Authorities in Xi’an, a city of 13 million that has imposed China’s strictest Covid-19 lockdown since Wuhan two years ago, have fired medical workers and promised an official apology and compensation after a report of a pregnant woman who miscarried after she was made to wait outside a hospital for two hours went viral before being censored. Accounts of distress, including a heart attack death and severe food shortages, have emerged since the ancient central Chinese city known for the Terracotta Warriors confined residents to their homes for two weeks under Beijing’s “Zero-Covid” regimen of mass testing, extensive quarantines and summary lockdowns.
Taiwan showcases new warships in display of deterrence to China
Taiwan has showcased some of its indigenous-built warships at an event designed to send a message of deterrence to China, local officials and analysts said.
Over the weekend, the Taiwanese Ministry of Defense held a naval exercise off the coast of Keelung in northeastern Taiwan, part of three days of multi-disciplinary drills at different locations to demonstrate the military’s combat readiness, the ministry’s news service said.
“We want the People’s Liberation Army (PLA) [of China] to think twice before it acts,” Col. Sun Li-fang from the Taiwanese Army Command’s Political Warfare Bureau told media at one of the drills.
The Defense Ministry said two Taiwanese-designed corvettes, including the newly commissioned Ta Chiang, took part in the naval exercise on Friday. They were seen conducting tracking and firing simulations in rough seas conditions.
The 500-ton corvettes, dubbed “aircraft carrier killers,” were built by the Lung Teh Shipbuiding Company in Yilan County. They are armed with Sea Sword II medium-range air defense missiles, anti-ship missiles, 76 mm cannons and close-in weapons systems.
Shu Hsiao-huang, an analyst at the Institute for National Defense and Security Research, was quoted by the state-run Central News Agency (CNA) as describing the ships as “mobile, stealthy, fast, and powerful.”
The corvettes can be fitted with missile launchers if needed, but Shu was quoted as said that at the meantime, they are well suited for “gray zone” patrols, including in the South China Sea. Gray zone activities are generally not explicit acts of war but harmful to the security of a nation.
In 2011, the Taiwanese parliament approved a budget of over US$850 million to build up to 12 new warships to deal with new maritime challenges mainly from China. With around 360 ships at the end of 2020, China has the largest navy in the world, according to a U.S. Defense Department report.
Beijing regards Taiwan, a self-governing island located about 100 miles (160 kilometers) off the mainland, as part of China. It has stepped up military drills in the island’s vicinity. Taiwan views itself as a sovereign state. It is also a claimant in the South China Sea, along with Brunei, China, Malaysia, the Philippines and Vietnam.
Minelaying systems
At the naval drill, the Taiwanese navy also showcased for the first time its home-designed, automatic minelaying system used aboard new Min Jiang-class vessels. These mine-laying vessels are not large but have hi-tech navigation capabilities that said to facilitate fast and accurate mine-laying operations in enemy waters.
The island’s navy has four indigenous-built rapid minelaying ships – two of them delivered only last month.
Last weekend’s exercise was conducted using a worst-case scenario – a PLA attack – explained Qi Leyi, a Taipei-based military analyst and commentator for RFA Mandarin.
“The new fast minelaying boats can greatly prevent the enemy’s beach-landing operations and become a reliable combat force for Taiwan’s multi-domain deterrence,” Qi said.
“Taiwan cannot compare with China in terms of the number of warships, so it’s got to look for a better technology,” he added.
Mine warfare has become increasingly important in maritime conflicts, as sea mines are among the most dangerous naval weapons. The PLA Navy last month conducted a large-scale bomb dropping and sea mine-laying exercise on islands in the South China Sea.
China conducts frequent military drills in disputed waters, but it’s unusual for the PLA to deploy warplanes to drop bombs and lay mines in a live-fire exercise.
Beijing steps up pressure on Hong Kong over COVID-19 party scandal, Cathay Pacific
Beijing has asked Hong Kong’s leader to “take swift action” against officials embroiled in a scandal around a birthday party at the center of a large cluster of COVID-19 cases, local media reported on Monday.
