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

Three more bodies recovered from waters after sinking of Thai navy ship

Three more bodies have been recovered from the waters after a Thai warship went down in the Gulf of Thailand a week ago, the kingdom’s navy said Sunday, Trend reports citing Al Arabiya.

 

The HTMS Sukhothai sank on December 18 roughly 37 kilometers (22 miles) off Thailand’s southeastern coast, with a massive rescue operation managing to pull 76 crew alive from the waves.

 

“We found three bodies which will be brought into an identification and autopsy process, which will take about three or four days,” said navy spokesperson Pogkrong Montradpalin.

 

He said in case of an oil leak, the area around the vessel and two others that sank that day had been declared a “disaster prevention zone.”

 

The navy increased the death toll to 18 with one body found on Saturday confirmed as a crew member and a further two discovered, although Pogkrong did not give any further details.

 

Eleven members of the 105-strong crew are still missing, the navy said.

Helicopters, unmanned surveillance aircraft and warships have been combing the sea in hope of finding survivors.

 

On Tuesday, Admiral Chonlathis Navanugraha called the incident “one of the most severe tragedies” in the navy’s history.

 

The vessel – a corvette, among the smallest of military warships – ran into trouble after its electronics system was damaged.

 

The Sukhothai was commissioned in 1987 and built in the United States by the now-defunct Tacoma Boatbuilding Company, according to the US Naval Institute.

 

Source: TREND News Agency

Chinese businessman Tuhao’s Thai wife and business partner arrested

The Metropolitan Police took the Thai wife of Chinese businessman Chaiyanat Kornchayanant, aka “Tuhao”, into custody yesterday (Saturday), on charges of money laundering.

 

Another Thai woman, “Patcharin”, who is suspected of being Kornchayanant’s business partner, was also taken into custody in connection with “grey” businesses, allegedly involving drug trafficking, money laundering and transnational criminal activities.

 

Police apprehended Kornchayanant’s wife, who is a police officer, and his business partner after the Bangkok South Criminal Court issued warrants for their arrests, based on a request from Yan Nawa police.

 

Pol Maj-Gen Thiradet Thammasutee, chief of the Investigation Division of Metropolitan Police Bureau, claimed that police had obtained sufficient evidence to implicate the two women for alleged involvement in criminal activities linked with Kornchayanant’s businesses.

 

The two suspects are being held at Yan Nawa police station for questioning.

 

Eight suspects have, to date, been held in police custody, with seven more under police investigation, said Thiradet.

 

Kornchayanant is currently being held in the Central Corrections Institute for Drug Addicts. He is rumoured to have close connections with a former heavyweight figure in the ruling Palang Pracharath Party. He reportedly donated about three million baht to the party.

 

Source: Thai Public Broadcasting Service

Three more bodies recovered, 11 still missing from HTMS Sukhothai

Three more bodies, believed to be crew from HTMS Sukhothai, were recovered from the sea on Sunday, the seventh day of the extensive search operations, both on the sea’s surface and underwater, Royal Thai Navy (RTN) Spokesman Admiral Pokkrong Monthatphalin said this evening (Sunday).

 

He said that the recovery of the bodies today leaves 11 crew still unaccounted for, adding that all the remains will be sent for DNA identification, which will take up to 4 days.

 

One body was identified today as Seaman Worapong Boonlakorn, attached to the coastal anti-aircraft command. His remains will be flown from the 6th Air Wing at Don Mueang airport to U-Tapao airbase in Chon Buri Province on Monday for a proper funeral, said Admiral Pokkrong.

 

The RTN’s Commander-in-Chief, Admiral Choengchai Chomchoengpaet, is scheduled to preside over the Royally-sponsored cremation of three naval officers at Sattahip naval base in Chon Buri.

 

In Kap Choeng district of Surin Province, Rear Admiral Samoraphum Chantho, deputy commander of the Marine Corps, presided over the Royally-sponsored cremation of Chief Petty Officer First Class Somkiat Maichob at Rao Nakhon Temple.

