Junshi Biosciences Announces Collaboration with Dr. Reddy’s to Develop and Commercialize Toripalimab in 21 Countries

SHANGHAI, China, May 07, 2023 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) announced a collaboration with Dr. Reddy’s Laboratories Limited (“Dr. Reddy’s”) to develop and commercialize toripalimab, the anti-PD-1 monoclonal antibody in Latin America, India, South Africa, and at the election of Dr. Reddy’s, also in Australia, New Zealand and other countries.

“We are thrilled to have established a partnership with Dr. Reddy’s while toripalimab’s global commercial network has been steadily expanding, reaching more than 50 countries and advancing our mission of being ‘In China, For Global,’” said Dr. Ning LI, Chief Executive Officer of Junshi Biosciences. “Dr. Reddy’s is a well-respected global pharmaceutical company and extends its business over nearly 70 countries worldwide, achieving impressive commerical presence across the globe. We hope that in the near future, leveraging Dr. Reddy’s partnership and strong presence, our innovative medicines can accelerate access to new geographies and deliver better and more affordable treatment options to even more patients.”

M.V. Ramana, CEO – Branded Markets (India & Emerging Markets), Dr. Reddy’s said, “We are pleased to partner with Junshi Biosciences to take this important product to more patients. Oncology is a focus area for Dr. Reddy’s. This partnership is a further step towards increasing our offerings to patients in oncology as we aim to build a robust and comprehensive portfolio in the segment. We are committed to facilitating access to innovative products as we pursue our goal of serving over 1.5 billion patients by 2030.”

Under the license and commercialization agreement, Junshi Biosciences will grant a licence to Dr. Reddy’s to develop and exclusively commercialize toripalimab in Brazil, Mexico, Colombia, Argentina, Peru, Chile, Panama, Uruguay, India and South Africa1. Dr. Reddy’s may elect to expand the scope of the license to cover Australia, New Zealand and nine other countries2.

Under the terms of the agreement, Junshi Biosciences also grants Dr. Reddy’s the exclusive right of first negotiation for commercialization, in the event that Junshi Biosciences determines to grant any third party the rights to commercialize two other products as agreed in the agreement in one or more countries within the total 21 countries of Dr. Reddy’s Territory3.

Junshi Biosciences may receive up to an aggregate of US$728.3 million for upfront payment, potential expansion of Dr. Reddy’s Territory and milestone payment, plus double-digit percentage of royalties on the net sales of products containing toripalimab.

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 promotes the immune system’s ability to attack and kill tumor cells.

More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, 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 six approved indications for toripalimab in China:

  1. unresectable or metastatic melanoma after failure of standard systemic therapy;
  2. recurrent or metastatic NPC after failure of at least two lines of prior systemic therapy;
  3. locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
  4. in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;
  5. in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (“ESCC”);
  6. in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (“NSCLC”).

The first three indications have been included in the National Reimbursement Drug List (NRDL) (2022 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for treatment of melanoma.

In the United States, the Biologics License Application (BLA) for toripalimab in combination with gemcitabine/cisplatin, for the first-line treatment of patients with advanced recurrent or metastatic NPC and toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy is under review by the U.S. Food and Drug Administration (FDA). The FDA has granted Breakthrough Therapy designations for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC. 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).

In Europe, marketing authorization applications (MAA) were accepted by the European Medicines Agency (EMA) and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) for 1) toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC and 2) toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC, in December 2022 and February 2023.

About Dr. Reddy’s

Dr. Reddy’s is a global pharmaceutical company headquartered in Hyderabad, India and listed on the New York Stock Exchange (stock code: RDY), the National Stock Exchange of India (stock code: DRREDDY), and the Bombay Stock Exchange (stock code: 500124). Established in 1984, Dr. Reddy’s is committed to providing access to affordable and innovative medicines. Driven by its purpose of ‘Good Health Can’t Wait’, Dr. Reddy’s offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Dr. Reddy’s major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Its major markets include – the United States, India, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, Dr. Reddy’s continues to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, Dr. Reddy’s released its first Sustainability Report in 2004. Its current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.