The ruling Chinese Communist Party (CCP) is stepping up pressure on the administration of chief executive Carrie Lam, warning that any delay could hurt the government’s credibility, the South China Morning Post (SCMP) reported, citing government advisers as saying that suspension, demotion, pay cuts or even dismissal are all possibilities.
Meanwhile, a CCP-backed Hong Kong newspaper on Monday called for criminal prosecution and swift retribution for senior executives at the city’s flagship airline after its employees were fired for breaking quarantine rules.
“Loopholes need to be plugged, and the offenders need to be severely punished to prevent others from doing the same,” the Ta Kung Pao said in an editorial after the airline was identified by an anti-epidemic taskforce from Beijing as a weak point in Hong Kong’s COVID-19 defenses.
“As a major [Hong Kong] company, Cathay Pacific must fulfill its social responsibilities in the fight against COVID-19, not least because it received nearly H.K.$30 billion in government funding during the early stages of the pandemic,” the article said, blaming Cathay for involvement in three out of five waves of coronavirus infections in Hong Kong.
“The facts have proved that Cathay’s repeated negligence has led to deaths in Hong Kong,” it said.
Lam has ordered an inquiry into the behavior of 13 senior government officials who attended the Jan. 3 birthday party of National People’s Congress (NPC) delegate Witman Hung, after which two party guests tested positive for COVID-19.
Photos of the party showed Hung and many of his guests warbling into karaoke microphones into the early hours with no masks on at a bash that was attended by dozens of high-ranking establishment figures.
“I have instructed all officials being subject to quarantine that they should not continue to discharge their duties and that they are required to take their own vacation leave for quarantine,” she said on Jan. 8.
Also at the party were 19 members of Hong Kong’s new “patriots-only” Legislative Council (LegCO) who have so far tested negative.
All party guests and hundreds of their close contacts have now been sent to compulsory government quarantine facilities as the city scrambles to contain a fresh wave of COVID-19 infections.
Senior officials who attended included Home Affairs Secretary Casper Tsui, Director of Immigration Au Ka-wang, police commissioner Raymond Siu and the head of the city’s Independent Commission against Corruption, Simon Peh, all of whom have made public apologies along with Witnam Hung.
Au has already paid a fine last year for attending a dinner in a luxury private club in a breach of a COVID-19-related ban on public gatherings of more than four people.
Translated and edited by Luisetta Mudie.
Junshi Biosciences and Coherus Expand Immuno-Oncology Collaboration to Include TIGIT-Targeted Antibody
- Junshi Biosciences and Coherus plan to evaluate the toripalimab + JS006 combination
in clinical trials in multiple tumor types - Combinations of PD-1 + TIGIT inhibitors have potential to expand checkpoint inhibitor utilization
to new tumors and lines of therapy
SHANGHAI, China, and REDWOOD CITY, Calif., Jan. 10, 2022 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”) today announced that Coherus has initiated the process to exercise its option to license JS006, Junshi Biosciences’ TIGIT-targeted antibody, in the United States and Canada, expanding the companies’ 2021 immuno-oncology collaboration agreement. Coherus will pay Junshi Biosciences $35 million upfront, up to $255 million in development regulatory and sales milestones, and an 18% royalty on net product revenue, subject to terms and conditions agreed between the parties. Closing of the transaction is expected to follow receipt of any applicable regulatory clearances. Antibodies blocking TIGIT (T cell immunoglobulin and ITIM domain) have shown potential for synergistic anti-tumor activity in combination with PD-1/PD-L1 inhibitors. In pre-clinical studies, JS006 has demonstrated excellent binding affinity and strong inhibition of the TIGIT pathway. Investigational new drug (IND) applications allowing clinical development of JS006 have been approved in Chinese Mainland and in the United States. A dose escalation, dose expansion clinical trial (NCT05061628) evaluating the safety, tolerability and pharmacokinetic properties of JS006 as monotherapy and in combination with PD-1 inhibitor toripalimab in patients with advanced solid tumors is ongoing.
