Junshi Biosciences Announces FDA Approval of Investigational New Drug Application for Anti-CD112R Monoclonal Antibody for Treatment of Advanced Solid Tumors

SHANGHAI, China, April 03, 2022 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its anti-CD112R monoclonal antibody (TAB009/JS009) for the treatment of advanced solid tumors.

TAB009/JS009 is a recombinant humanized IgG4 monoclonal antibody against human CD112R developed independently by Junshi Biosciences, for the treatment of advanced malignant tumors. CD112R, also known as PVRIG (Poliovirus receptor-related immunoglobulin domain-containing protein), is a new immune checkpoint pathway discovered by the company. Dr. Sheng Yao, Senior Vice President of the company, is one of the discoverers of this novel pathway.

CD112R is a single-pass transmembrane protein of the PVR family, mainly expressed on T cells and NK cells, and is significantly upregulated upon activation. CD112R and TIGIT share a common ligand, CD112, which is expressed on the surface of antigen-presenting cells and certain tumor cells. CD112R can inhibit the anti-tumor effect of T cells and NK cells after ligand engagement. TAB009/JS009 binds specifically to CD112R with high affinity and effectively blocks the interaction between CD112R and its ligand CD112, thereby facilitating the activation and proliferation of T cells and NK cells and enhancing the immune system’s ability to kill tumor cells. To date, no product targeting CD112R has been approved for marketing globally.

TIGIT is another immunosuppressive target of the PVR family. Its ligands include PVR and CD112, and its binding site for CD112 is different from that of CD112R. TAB009/JS009 can work synergistically with TIGIT blocking antibodies to promote T cell activation. Pre-clinical in vivo pharmacodynamics has shown that TAB009/JS009 in combination with the anti-TIGIT monoclonal antibody (TAB006/JS006) developed independently by the company exhibits significant synergistic anti-tumor effects. The investigational new drug application for TAB006/JS006 has already been approved by both China’s National Medical Products Administration (NMPA) and the U.S. FDA.

In addition, TAB009/JS009 in combination with TAB006/JS006 as well as the company’s commercialized product toripalimab, the anti-PD-1 monoclonal antibody, can further increase T-cell activation and improve the efficacy of clinical treatment. Junshi Biosciences plans to actively explore drug combinations to maximize the synergistic anti-tumor potential of its self-developed products.

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 over 50 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 monoclonal antibody for tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and has since entered Phase Ib/II trials in both China and the US. Its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA.

In the face of the pandemic, Junshi Biosciences’ response was strong and immediate, joining forces with Chinese and international scientific research institutions and enterprises to develop an arsenal of drug candidates to combat COVID-19, taking the initiative to shoulder the social responsibility of Chinese pharmaceutical companies by prioritizing and accelerating COVID-19 R&D. Among the many drug candidates is JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 and the result of the combined efforts of Junshi Biosciences, the Institute of Microbiology of the Chinese Academy of Science and Lilly. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (“EUA”) in over 15 countries and regions worldwide. Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, is in global Phase III clinical trials. The JS016 and VV116 programs are a part of the company’s continuous innovation for disease control and prevention of the global pandemic.

Junshi Biosciences has more than 2,800 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

Junshi Biosciences Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-2250 0300

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81-year-old Tibet man dies after self-immolation protest at Kirti Monastery

An 81-year-old Tibetan man has died after a self-immolation protest over Chinese rule, setting himself on fire last week at a police station in front of a major monastery in the western Chinese province of Sichuan, a source from the monastery’s branch in India told RFA late Saturday.

The burning death on March 27 of a man identified as Taphun raises to 160 the number of Tibetans confirmed to have set themselves on fire since 2009, nearly all to protest Chinese rule in the Tibetan Autonomous Region, as well as historically Tibetan areas of Sichuan and Qinghai provinces.

“On the 27th of March, around 5 o’clock in the morning, 81-year-old Taphun self-immolated in front of a police station near Kirti Monastery in a protest against the Chinese government’s oppression,” said Kanyak Tsering, a spokesman at the monastery’s branch in Dharamsala, India, home to the Tibetan government in exile and the Dalai Lama.

