Day: December 25, 2022

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Boat with ‘dehydrated and exhausted’ Rohingya refugees lands in Indonesia

Dozens of “dehydrated and exhausted” Rohingya refugees – all males – landed on the coast of Aceh Besar regency in Indonesia on Christmas Sunday after being at sea for about a month, local officials said.

These 57 men were not part of a group of close to 200 Rohingya refugees and Bangladeshi migrants who were stranded on another boat believed to be drifting in waters north of Aceh province, according to an Indonesian NGO. As many as 20 people aboard the other boat have reportedly died at sea.   

The FB Tarikul Islam 2, the boat carrying the 57 men, sprung a leak and was taking on sea water, and its engine had broken down, Aceh provincial police spokesman Winardy said. The wooden boat came ashore at Indra Patra beach in Ladong, a village in Aceh Besar.

“They were forced to land and rest in Ladong because the boat’s hull was leaking and they ran out of food,” Winardy told BenarNews, an online news service affiliated with Radio Free Asia.

“Generally, they were dehydrated and exhausted,” he said.

Every year, hundreds of Rohingya undertake perilous crossings as they journey southward across the Bay of Bengal and the Andaman Sea in fleeing sprawling refugee camps along Bangladesh’s border with Myanmar or their home state of Rakhine in Myanmar, where members of the stateless minority are persecuted.

The U.N. refugee agency UNHCR earlier this month said it had recorded a six-fold increase in Rohingya undertaking such dangerous and illicit sea journeys this year, compared with 2021.

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Police officers watch a group of ethnic Rohingya people after they landed in a wooden boat at Indra Patra beach in Ladong village, Aceh province, Indonesia, Dec. 25, 2022. [Rahmat Mirza/AP Photo]

“They look very weak from hunger and dehydration. Some of them are sick after a long and severe voyage at sea,” the Associated Press quoted Rolly Yuiza away, the local police chief, as saying in referring to the people who arrived in Aceh Besar on Sunday morning.  

Winardy, the spokesman for provincial police, said four of the men on the boat were sick from dehydration.

The secretary for the regency’s administration, Sulaimi, said there were no women or children aboard the boat that drifted ashore in this corner of Aceh, a province at the northwestern tip of Sumatra island.

“Based on the information received, the Rohingya immigrants have been drifting at sea for about a month,” Sulaimi said.

Telmaizul Syatri, who heads the immigration office in Aceh, said the refugees would be temporarily housed at a local government facility, Agence France-Presse quoted him as saying.

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Indonesian policemen stand guard near a boat after at least 57 Rohingya refugees disembarked from it on Indra Patra beach in Ladong, a village in Aceh Besar regency, Aceh province, Dec. 25, 2022. [Photo courtesy of Aceh Provincial Police]

Meanwhile, the head of the Aceh branch of the Indonesian human rights group KontraS, Azharul Husna, said the group was not part of a group of 190 Rohingya refugees and Bangladeshi migrants known to be stranded at sea in recent weeks.

“This was a different boat. This boat sailed from Cox’s Bazar, Bangladesh, according to one of the refugees and also the ID cards they held. They already have UNHCR cards. They ran away from Cox’s Bazar. They are all Rohingya,” Azharul told BenarNews.

He said they left Bangladesh on Nov. 28, bound for Malaysia. But because the boat was damaged and its engine had died, it drifted at sea until finally coming ashore in Aceh Besar.

The boat arrived in the regency two days after UNHCR again implored governments in South and Southeast Asia to move swiftly to rescue the people on the other boat carrying nearly 200 people.

“This shocking ordeal and tragedy must not continue. These are human beings – men, women and children. We need to see the States in the region help save lives and not let people die,’’ Indrika Ratwatte, UNHCR’s director for Asia and the Pacific, said in a statement Friday.

The U.N. agency cited reports indicating that the people on board had been at sea for a month amid dire conditions and with insufficient food and water.

Authorities in Indonesia, however, are not actively searching the country’s territorial waters around Aceh by sea or air for any boatloads of Rohingya in distress, an official in North Aceh regency, told BenarNews on Saturday.