“We are excited to extend our productive immuno-oncology collaboration with Coherus to include our anti-TIGIT monoclonal antibody JS006, after achieving several key milestones on toripalimab,” said Dr. Ning Li, CEO of Junshi Biosciences. “Following our ‘In China, For Global’ corporate strategy, we are actively conducting global clinical R&D programs in China, the U.S., Southeast Asia and European countries. We are grateful for the joint effort from our pre-clinical as well as clinical teams at the company’s innovation centers in China and the U.S. We believe the collaboration with Coherus will strengthen the development and commercialization of our products in the U.S. and Canada.”
“Since 2012, Junshi Biosciences has built a rich pipeline with complementary products in the area of immuno-oncology, which enable us to explore combination therapy of I-O drugs and combination of immunotherapy with other modalities, including traditional chemotherapy, radiotherapy, angiogenesis inhibitors and cytokine drugs, to provide patients with better treatment options,” said Dr. Sheng Yao, Senior Vice President of Junshi Biosciences. “The combination of anti-TIGIT and anti-PD-1 is quite promising with a potential to not only increase patients’ response to I-O therapy, but also expand the beneficial patient population. We look forward to working together with Coherus to quickly advance the combination therapy of JS006 with toripalimab across multiple tumor types.”
“TIGIT is a leading-edge immuno-oncology target with significant therapeutic potential across multiple major tumor types. The exercise of the option for JS006 marks the emergence of Coherus as an immuno-oncology development company with a rich clinical and preclinical pipeline of product candidates to drive long-term growth,” said Denny Lanfear, CEO of Coherus. “We are making rapid progress on our objective to become a leading immuno-oncology company, and the development of toripalimab combinations with therapeutics addressing novel targets such as TIGIT will allow us to access future growing markets. While toripalimab + JS006 is the first novel combination in our pipeline, our internal analytic, protein science and bioinformatics capabilities have generated additional toripalimab combination candidates. The first of these proprietary product candidates is expected to enter human clinical trials in 2023.”
“Blockade of the TIGIT pathway may be a crucial underlying mechanism for overcoming resistance to checkpoint inhibition. We believe the dual immuno-therapy approach of TIGIT with PD-1 could enhance PD-1 efficacy and create a new standard-of-care for multiple tumor types,” said Theresa LaVallee, Ph.D., Chief Development Officer at Coherus. “We recently reported that our PD-1 inhibitor, toripalimab, in combination with chemotherapy, extends both progression free survival and overall survival in patients with advanced non-small cell lung cancer. We look forward to working with our Junshi Biosciences colleagues to build upon this efficacy signal and to evaluate the potential of the JS006 and toripalimab combination to bring new, more efficacious immuno-oncology treatments forward for patients.”
About JS006
JS006 is a recombinant humanized IgG4κ monoclonal antibody specifically against human TIGIT, developed independently by Junshi Biosciences. Including back-up candidates, the JS006 program encompasses molecules with silent and active Fc functions. According to the results of preclinical studies, JS006 can specifically block the TIGIT-PVR pathway. Expressed by T cells and NK cells, TIGIT can be engaged and activated by PVR family ligands highly expressed on tumor cells and suppressive immune cells to directly inhibit the killing effect of T cells and NK cells directed at tumor cells. A number of pre-clinical and clinical studies have showed that activation of the TIGIT pathway could be a crucial underlying mechanism for the resistance to PD-1 blockade therapy. Combination of TIGIT and PD-1/PD-L1 antibodies showed a synergistic potential to enhance antitumor response to overcome anti-PD-1 resistance and broaden the cancer patient population that can benefit from immunotherapy.
In early 2021, JS006 was approved for clinical trials in both China and the United States. In the same year, Junshi Biosciences commenced a phase I trial to evaluate the safety and tolerability of JS006 as monotherapy and in combination with toripalimab in patients with advanced tumors who have failed standard therapies. Junshi Biosciences and Coherus are planning late-stage clinical development of JS006 in combination with toripalimab in North America.
About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promote the immune system’s ability to attack and kill tumor cells.