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 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. In 2021, JS016 (etesevimab), China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2 administered with bamlanivimab, was granted Emergency Use Authorizations (EUA) in over 15 countries and regions worldwide. Meanwhile, VV116 (deuremidevir hydrobromide), a novel oral nucleoside analog anti-SARS-CoV-2 drug designed to hinder virus replication, has been approved for marketing in China and Uzbekistan. The JS016 and VV116 programs are a part of the company’s continuous efforts towards innovation for disease control and prevention of the global pandemic.

Junshi Biosciences has about 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.

Junshi Biosciences Contact Information
IR Team:
Junshi Biosciences
+ 86 021-6105 8800

PR Team:
Junshi Biosciences
Zhi Li
+ 86 021-6105 8800

1 Collectively, “Dr. Reddy’s Territory 1”2 Collectively, “Dr. Reddy’s Territory 2”
3 Both “Dr. Reddy’s Territory 1” and “Dr. Reddy’s Territory 2” are collectively known as “Dr. Reddy’s Territory”, totalling 21 countries.

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Indonesia deploys over 12,000 soldiers, police officers for 42nd ASEAN Summit

The Indonesian National Armed Forces (TNI) and the National Police (Polri) held a security exercise on May 6 for the 42nd ASEAN Summit which will take place from May 9-11 in the town of Labuan Bajo, East Nusa Tenggara province.

National Police Chief Gen. Listyo Sigit Prabowo said over 12,000 soldiers and police officers will be deployed in three areas from May 7-13. Various scenarios have been outlined to protect the ASEAN Summit from different types of threats, ranging from criminal activities, protests, security disturbances, cyber attacks, to unexpected natural disasters.

Earlier, the host deployed a large capacity ship as a place to accommodate foreign journalists during the event.

The ship will provide free accommodation services from May 7-12 for more than 1,900 people in a total of 508 rooms. In addition, there is also an economy class area that can house nearly 1,400 people on board.

The ASEAN Summit is expected to have a wide-ranging impact on the tourism industry of Labuan Bajo and contribute significantly to the recovery of Indonesia’s “smokeless industry” after 3 years of heavy impact from the COVID-19 pandemic.

The Indonesian officials estimated that the event could contribute nearly 341 million USD to the local economy while also promoting the recovery of tourism and micro, small and medium-sized enterprises (MSMEs)./.

Source: Vietnam News Agency

Indonesia develops ASEAN Village Network to support dev’t

Indonesia is determined to form the ASEAN Village Network as a platform for cooperation between member countries’ villages to contribute to and obtain direct benefit from the development in the region. “The focus of the ASEAN village network is cooperation in tourism development, primary product development, and village digitalization,” Villages, Development of Disadvantaged Regions, and Transmigration (PDTT) Ministry’s official Muhammad Fachri said. The village network formation is planned to be conducted officially by ASEAN leaders during the 42nd ASEAN Summit in Labuan Bajo, East Nusa Tenggara, on May 9-11, he said in a statement on Sunday. The ASEAN Village Network is expected to open more opportunities for villages in member countries to benefit from ASEAN’s cooperation with other partners, including the private sector. The first ASEAN Village Network meeting is expected to be implemented in Indonesia in the middle of 2023, under the coordination of the PDTT Ministry. Meanwhile, Foreign Affairs Ministry spokesperson Teuku Faizasyah said cooperation between villages in ASEAN should be encouraged. “This cooperation can be utilized so that each village can share their best experiences to develop their economy,” he said. “This interaction is also expected to contribute to strengthening the identities of fellow ASEAN members,” he added. In Southeast Asia, 64 percent of the population lives in villages, with a 62 percent higher poverty rate compared to the population that lives in cities. This figure shows that the effort to reduce poverty rates and expedite development in the region should prioritize development in villages. Villages are considered to be less empowered, but they have high potential for supporting recovery and constructing the pillar of the Epicentrum of Growth in the region.