 

HTMS Sukhothai had a compliment of 105 crew on board on December 18th, when it foundered at sea off Bang Saphan district of Prachuap Khiri Khan. 76 have been rescued, 18 have been found dead and their remains have been recovered and, so far, seven of those have been identified. 11 are still missing.

 

Source: Thai Public Broadcasting Service

Bhumjaithai Party ready to join any party to form the next government

The Bhumjaithai Party is ready to join hands with any party to form a new government, after the next general election. Its leader, Anutin Charnvirakul, is qualified to be the next prime minister, according to Newin Chidchob, a former key member of the party, in an exclusive interview with Thai PBS.

 

Although he used to be in conflict with fugitive former prime minister Thaksin Shinawatra, who is considered the de facto leader of Pheu Thai Party, Newin said he is now just an ordinary member of the Bhumjaithai Party, and the party leader Anutin has never had a conflict with Thaksin.

 

“I have nothing to do with the Bhumjaithai Party’s affairs. I am just a headmaster, an “Uncle Newin”. It is the party’s business to deal with (the matter), because I am just a party member, not an executive. The people who are now in the Bhumjaithai, Pheu Thai, Democrat or Palang Pracharath parties are not in conflict with one another, so why can’t theyjoin together?” asked Newin, currently manager of the Buri Ram soccer team who is, however, still regarded as the de facto leader of Bhumjaithai Party.

 

“If their policies are compatible and beneficial for the people, everything is possible,” said Newin.

 

Regarding Anutin, he said that, about four years ago, the Bhumjaithai party leader barely understood the context of grass roots or rural people but, after occupying the post ofpublic health minister for almost four years, he said Anutin has learned about the sufferings of the people, the impacts of the COVID 19 pandemic on the economy and so on.

 

“I think that he (Anutin) is ready (to assume the premiership post),” said Newin, adding that, in Thai politics, it is axiomatic that there are neither real friends nor permanent foes.

 

As long as the country is divided by ‘coloured-shirt’ politics, he said that there is no way for Thailand to move forward, adding that one thing that has allowed Buri Ram to prosper and advance in the past decade, compared to many other provinces, is “because we do not have ‘colour’ politics.”

 

He said Anutin has proven to the people, in his capacity as deputy prime minister and public health minister, that the Bhumjaithai party keeps its promises to the people.

 

The veteran former politician claimed he has already washed his hands of politics and has found happiness in life working with his football team.

 

“I will never go back to hell (politics) again,” he told Thai PBS, adding however that he is willing to offer political advice if asked.

 

As for his son, Chaichanok, who has joined the Bhumjaithai Party to contest the next election in his hometown of Buri Ram, Newin said he would not stop his son, but will let him learn by himself.

 

“If he is happy, he can go on but, if not, he can come back,”he said as, he denied that he has groomed his son to be the next political heir of the Chidchob family.

 

Source: Thai Public Broadcasting Service

Deadly winter blizzard leaves US in pre-Christmas deep freeze

A fearsome winter storm that pummelled the United States with blinding snow and powerful Arctic winds left over half a million customers without power Saturday as thousands of cancelled flights stranded travelers making last-minute dashes for Christmas.

 

At least 17 weather-related deaths have been confirmed across eight states as heavy snow, howling winds and dangerously frigid temperatures kept much of the nation, including the normally temperate south, in a frozen grip for a third straight day.

 

In hard-hit New York state, Governor Kathy Hochul deployed the National Guard to Erie County and its main city Buffalo, where authorities said emergency services have essentially collapsed in the face of extreme blizzard conditions.

 

One couple in the lake-side city, which sits across the border from Canada, told AFP that with the roads completely impassible, they would not be making a 10-minute drive to see their family for Christmas.

 

“It’s tough because the conditions are just so bad… a lot of fire departments aren’t even sending out trucks for calls,” said 40-year-old Rebecca Bortolin.

 

Her fiancee Ali Lawson is having back pain, but plans to tough it out at home because driving to the hospital is just too dangerous.