More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China, the United States, Southeast Asia, and European countries. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.
In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are 4 approved indications for toripalimab in China:
- unresectable or metastatic melanoma after failure of standard systemic therapy;
- recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy;
- locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
- in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC.
The first three indications have been included in the National Reimbursement Drug List (NRDL) (2021 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for melanoma and NPC.
In addition, two supplemental New Drug Applications (NDAs) for toripalimab are currently under review by the National Medical Products Administration (NMPA) in China:
- in combination with chemotherapy as the first-line treatment of patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC).
- in combination with chemotherapy as the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) with no EGFR or ALK sensitizing mutations.
In the United States, the FDA has granted priority review for the toripalimab biologics license application (BLA) for the treatment of recurrent or metastatic NPC, an aggressive head and neck tumor which has no FDA-approved immuno-oncology treatment options. The FDA has assigned a Prescription Drug User Fee Act target action date for April 2022 for the toripalimab BLA. The FDA granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC in 2021 as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC in 2020. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designation for the treatment of esophageal cancer, NPC, mucosal melanoma and soft tissue sarcoma. In 2021, Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Junshi Biosciences and Coherus plan to file additional toripalimab BLAs with the FDA over the next three years for multiple other cancer types.
About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising 45 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology of Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou,
About Coherus BioSciences
Coherus is a commercial stage biopharmaceutical company building a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. In 2021, Coherus in-licensed toripalimab, an anti-PD-1 antibody, in the United States and Canada. A biologics license application for toripalimab for the treatment of metastatic or recurrent nasopharyngeal carcinoma is currently under priority review by the FDA, with a target action date of April 2022. Toripalimab is also being evaluated in pivotal clinical trials for the treatment of cancers of the lung, breast, liver, skin, kidney, stomach, esophagus, and bladder.
Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta® in the United States, and expects to launch the FDA-approved Humira® biosimilar YUSIMRY™ (adalimumab-aqvh) in the United States in 2023. The FDA is currently reviewing the biologics license application for CHS-201, a biosimilar of Lucentis® (ranibizumab), with a target action date of August 2022. Coherus is also developing CHS-305, a biosimilar of Avastin® (bevacizumab).
Junshi Biosciences Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-2250 0300
Solebury Trout
Bob Ai
bai@gobyglobal.com
+ 1 646-389-6658
PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800
Coherus Contact Information
Investors:
McDavid Stilwell
Chief Financial Officer
Coherus BioSciences, Inc.
IR@coherus.com
Media:
Cheston Turbyfill
Coherus BioSciences, Inc.
IR@coherus.com
Kelli Perkins
Red House
kelli@redhousecomms.com
Myanmar military court sentences Aung San Suu Kyi to another 4 years in jail
A military court sentenced deposed Myanmar leader Aung San Suu Kyi to four years in prison Monday for the illegal possession of walkie-talkies and breaking Covid-19 rules, raising to six years the jail time imposed on her in closed-door proceedings, sources familiar with the trial said.
Nearly a year after she was overthrown and arrested by the army, the 76-year-old Aung San Suu Kyi got two years for violating export-import laws and one year for violating the communications law for the walkie-talkies, and two years for violating the natural disaster management law.
Monday’s sentences—which for the walkie-talkies will be served concurrently—are the latest of a dozen charges that could bring combined maximum sentences of more than 100 years, sources close to the court told RFA’s Myanmar Service.
On Dec. 6 Aung San Suu Kyi and President Win Myint received two years for incitement against the military and two years for violating coronavirus restrictions, which the junta chief reduced to two years of house arrest.
The former State Counselor’s lawyers have been barred since October by Myanmar’s military rulers from releasing information or speaking publicly about the two cases being tried.
She has rejected all allegations, which her supporters, rights groups and foreign governments have condemned as political.
“The Myanmar junta’s courtroom circus of secret proceedings on bogus charges is all about steadily piling up more convictions against Aung San Suu Kyi so that she will remain in prison indefinitely.” said Phil Robertson, deputy Asia director at Human Rights Watch.