“He was immediately taken away by the Chinese police. Though it’s been a few days since we learned about this incident, now it is confirmed that he has passed away,” the spokesman told RFA’s Tibetan Service.

The 550-year-old Kirti Monastery lies in Ngaba (in Chinese, Aba) Tibetan Autonomous Prefecture in Sichuan Province, part of what was formerly the Amdo region of Tibet before it was absorbed by China.

“The place where Taphun self-immolated is in front of the police station that is right outside Kirti Monastery’s entrance,” said Tsering.

“March is usually a very sensitive month for Tibetans and we have often seen many Tibetans in Ngaba self-immolate in the past,” the exile Kirti spokesman noted.

“There are more restrictions and police presence around this time than usual and Tibetans are often arbitrarily interrogated by the Chinese police,” he added.

March 10 is Tibetan Uprising Day, the date in 1959 of a failed armed rebellion against Chinese rule that resulted in a violent crackdown on Tibetans that drove the Dalai Lama across the Himalayas into exile in India.

Although disclosed on April 2, the Kirti incident took place three days before the most recent known self-immolation–that of a man, known only as Tsering, who set himself ablaze in front of a Chinese police station near a Buddhist monastery in Kyegudo (in Chinese, Jiegu), in Yushul (Yushu) Tibetan Autonomous Prefecture in Qinghai. His fate and other details remain unknown.

Sporadic demonstrations challenging Beijing’s rule over what was an independent nation until China’s invasion in 1950 have continued in Tibetan-populated areas of China since widespread protests swept the region in the run-up to the 2008 Beijing Olympics.

High-technology controls on phone and online communications in Tibetan areas often prevent news of Tibetan protests and arrests from reaching the outside world, and sharing news of self-immolations outside China has led to jail sentences.

Chinese authorities maintain a tight grip on the Himalayan region, restricting Tibetans’ political activities and peaceful expression of ethnic and religious identity, and subjecting Tibetans to persecution, torture, imprisonment, and extrajudicial killings.

Translated by Tenzin Dickyi for RFA’s Tibetan Service. Written in English by Paul Eckert.

Thailand, Southern Insurgent Group To Halt Violence During Ramadan

The Thai government on Saturday hailed “significant progress” in the latest talks with the main group fighting an insurgency in Thailand’s Muslim deep south after the sides agreed to stop violence during the upcoming holy month of Ramadan.

A Thai government delegation and representatives of the main rebel group, the Barisan Revolusi Nasional (BRN), met face to face earlier this week in Malaysia in the latest round of talks after peace dialogue resumed in January after a two-year pause because of the COVID-19 pandemic.

More than 7,300 people have been killed in insurgency-related violence since 2004 when a decades-old rebellion flared up in the provinces of Narathiwat, Yala, Pattani and parts of Songkhla, a predominantly Malay-speaking Muslim area in majority Buddhist Thailand.

The BRN said in a statement that the two sides have agreed to stop violence during Ramadan, which runs from April 3 to May 14, to “create a safe and prosperous atmosphere” for the community as a process of “confidence-building” to “establish meaningful peace.”

Thailand said in a statement that the creation of an “environment conducive to peace” during Ramadan will allow people to “safely perform their religious practices” and boost public confidence in the peace dialogue.

Both sides have also agreed to established joint working groups in three areas, including the reduction of violence, public consultations and a political solution, the Thai government said.

Shadowy rebel groups have called for independence for the southern Malay-Muslim majority provinces, which were part of a sultanate called Patani and annexed by Thailand in 1909 as part of treaty with Britain.

Separatists have long complained Malay Muslims were forcibly assimilated by Thailand and accused Thai security forces of past atrocities. The Thai government has defended its operations in the area.

Talks between the Thai government and rebel groups started in 2013 although they have been disrupted frequently. The latest round of talks restarted in 2019, leading to formal peace talks facilitated by Malaysia in early 2020, but those were interrupted by the pandemic.