 

“We can currently see across the street, but last night we couldn’t see past our porch,” said Lawson.

 

The “bomb cyclone” winter storm, one of the fiercest in decades, had already forced the cancellation of over 2,800 US flights on Saturday and the delay of over 6,600 more, a day after nearly 6,000 were scrapped, according to tracking website Flightaware.com.

 

Transportation Secretary Pete Buttigieg tweeted Saturday that “the most extreme disruptions are behind us as airline and airport operations gradually recover” — words that travelers stranded at airports including Atlanta, Chicago, Denver, Detroit and New York were holding on to.

 

New York City resident Zack Cuyler, whose flight home to Houston on December 22 has been postponed then cancelled twice this week already, was “pretty steamed” about the chaos.

 

The 35-year-old now hopes to reach his loved ones by December 25. “I’m just glad I’ll get to see my family for Christmas,” he told AFP.

 

Road ice and white-out conditions also led to the closure of some of the nation’s busiest transport routes, including the cross-country Interstate 70, parts of which were temporarily shut down in Colorado and Kansas.

 

The National Weather Service warned about lethal conditions and urged residents in affected areas to remain indoors. On Friday, it said wind chills had sent temperatures plunging to -55 Fahrenheit (-48 Celsius).

 

The biting cold is an immediate concern for the nearly 530,000 electricity customers who were still without power as of 2200 GMT Saturday, according to tracker poweroutage.us.

 

Some cities, including in the state of North Carolina, began implementing rolling blackouts due to high power demand, in some cases leaving people unable to safely heat their homes.

 

– Frustration growing –

In El Paso, Texas, desperate migrants who had crossed from Mexico huddled for warmth in churches, schools and a civic center, Rosa Falcon, a school teacher and volunteer told AFP.

 

But some still chose to stay outside in frigid temperatures because they feared attention from immigration authorities, she added.

 

In Chicago, Burke Patten of Night Ministry, a nonprofit dedicated to helping the homeless, said: “We’ve been handing out cold weather gear, including coats, hats, gloves, thermal underwear, blankets and sleeping bags, along with hand and foot warmers.”

 

The National Weather Service forecast that dangerously cold conditions would continue throughout the central and eastern United States over the weekend before temperatures returned to more normal seasonal weather next week.

 

Canadian authorities have also issued severe weather warnings. Hundreds of thousands were left without power in Ontario and Quebec provinces, while many flights were cancelled at airports in Vancouver, Toronto and Montreal, and some trains stalled.

 

– Flooding, fierce winds –

In the US, transportation departments in several plains states reported near-zero visibility whiteouts, ice-covered roads and blizzard conditions, and strongly urged residents to stay home.

 

Drivers were being warned not to take to the roads — even as the nation reached what is usually its busiest time of year for travel.

 

By Friday afternoon, the storm had acquired the status of “bomb cyclone” after air pressure dropped precipitously over 24 hours.

 

Bomb cyclones produce heavy rain or snow. They can also cause flooding at coasts, and generate hurricane-force wind.

 

Meteorologist Kelsey McEwen in Toronto tweeted that waves of up to 26 feet (eight meters) were reported in Lake Erie, while in Ohio’s Fairport Harbor, winds gusted to 74 miles (120 kilometers) per hour, the NWS tweeted.

 

Source: Thai Public Broadcasting Service

Petrol pump at PTT service station in Yala torched

Suspected southern insurgents set fire to a petrol pump at a service station in Than To district of the southern province of Yala on Saturday night. There were no casualties.

 

Than To police said that, shortly before midnight last night, an explosion was heard at the PTT station on Road 410 in Than To sub-district. Police were dispatched to the scene to investigate.

 

They found a pump on fire and alerted the fire brigade. It took about half an hour before the fire was brought under control, but the pump was destroyed.

 

The service station was cordoned off, to allow members of an explosive ordnance disposal (EOD) unit to search the area for any concealed explosive devices. None were found.

 

Source: Thai Public Broadcasting Service