He said officials in Aceh were monitoring the provincial coastline and would “pick up” any Rohingya boats spotted within 100 meters from shore.

In recent months and years, other boatloads of stateless Rohingya Muslim refugees have landed in North Aceh during their attempts reach Malaysia or Indonesia, both Islamic-majority countries.

And as of Christmas Sunday, it remained unclear whether the coast guard and authorities in nearby Malaysia were actively searching for any such boats stranded at sea. On Saturday and Sunday, Malaysian officials did not immediately respond to phone calls and text messages from BenarNews.

BenarNews is an online news service affiliated with Radio Free Asia.

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Junshi Biosciences and Coherus Share Update on the FDA Review of the Biologics License Application (BLA) for Toripalimab as Treatment for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

– FDA has been unable to travel to China to conduct the required site inspection resulting in delayed action on the BLA –

– Junshi Biosciences and Coherus are actively engaged in ongoing discussions with the FDA to support the inspections and gain approval of toripalimab for patients with NPC in the U.S. as quickly as possible –

SHANGHAI, China and REDWOOD CITY, Calif., Dec. 25, 2022 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) today announced that the companies have not received an action letter from the U.S. Food and Drug Administration (FDA, the Agency) regarding the Biologics License Application (BLA) for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC) by the Prescription Drug User Fee Action (PDUFA) date of December 23, 2022.

The FDA previously communicated that an on-site inspection of Junshi Biosciences’ manufacturing facility for toripalimab is required before the Agency can approve the application; however, they were unable to conduct the inspection during the current review cycle due to the ongoing impact of COVID-19 related restrictions on travel in China. The BLA for toripalimab remains under review, and Junshi Biosciences and Coherus are engaged in ongoing discussions with the Agency about the pre-approval inspection plans.

“Although toripalimab’s BLA review process has been impacted by the COVID-19 pandemic, we believe the impact is temporary,” said Dr. Sheng Yao, Senior Vice President of Junshi Biosciences. “Together with our partner Coherus, we are working with the FDA to expedite the facility inspection so it may be conducted safely as soon as possible in order to provide NPC patients with a treatment that has been demonstrated to be safe and effective. Our production operations are well prepared for the inspection.”

“There is a significant unmet need for those living with NPC, and toripalimab has demonstrated significant and clinically meaningful improvement as recognized by the FDA’s Breakthrough Therapy Designation. Both Coherus and the FDA are highly committed to bringing toripalimab to NPC patients in the U.S. as quickly as possible,” said Theresa LaVallee, Ph.D., Coherus’ Chief Development Officer. “We are working closely and collaboratively with the FDA to schedule inspections of the manufacturing facility quickly and understand the need to ensure the safety of their inspectors. We continue to support the FDA as needed to allow for their assessment of toripalimab to be finalized.”

The FDA has granted priority review for the toripalimab BLA for use in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic NPC and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy. Recurrent or metastatic NPC is an aggressive head and neck tumor which has no FDA-approved treatment options.

About toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD⁠-⁠1 receptor at a unique site that minimizes opportunities for the tumor cell to evade the immune system and decreases PD-1’s expression on the T-cell as a second method of restoring the body’s immune response.

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 designations for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer (“SCLC”).

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 an anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for the treatment of various cancers 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. As of December 3, 2021, over 700,000 patients have been treated with bamlanivimab or bamlanivimab and etesevimab, potentially preventing more than 35,000 hospitalizations and at least 14,000 deaths. Meanwhile, VV116, a new oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, is in global Phase III clinical trials. A Phase III clinical study (NCT05341609) comparing the efficacy and safety of VV116 versus nirmatrelvir/ritonavir (“PAXLOVID”) for patients with mild to moderate COVID-19 who are at high risk for progression to severe COVID-19, has reached its pre-specified primary endpoint and secondary efficacy endpoint. The study results show that compared to PAXLOVID, VV116 provided patients with a shorter median time to sustained clinical recovery, while achieving statistical superiority. 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 3,100 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://junshipharma.com.

About Coherus BioSciences

Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated through net sales of its diversified portfolio of FDA-approved therapeutics.

