refractory classical Hodgkin’s lymphoma in China.
Hansoh Pharma, NiKang Therapeutics pair up for novel antiviral treatments
Jiangsu’s Hansoh Pharma and Delaware-based biotech startup NiKang Therapeutics are partnering to develop an experimental therapy that can treat viral infections.
NKT-1992 is a small molecule that can potentially inhibit a highly conserved enzymatic domain essential for viral transcription and replication.
Under the terms of the deal, NiKang will receive an upfront collaboration fee and potentially additional payments of more than $100 million from Hansoh, upon meeting certain regulatory and commercial milestones, with royalties based on net sales. Hansoh will have development and commercialization rights in China.
NKT-1992 is a small molecule that can potentially inhibit a highly conserved enzymatic domain essential for viral transcription and replication.
Under the terms of the deal, NiKang will receive an upfront collaboration fee and potentially additional payments of more than $100 million from Hansoh, upon meeting certain regulatory and commercial milestones, with royalties based on net sales. Hansoh will have development and commercialization rights in China.
China’s largest CRO files for IPO on Hong Kong Exchange
Hangzhou Tigermed Consulting is seeking to list on the Hong Kong Stock Exchange. According to the filing on Friday, the clinical-stage contract research organization will use the capital raised to expand operational capacity and capabilities, fund potential M&A activity, and repay certain debts.
Tigermed is China’s largest CRO by revenue and number of clinical trials, according to Frost & Sullivan. In 2019, it held a market share of 8.4% in the CRO sector. Last July, the company inked a strategic cooperation agreement with AstraZeneca to partner on R&D projects in China.
Tigermed has been trading its shares in mainland China on the Shenzhen stock exchange since 2012.
Tigermed is China’s largest CRO by revenue and number of clinical trials, according to Frost & Sullivan. In 2019, it held a market share of 8.4% in the CRO sector. Last July, the company inked a strategic cooperation agreement with AstraZeneca to partner on R&D projects in China.
Tigermed has been trading its shares in mainland China on the Shenzhen stock exchange since 2012.
More reads:
- Cancer screening startup New Horizon Health raises $20 million in Series D (China Money Network)
Chinese scientists design drugs to target SARS-CoV2’s main protease (Science)
Akeso banks on pharma tie-up in race with rivals amid record-setting Hong Kong IPO (South China Morning Post)
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