 

 

Source: Voice of America

How China’s Tiktok, Facebook Influencers Push Propaganda

To her 1.4 million followers on social media, Vica Li says she is a “life blogger” and “food lover” who wants to teach her fans about China so they can travel the country with ease.

“Through my lens, I will take you around China, take you into Vica’s life!” she says in a January video posted on YouTube and Facebook.

But that lens may be controlled by CGTN, the Chinese-state run TV network where she has regularly appeared in broadcasts and is listed as a digital reporter on the company’s website. While Vica Li tells followers she “created all of these channels on her own,” her Facebook account shows at least nine people manage her page.

That portfolio of accounts is just one tentacle of China’s growing influence on U.S.-owned social media platforms, an Associated Press examination has found.

As China continues to assert its economic might, it is using the global social media ecosystem to expand its already formidable influence. The country has built a network of social media personalities who parrot the government’s perspective in posts, operating in virtual lockstep as they promote China, deflect criticism of its human rights abuses and advance Beijing’s talking points on world affairs like Russia’s war against Ukraine.

Some of China’s state-affiliated reporters have posited themselves as trendy Instagram influencers or bloggers. The country has also hired firms to recruit influencers to deliver carefully crafted messages that boost its image to social media users.

And it is benefitting from a cadre of Westerners who have devoted YouTube channels and Twitter feeds to echoing pro-China narratives on everything from Beijing’s treatment of Uyghur Muslims to Olympian Eileen Gu, an American who competed for China in the most recent Winter Games.

The influencer network allows Beijing to proffer propaganda to social media users around the globe. At least 200 influencers with connections to the Chinese government or its state media are operating in 38 different languages, according to research from Miburo, a firm that tracks foreign disinformation operations.

“You can see how they’re trying to infiltrate every one of these countries,” said Miburo President Clint Watts, a former FBI agent. “If you just bombard an audience for long enough with the same narratives people will tend to believe them over time.”

Russia’s war with Ukraine is but one example.

While the invasion was being condemned as a brazen assault on democracy, Li Jingjing presented a different narrative to her 21,000 YouTube subscribers, posting videos that echoed Russian propaganda and promoted misleading claims — including that the U.S. and NATO provoked Russia’s invasion.

On YouTube, Li Jingjing says she’s a “traveler,” “storyteller” and journalist.” But she does not reveal in her segments that she’s a reporter for CGTN, articulating views that are not just her own but also familiar Chinese government talking points. Neither Vica Li nor Li Jingjing responded to questions from AP.

The AP identified dozens of similar accounts, which collectively have more than 10 million followers and subscribers. The profiles often belong to Chinese state media reporters who have transformed their Facebook, Instagram, Twitter and YouTube accounts — platforms largely blocked in China — and begun identifying as “bloggers,” “influencers” or non-descript “journalists.”

“They clearly have identified the ‘Chinese lady influencer’ is the way to go,” Watts said of China.

Foreign governments have long tried to exploit social media to stealthily influence users, including during the 2016 U.S. election.

In response, tech companies like Facebook and Twitter promised to better alert American users to foreign propaganda by labeling state-backed media accounts.

But the AP review found most of the Chinese influencer social media accounts are inconsistently labeled as state-funded media. The accounts, like those belonging to Li Jingjing and Vica Li, are often labeled on Facebook or Instagram, but aren’t flagged on YouTube or TikTok. Vica Li’s account is not labeled on Twitter. Last month, Twitter began identifying Li Jingjing’s account as Chinese state-media.

CGTN did not respond to interview requests. CGTN America, which is registered as a foreign agent with the Justice Department and has disclosed having commercial arrangements with international news organizations including the AP, CNN and Reuters, did not return messages. A lawyer who has represented CGTN America did not respond either.

A spokesman for the Chinese Embassy in Washington, Liu Pengyu, said “Chinese media and journalists carry out normal activities independently, and should not be assumed to be led or interfered by the Chinese government.”