In 2021, Coherus in-licensed toripalimab, an anti-PD-1 antibody, in the United States and Canada. The Biologics License Application for toripalimab in combination with chemotherapy as treatment for recurrent or metastatic nasopharyngeal carcinoma is currently under review by the FDA.

Coherus markets UDENYCA® (pegfilgrastim-cbqv), a biosimilar of Neulasta®, and CIMERLI™ (ranibizumab-eqrn), a biosimilar of Lucentis®, in the U.S., and expects to launch the FDA-approved Humira® biosimilar YUSIMRY™ (adalimumab-aqvh) in the U.S. in 2023.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, risks and uncertainties inherent in the clinical drug development process; risks relating to the COVID-19 pandemic; risks related to our existing and potential collaboration partners; risks of the drug development position of Coherus’ competitors; the risks and uncertainties of the regulatory approval process, including the speed of regulatory review, international aspects of Coherus’ business, the need to schedule inspections in China and the timing of Coherus’ regulatory filings; the risk of FDA review issues; the risk of Coherus’ execution of its change in strategy from a focus on biosimilars to a strategy using cash from its portfolio to fund an oncology franchise; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus’ drug candidates; and the risks and uncertainties of possible litigation. All forward-looking statements contained in this press release speak only as of the date of this press release. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the significant risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Annual Report on Form 10-Q for the quarter-ended September 30, 2022, filed with the Securities and Exchange Commission on November 8, 2022, including the section therein captioned “Risk Factors” and in other documents that Coherus files with the Securities and Exchange Commission.

UDENYCA®, CIMERLI™, and YUSIMRY™, whether or not appearing in large print or with the trademark symbol, are trademarks of Coherus, its affiliates, related companies or its licensors or joint venture partners, unless otherwise noted.

Junshi Biosciences Contact Information

IR Team:
info@junshipharma.com
+ 86 021-6105 8800

PR Team:
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800

Coherus Biosciences Contact Information

Investors:
Marek Ciszewski, SVP Investor Relations
IR@coherus.com

Media:
Jodi Sievers, VP Corporate Communications
media@coherus.com

GlobeNewswire Distribution ID 8720041

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China’s Zhejiang Has 1 Million Daily COVID Cases, Expected to Double

China’s Zhejiang, a big industrial province near Shanghai, is battling around a million new daily COVID-19 infections, a number expected to double in the days ahead, the provincial government said Sunday.

Despite a record surge of cases nationwide, China reported no COVID deaths on the mainland for the five days through Saturday, the Chinese Center for Disease Control and Prevention said Sunday.

Citizens and experts have called for more accurate data as infections surged after Beijing made sweeping changes to a zero-COVID policy that had put hundreds of millions of its citizens under relentless lockdowns and battered the world’s second-largest economy.

Nationwide figures from China had become incomplete as the National Health Commission stopped reporting asymptomatic infections, making it harder to track cases. On Sunday the commission stopped reporting daily figures, which the China CDC then published.

Zhejiang is among the few areas to estimate their recent spikes in infections including asymptomatic cases.

“The infection peak is estimated to arrive earlier in Zhejiang and to enter a period of elevated level around New Year’s Day, during which the daily new infection number will be up to two million,” the Zhejiang government said in a statement.

Zhejiang, with a population of 65.4 million, said that among the 13,583 infections being treated in the province’s hospitals, one patient had severe symptoms caused by COVID, while 242 infections of severe and critical conditions were caused by underlying diseases.

China narrowed its definition for reporting COVID deaths, counting only those from COVID-caused pneumonia or respiratory failure, raising eyebrows among world health experts.

The World Health Organization has received no data from China on new COVID hospitalizations since Beijing eased its restrictions. The organization says the data gap might be due to the authorities struggling to tally cases in the world’s most populous country.

‘Most dangerous weeks’

“China is entering the most dangerous weeks of the pandemic,” said a research note from Capital Economics. “The authorities are making almost no efforts now to slow the spread of infections and, with the migration ahead of Lunar New Year getting started, any parts of the country not currently in a major COVID wave will be soon.”