The fear of her continued political power explains “the junta’s willingness to appear as global laughingstocks as they secure convictions in a kangaroo court on the flimsiest, politically motivated charges.” he said in a statement from Bangkok.
“The Myanmar military junta is running roughshod over the human rights of everyone, ranging from Suu Kyi and other elected officials of the previous government to the CDM [Civil Disobedience Movement] activists on the street,” added Robertson.
According to the Association Assistance for Political Prisoners (AAPP), the military regime has handed out 577 sentences among more than 8,500 civilians arrested or detained since the Feb. 1 coup that deposed Aung San Suu Kyi and her elected government. The junta has killed 1,459 civilians, the Bangkok-based group says.
Reported by RFA’s Myanmar Service. Written in English by Paul Eckert.
General Fusion achieves critical technology milestone for practical fusion power
Successful performance of plasma compression prototype confirms path to commercialization
General Fusion’s plasma compression prototype
General Fusion has successfully achieved several aggressive performance goals on its prototype compression system, demonstrating a critical element of the company’s Magnetized Target Fusion technology.
VANCOUVER, British Columbia, Jan. 10, 2022 (GLOBE NEWSWIRE) — General Fusion announced today it has successfully achieved several aggressive performance goals of a prototype system for its Fusion Demonstration Plant (FDP). The company’s plasma compression prototype, located at its Vancouver, Canada laboratory, is being used to demonstrate a critical element of its proprietary Magnetized Target Fusion (MTF) technology. This important milestone marks another significant step toward General Fusion’s goal of creating practical and commercially viable fusion power.
Commissioned in early 2021, the prototype machine drives a forceful, but precisely shaped, symmetric collapse of a large liquid vortex cavity in tens of milliseconds. The forces involved in the full-scale FDP compression system will be immense, pushing the limits of material science, fluid dynamics, and mechanical design. Achieving this milestone with the prototype significantly reduces engineering and technical risks for General Fusion’s FDP. It will use a collapsing liquid metal cavity to heat and compress plasma fuel to fusion conditions at 100 million degrees Celsius.
The idea of using a collapsing liquid metal cavity to create fusion has been around for decades, but General Fusion has been able to bring new enabling technologies such as high-speed digital control systems, additive manufacturing, and advanced composite materials to make this concept viable and to de-risk its implementation in the FDP. Driving a rapid, smooth, and spherically shaped collapse of a cavity created inside a rotating liquid has been a difficult engineering challenge that General Fusion has now demonstrated in this prototype machine. It is the pathfinder for a larger prototype being built in 2022 to validate further refinements to various engineering aspects of this technology.
“Net energy production is essential, but not really the ultimate goal of commercializing fusion energy, which is building economical, carbon-free fusion power plants,” said Christofer Mowry, CEO, General Fusion. “Our unique technology, two decades in the making, solves the long-standing challenges of building practical fusion power plants for the world’s energy markets struggling to move away from fossil fuels. The successful performance of this important prototype validates we are on the path to success.”
General Fusion’s unique MTF technology overcomes several key challenges of creating practical fusion energy. MTF will economically create fusion conditions, efficiently convert fusion energy into carbon-free electricity, protect the fusion machine from burning fusion plasma, and produce enough fusion fuel for its own use. General Fusion’s prototype compression system validates one of the most critical parts of its MTF technology because a mechanically collapsed liquid cavity is a cornerstone for MTF overcoming all these challenges.
About General Fusion
General Fusion is pursuing the fastest and most practical path to commercial fusion energy and is based in Vancouver, Canada, with locations in London, U.K., and Oak Ridge, Tennessee, U.S.A. The company was established in 2002 and is funded by a global syndicate of leading energy venture capital firms, industry leaders, and technology pioneers. Learn more at www.generalfusion.com.
General Fusion Media Relations
media@generalfusion.com
+1-866-904-0995
Follow General Fusion
linkedin.com/company/general-
youtube.com/c/GeneralFusionInc
A photo accompanying this announcement is available at https://www.globenewswire.com/