China’s interest in social media influencers became evident in December when filings with the Justice Department revealed the Chinese Consulate in New York paid $300,000 to New Jersey firm Vippi Media to recruit influencers to post messages to Instagram and TikTok followers during the Beijing Olympics. Vipp Jaswal, Vippi Media’s CEO, declined to share with AP details about the posts.

English-speaking influencers have also cultivated a niche by promoting pro-Chinese messaging on YouTube and Twitter.

Last April, CGTN invited English speakers from around the world to join a months-long competition that would end with jobs as social media influencers in London, Nairobi, Kenya or Washington.

British video blogger Jason Lightfoot raved about the opportunity in a YouTube video and has accrued 200,000 subscribers with headlines like “The Olympics Backfired on USA — Disastrous Regret” and “Western Media Lies about China.”

The video topics are in sync with those of other pro-China bloggers like Cyrus Janssen, a U.S. citizen in Canada. During the Olympics, Janssen and Lightfoot shared identical images on the same day of Gu in posts celebrating her three-medal win and blasting the U.S.

Janssen told AP he’s never accepted money from the Chinese government. But when pressed for details about some of his partnerships with Chinese tech firms, Janssen responded only with questions about an AP’s reporter salary.

YouTubers Matthew Tye, an American, and Winston Sterzel, who is from South Africa, believe, in many cases, China is paying for content.

They were included last year on an email pitch to numerous YouTube influencers from a company that identified itself as Hong Kong Pear Technology. The email asked them to share a promotional video for China’s touristy Hainan province on their channels. Pear Technology followed up in another email with a pitch for them to post a propaganda video that asserted COVID-19 originated from North American white-tailed deer, not China.

Sterzel and Tye didn’t hear anything further after they requested the company provide evidence to support that claim.

“There’s a very easy formula to become successful,” Sterzel said in an interview. “It’s simply to praise the Chinese government, to praise China and talk about how great China is and how bad the West is.”

 

 

Source: Voice of America

Kim’s Sister Enraged by Seoul’s Preemptive Strike Comments

The influential sister of North Korean leader Kim Jong Un called the South Korean defense minister a “scum-like guy” for talking about preemptive strikes on the North, warning Sunday that the South may face “a serious threat.”

 

Kim Yo Jong’s statement came amid heightened tensions between the rival Koreas over the North’s spate of weapons tests this year, including its first intercontinental ballistic missile launch in more than four years. Some experts say her statement could signal that North Korea will conduct more significant weapons tests soon and take a hardline stance on South Korea.

 

The ICBM test March 24 that broke North Korea’s four-year moratorium on big weapons tests was an embarrassment to South Korea’s liberal President Moon Jae-in, who has pushed hard to achieve greater reconciliation between the countries and find a peaceful resolution to the North Korean nuclear crisis.

 

During a visit to the country’s strategic missile command Friday, South Korean Defense Minister Suh Wook said that South Korea has the ability and readiness to launch precision strikes on North Korea if it detects the North intends to fire missiles at South Korea. Seoul has long maintained such a preemptive attack strategy to cope with North Korea’s growing missile and nuclear threats, but it was highly unusual for a senior Seoul official under the Moon administration to publicly discuss it.

 

On Sunday, Kim’s sister, Kim Yo Jong, issued blistering rhetoric directed at Suh and threats toward Seoul.

 

“The senseless and scum-like guy dare mention a ‘preemptive strike’ at a nuclear weapons state,” Kim Yo Jong said in a statement carried by state media. “South Korea may face a serious threat owing to the reckless remarks made by its defense minister.”

 

“South Korea should discipline itself if it wants to stave off disaster,” she said.

 

Kim Yo Jong, a senior official in the North’s ruling Workers’ Party, is in charge of relations with Seoul and Washington. South Korea’s spy service says she is the North’s No. 2 official behind her brother.

 

Pak Jong Chon, a secretary in the Workers’ Party’s central committee, separately warned that “any slight misjudgment and ill statement rattling the other party under the present situation” may trigger “a dangerous conflict and a full-blown war.”

 

Pak said North Korea will “mercilessly direct military force into destroying major targets in Seoul and the South Korean army” if South Korea preemptively attacks North Korea.