The cities of Qingdao and Dongguan have each estimated tens of thousands of daily COVID infections recently, much higher than the national daily toll without asymptomatic cases.

The country’s health care system has been under enormous strain, with staff being asked to work while sick and even retired medical workers in rural communities being rehired to help grassroots efforts, according to state media.

Bolstering the urgency is the approach of the Lunar New Year in January, when huge numbers of people return home.

Visits to Zhejiang fever clinics hit 408,400 a day — 14 times normal levels — in the past week, a Zhejiang official told a news conference.

Daily requests to the emergency center in Zhejiang’s capital, Hangzhou, have recently more than tripled on average from last year’s level, state television reported Sunday, citing a Hangzhou health official.

The eastern city of Suzhou said late Saturday its emergency line received a record 7,233 calls Thursday.

 

 

Source: Voice of America

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China’s Foreign Minister Signals Deeper Ties With Russia

Chinese Foreign Minister Wang Yi defended his country’s position on the war in Ukraine on Sunday and signaled that China would deepen ties with Russia in the coming year.

Wang, speaking by video to a conference in the Chinese capital, also blamed America for the deterioration in relations between the world’s two largest economies, saying that China has “firmly rejected the United States’ erroneous China policy.”

China has pushed back against Western pressure on trade, technology, human rights and its claims to a broad swath of the western Pacific, accusing the U.S. of bullying. Its refusal to condemn the invasion of Ukraine and join others in imposing sanctions on Russia has further frayed ties and fueled an emerging divide with much of Europe.

Wang said that China would “deepen strategic mutual trust and mutually beneficial cooperation” with Russia. Warships from the two countries held joint naval drills in the East China Sea last week.

“With regard to the Ukraine crisis, we have consistently upheld the fundamental principles of objectivity and impartiality, without favoring one side or the other, or adding fuel to the fire, still less seeking selfish gains from the situation,” Wang said, according to an official text of his remarks.

Even as China has found common ground with Russia as both come under Western pressure, its economic future remains tied to American and European markets and technology. Leader Xi Jinping is pushing Chinese industry to become more self-sufficient, but Wang acknowledged that experience has shown “that China and the United States cannot decouple or sever supply chains.”

He said that China would strive to bring relations with the U.S. back on course, saying they had plunged because “the United States has stubbornly continued to see China as its primary competitor and engage in blatant blockade, suppression and provocation against China.”

Wang and U.S. Secretary of State Antony Blinken talked by phone late last week. The State Department said that Blinken discussed the need to manage the U.S.-China relationship responsibly and raised concerns about Russia’s war against Ukraine and the threats it poses to global security and economic stability.

Wang accused the U.S. of “unilateral bullying” and said that China would continue to play a constructive role in resolving the Ukraine crisis in its own way, a Chinese foreign ministry statement said.

 

 

 

Source: Voice of America

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Former Rebel Leader Becomes Nepal’s New PM

The leader of former communist rebels became Nepal’s new prime minister Sunday with the support from his ex-opponent and other smaller political parties.

The announcement was made by the office of President Bidhya Devi Bhandari after the Maoist communist party leader Pushpa Kamal Dahal met her to stake his claim for the prime minister following last month’s elections in a major twist in politics in the Himalayan nation.

Dahal has the support of more than half the members of the newly elected House of Representatives, the lower house of Parliament.

He is likely to take the oath of office Monday and prove his majority in the 275-member house later in the week.

Seven parties have pledged their support for Dahal, including his friend-turned-foe, the Communist Party of Nepal (United Marxist-Leninist), led by Khadga Prasad Oli.

Dahal and Oli had partnered in the last parliamentary election in 2017, but midway through the five-year term they began to squabble on who would continue as the prime minister. It was initially agreed that they would share the term, but Oli apparently refused, angering Dahal.

Dahal abandoned the partnership and aligned with Sher Bahadur Deuba and his Nepali Congress party to be part of a new coalition government that was led by Deuba.

After the Nov. 20 elections, Deuba and Dahal fell out after failing to agree on who would become the prime minister.