Source: Philippines News Agency

Imee seeks regulation of artificial intelligence in BPOs, OEMs

Senator Imee Marcos on Sunday called for an inquiry into the use of artificial intelligence (AI) that poses a major threat to workers in the Business Process Outsourcing (BPOs) and Original Equipment Manufacturing (OEM) industries. ‘AI is developing faster than most people can comprehend and is threatening to take away jobs and turn employment growth upside down,’ Marcos, chairperson of the Senate Committee on Social Justice, Welfare and Rural Development, said in a news release. AI, she said, poses a grave danger to the BPO industry and factory workers who helped the country’s economy at the height of the onslaught of the coronavirus 2019 (Covid-19) pandemic. In 2020 to 2021 or when the world was critically battling the effects of the pandemic, the BPO industry grew by 10 percent to US$29.5 billion. “Will call center agents and factory workers soon be treated as dispensable after propping up our economy during a global health crisis?” she said. Marcos, in her Senate Resolution No. 591, cited the study conducted by Oxford Economics and US-based digital technology company Cisco, that at least 1.1 million jobs in the Philippines will disappear in 2028. Some 50 percent of worldwide organizations are seen adopting AI and automated machines this year, and investments in such technology are projected to increase in the next three years by 50 percent to 100 percent. Amid these projections, Marcos said ‘upskilling and training of workers in special services that AI cannot easily replace must be asserted in the corporate social responsibility (CSR) of every company.’ She also stressed the urgency of educating lawmakers about global developments in AI technology through Senate inquiry, and the need for both the legislative and executive branches of government to deal squarely with ‘an inevitable technological tsunami.’ Marcos added that Congress must formulate regulatory measures against severe unemployment and make the necessary amendments to the Intellectual Property Code, Revised Penal Code and Cybercrime Prevention Act.

Source: Philippines News Agency

6K ‘tourist cops’ deployed for summer, fiestas

Around 6,000 policemen have been deployed to various destinations across the country as part of the ‘Oplan Ligtas Sumvac (summer vacation) 2023’ campaign to ensure the safety of local and foreign tourists, especially during fiesta celebrations this month. In a radio interview on Sunday, PNP spokesperson Col. Jean Fajardo said policemen are patrolling major tourist destinations, including Boracay, Palawan, and Siargao, for traffic management assistance and securing transportation hubs. ‘Yung atin implementation ng ating Oplan SumVac ay nagtutuloy tuloy ‘yan kaya naman ‘yung ating deployment doon sa ating mga major thoroughfares ay nandiyan tayo para umalalay doon sa mga management and control ng traffic… (Our implementation of our Oplan SumVac continues, that’s why our deployment in our major thoroughfares is there to support the management and control of traffic,’ she said. Under Oplan Ligtas Sumvac, all regional and provincial police offices must activate their contingency plans and maximize the deployment of personnel through tourist police units in coordination with local government units, local tourism councils and the Department of Tourism.

Source: Philippines News Agency

Senator shuns NAIA privatization

The privatization of Ninoy Aquino International Airport (NAIA) and other airports would not solve the worsening condition of these facilities, Senator Risa Hontiveros said on Sunday. Instead of pushing for the airports’ privatization as proposed by fellow legislators, Hontiveros suggested that the government should focus on improving management and greater accountability of local airports. ‘Privatization is not the correct prescription to solve the worsening problems of service within our airports,” Hontiveros said in a news release. Operations at NAIA and other local airports will never improve even if the private sector runs them unless management systems are reformed, she said. Hontiveros issued the statement after some colleagues in the Senate brought up the idea of privatizing the airport. Senate President Juan Miguel Zubiri even suggested allowing a foreign firm to run the problematic airport. But the opposition solon disputed such a claim, adding that allowing international firms to manage the airport does not guarantee better services. Worse, they could bring additional toll on the traveling public. She said well-maintained airports around the world like Doha’s Hamad International Airport, Tokyo’s Haneda International Airport, Korea’s Incheon International Airport, Paris’ Charles de Gaulle, and Istanbul Airport are all managed by their respective states. ‘The majority of the best airports in the world remain state-owned. There are plenty of good practices in airport operations for us to emulate if the government is indeed serious about fixing our airports,’ Hontiveros said. The senator echoed the earlier call of House Deputy Speaker Ralph Recto and other officials for an immediate technical system audit of NAIA operations so the government can proactively identify and address its weaknesses. Manila International Airport Authority officer-in-charge Bryan Co said in a statement Friday that with the assistance of power distributor Manila Electric Company (Meralco), the electrical audit of the NAIA Terminal 3 has started following an outage on May 1 that disrupted flights and affected about 9,300 passengers. Meralco said the outage was caused either by faulty wiring or short circuit, which resulted in a high amount of power current and fault indicator.

Source: Philippines News Agency