 

Relations between the Koreas briefly flourished in 2018 after North Korea abruptly reached out to South Korea and the United States and expressed its willingness to put its nuclear program on the bargaining table. At the time, Kim Yo Jong visited South Korea to attend the opening ceremony of the Winter Olympics and conveyed her brother’s invitation for Moon to visit the North. Kim Jong Un and Moon eventually met three times in 2018.

 

But North Korea turned a colder shoulder on Moon and cut off ties with South Korea after its broader nuclear diplomacy with the United States collapsed in 2019 due to disputes over U.S.-led economic sanctions on the North.

 

“Kim Yo Jong’s remarks foreshadow another significant military test,” said Leif-Eric Easley, a professor at Ewha University in Seoul. “Similar to how Moscow and Beijing try to gaslight the world that Russia’s invasion of Ukraine is somehow the fault of NATO, Pyongyang will blame its nuclear and missile advancements on the U.S.-South Korea alliance.”

 

Analyst Cheong Seong-Chang at the private Sejong Institute in South Korea said that the back-to-back North Korean statements indicate that it will take hardline steps toward South Korea. He said that Pyongyang is sensitive to Seoul’s preemptive attack capability because it lacks military assets and capability to detect South Korean strikes in advance.

 

But Cheong worried that Seoul’s public comments on preemptive strikes would result in strengthening the voices of hardline officials in Pyongyang and raising tensions between the Koreas.

 

Moon’s single five-year term ends in May, when he will be replaced by conservative Yoon Suk Yeol, who openly discussed the preemptive attack strategy on North Korea during his campaign. His liberal rivals criticized him for unnecessarily provoking North Korea, but Yoon said he would pursue a principled approach on Pyongyang.

 

The United States has urged North Korea to return to talks without preconditions, but the North has rejected such an overture saying the U.S. must first drop its hostility toward it. Kim Jong Un has repeatedly vowed to expand his nuclear arsenal as a diplomatic stalemate with Washington continues.

 

Some experts say the North’s recent missile tests were meant to perfect its weapons technology, boost its leverage in future negotiations with the U.S. and secure stronger internal loyalty. They say North Korea could soon conduct another ICBM launch, a launch of a satellite-carrying rocket or a test of a nuclear device in coming weeks.

 

 

Source: Voice of America

P44m in TUPAD wages disbursed in Ilocos region in Q1

The labor department disbursed a total of Php44 million in wages in Ilocos Region under its flagship employment program.

 

A total of 12,386 displaced and disadvantaged workers in the informal sector benefitted from the department’s Tulong Panghanapbuhay sa Ating Disadvantaged/ Displaced Workers (TUPAD) program in the January to March period.

 

“TUPAD has become a very important financial safety net for many of our informal workers. We are grateful to have been part of a program that has recreated jobs and provided a respite for those most affected by the pandemic,” Labor Secretary Silvestre Bello III said.

 

The workers rendered various community work that include cleaning and disinfection, and greening and tree-planting activities. These projects were undertaken in the beneficiaries’ respective barangays for a period of 10 to 15 days. They received salaries that ranged between Php3,400 to P5,100 per person.

 

Of the total beneficiaries, 1,198 were from Ilocos Norte; 1,276 from Ilocos Sur; 944 from La Union; 951 from Pangasinan’s Districts 1-2; 4,925 from Districts 3-4 of Pangasinan; and 3,092 from Pangasinan’s Districts 5-6.

 

DOLE RO1 Regional Director Atty. Evelyn Ramos said DOLE continues to implement the TUPAD as it has been exempted from the election ban by the Commission on Election.

 

“Secretary Bello underscored that these DOLE programs are demand-driven and have continuously served the marginalized, vulnerable, and under-privileged beneficiaries/ workers for decades, hence their exemption from the ban,” Ramos said.

 

She added that the regional office will continue to implement TUPAD in the coming months, but safety measures are in place to ensure the program remains non-partisan.

 

Source: Republic of Philippines Department Of Foreign Affairs