Dahal, also known as Prachanda, or the “fierce one,” led a violent Maoist communist insurgency from 1996 to 2006. More than 17,000 people were killed and the status of many others remains unknown.

The Maoists gave up their armed revolt, joined a U.N.-assisted peace process in 2006 and entered mainstream politics. Dahal’s party secured the most parliamentary seats in 2008 and he became prime minister but quit a year later over differences with the president.

Before the elections, Dahal told The Associated Press in an interview that his main goal was to give the country a stable government that would complete the full five-year term.

Nepal has been hampered by political instability, frequent changes in government and squabbles among parties, which has been blamed for delays in writing the constitution and slow economic development.

No government since the abolition of the centuries-old monarchy in 2008 has completed a full term.

 

 

 

Source: Voice of America

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58 Weak Rohingya Land on Indonesian Beach After Weeks at Sea

Dozens of hungry and weak Rohingya Muslims were found on a beach in Indonesia’s northernmost province of Aceh on Sunday after weeks at sea, officials said.

The group of 58 men arrived on Indrapatra beach at Ladong, a fishing village in Aceh Besar district, early Sunday, said local police chief Rolly Yuiza Away. Villagers who saw the group of ethnic Rohingya on a rickety wooden boat helped them to land and then reported their arrival to authorities, he said.

“They look very weak from hunger and dehydration. Some of them are sick after a long and severe voyage at sea,” said Away, adding that the men received food and water from villagers and others as they waited for further instructions from immigration and local officials in Aceh.

At least three of the men were rushed to a health clinic for medical care, and others are also receiving various medical treatments, Away said.

The United Nations and other groups on Friday urged countries in South Asia to rescue as many as 190 people believed to be Rohingya refugees aboard a small boat that has been adrift for several weeks in the Andaman Sea.

“Reports indicate those onboard have now remained at sea for a month in dire conditions with insufficient food or water, without any efforts by States in the region to help save human lives,” the U.N. refugee agency, UNHCR, said in a statement. “Many are women and children, with reports of up to 20 people dying on the unseaworthy vessel during the journey.”

Away said it wasn’t clear where the group was traveling from or if they were part of the group of 190 Rohingya refugees that has been adrift in the Andaman Sea. But one of the men who spoke some Malay said they had been at sea for more than a month and had aimed to land in Malaysia to seek a better life and work there.


More than 700,000 Rohingya Muslims have fled from Buddhist-majority Myanmar to refugee camps in Bangladesh since August 2017, when the Myanmar military launched a clearance operation in response to attacks by a rebel group. Myanmar security forces have been accused of mass rapes, killings and the burning of thousands of homes.

Groups of Rohingya have attempted to leave the crowded camps in Bangladesh and travel by sea in hazardous voyages to other Muslim-majority countries in the region.

Muslim-dominated Malaysia has been a common destination for the boats, and traffickers have promised the refugees a better life there. But many Rohingya refugees who land in Malaysia face detention.


Although Indonesia is not a signatory to the United Nations’ 1951 Refugee Convention, the UNHCR said that a 2016 presidential regulation provides a national legal framework governing the treatment of refugees on boats in distress near Indonesia and to help them disembark.

These provisions have been implemented for years, most recently last month when about 219 Rohingya refugees, including 63 women and 40 children, were rescued off the coast of North Aceh district aboard two rickety boats.

“We urge the government of Indonesia to rescue the boats and allow them to safely disembark,” Amnesty International Indonesia’s executive director Usman Hamid said. “We also urge the Indonesian government to lead a regional initiative to resolve the refugee crisis.”

On Thursday, the U.N. special rapporteur on the situation of human rights in Myanmar, Tom Andrews, urged governments in South and Southeast Asia “to immediately and urgently coordinate search and rescue for this boat and ensure safe disembarkation of those aboard before any further loss of life occurs.”

“While many in the world are preparing to enjoy a holiday season and ring in a new year, boats bearing desperate Rohingya men, women and young children, are setting off on perilous journeys in unseaworthy vessels,” Andrews said in a statement.

 

 

 

Source: Voice of America