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
info@junshipharma.com
+ 86 021-6105 8800

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 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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MOE CALLS ON SCHOOLS TO AVOID OUTDOOR ACTIVITIES DURING HOT WEATHER

The Ministry of Education (MOE) has once again advised all schools to not organise any activities outside the classroom, such as cross-country runs and sports activities, for the safety of students, given that the weather condition is still hot at the moment.

Education Minister Fadhlina Sidek said the MoE held a session with all education departments in the state to provide guidance to ensure that schools do not conduct outdoor activities at this time.

“The MoE has advised schools not to organise activities outside the classroom at this time due to the hot weather, but the postponement is temporary and depends on the (prevailing) weather conditions.

“However, there are some states where the weather is improving, so we will monitor from time to time and give guidance and advice accordingly.

“Just for the time being, I ask all schools to temporarily postpone (activities outside the classroom) until the weather really returns to normal and students can do outdoor activities safely as we need to take precautions,” she said here today.

Fadhlina, who is also the Member of Parliament for Nibong Tebal, was met at the parliamentary constituency’s Aidilfitri open house at Dewan Dato’ Haji Ahmad Salleh in Kampung Permatang Keling here, which was also attended by Education director-general Datuk Pkharuddin Ghazali and Penang Education director Abdul Rashid Abdul Samad.

Fadhlina said this when asked to comment on parental concerns about the health of school children who are at risk of heat stroke if schools conduct outdoor activities such as cross-country runs and sports activities in the current heatwave.

Meanwhile, Fadhlina said that so far no school has been closed due to the hot weather, but her ministry was taking various approaches and remains on alert for any eventuality.

“The Ministry of Health is always vigilant while management related to guidelines and monitoring are strictly carried out by the Ministry of Health and the Ministry of Natural Resources, Environment and Climate Change to ensure the situation is under control,” she said.

Previously, the MoE issued a statement allowing administrators to close schools if the daily temperature status for hot weather is at warning level 2 with the highest temperature exceeding 37 degrees Celsius for three consecutive days.

Source: BERNAMA News Agency

SHORTAGE OF SUGAR SUPPLY IN KELANTAN, TERENNGGAU NOT A CRISIS – KPDN

The issue of sugar shortage in Kelantan and Terengganu was due to workers of the manufacturing company and distribution centre taking long leave, and not a crisis caused by supply disruption in the market.

Domestic Trade and Cost of Living (KPDN) Minister Datuk Seri Salahuddin Ayub said the issue was addressed after the Ops Manis integrated enforcement operations whereby major wholesalers in both states received supplies in stages to distribute to retailers and wholesalers.

“On average, the use of sugar for east coast states is 400 metric tonnes weekly. We have also increased the sugar supply by 35 per cent or 614.12 metric tonnes for four days to meet the demand,” he told reporters after attending an Aidilfitri Rahmah Open House, here today.

The ministry launched Ops Manis from May 3 to 6 to address sugar shortage in the two states.

In a separate development, Salahuddin said the government will continue the Payung Rahmah initiative by announcing a Rahmah insurance scheme for vehicles and residences within two weeks.

“The initial stage of the scheme will involve protection for used vehicles that have engine or gearbox damage as well as protection for homes that are often affected by floods,” he said.

Source: BERNAMA News Agency

FISH NOODLING PROGRAMME OFFERS ONE-OF-A-KIND EXPERIENCE TO YOUTHS

‘Ngoca’ ikan, or fish noodling, where participants wallow around in the mud trying to catch fish with their bare hands, can actually be a unique and exciting experience for the current generation of youth, who are more accustomed to gadgets for their entertainment.

When the Kampung Kuala Sungga village development and safety committee decided to hold a ngoca ikan programme in conjunction with the Aidilfitri celebrations recently, local resident, Nazaliza Mat Nazri, 37, jumped at the chance to let her two children join in the fun and experience the traditional way of catching fish, just as she had done in her childhood.

“This event isn’t always held so when there is a chance, we can let them join in and experience such a new and rare activity firsthand.

“If their clothes get dirty, we can wash them, what’s important is they have fun and play with their peers,” she told reporters at the event, held at a canal at Kampung Kuala Sungga, Tebong here today.

About 200 participants of all ages decided to try their hand at the fish noodling event, and one young participant, Ahmad Zawawi Zulkifli, 11, said that he felt excited to be able to experience catching fresh water fish like fighting fish and catfish with his bare hands.

Another participant, Muhammad Irfan Firdaus Ambia, nine, said although he had to wade through mud he was happy to be able to catch fish together with the villagers and make new friends.

Meanwhile, plantation worker Kholiq Ahmad Tohir, 31, who walked away with the event’s main prize, shared that he would go out fish noodling in the area during his free time as it was his hobby.

The Indonesian, who hails from Tanah Jawa, said that he won first prize after managing to catch a four-kilogramme catfish with his hands after spending a half hour looking around at the banks of the canal.

“In my own village we used to do such fishing events, so I do feel happy to be able to join in, and the villagers do welcome me to catch fish with them,” he said.

Melaka Health, Human Resources and Unity Committee chairman Ngwe Hee Sem said the fish noodling programme could be considered as an annual programme to ensure this traditional activity would not be forgotten by future generations.

“Ngoca ikan, or noodling for fish together in rivers, canals or ponds do seem to bring the community together and create harmony and I do encourage this programme to held in the future,” he added.

Source: BERNAMA News Agency

25TH LABUAN INTERNATIONAL SEA CHALLENGE 2023 OFFERS RM240,000 WORTH OF PRIZES

The 25th Labuan International Sea Challenge (25th LISC) 2023, which kicks off next Tuesday (May 9), is expected to draw a huge crowd to Labuan International Business and Financial Centre.

The prestigious Labuan annual championship featuring 15 events, is expected to attract more than 1, 000 foreign and local participants, and is offering a total of RM240, 000 worth of prizes.

Labuan Corporation (LC) chief executive officer Rithuan Ismail said the curtain-raiser of the 25th LISC is the DAIWA Deep Sea Challenge is scheduled to be flagged off on May 9 at the Public Marina jetty.

“We expect more than 20,000 people will be in Labuan for the 25th series of LISC from May 8 -14, which is double from the number we received in the last year’s LISC.

“We are fully prepared to receive the inflow of visitors to witness this year’s full-blast 25th LISC,” he said at a press conference here today.

LISC’s main event will be the deep sea fishing tournament, DAIWA Deep Sea Challenge which offers a total cash prize of RM60, 000 and that has attracted foreign anglers from French, Australia, Canada and Brunei.

“Of course, anglers from Borneo Island of Sabah and Sarawak, Labuan, and across Malaysia will also be taking part in this deep sea fishing tournament, as teams from Sabah had won a number of games in the past,” he said.

Rithuan said a total of 213 anglers in 21 fishing vessels are taking in the fishing tournament.

He said another two main events are Labuan Cross Channel Swimming Challenge and Labuan Round Island Kayak Race, and the cash prizes for the three main events totalled RM123, 600.

Rithuan said other events include TikTok Most Creative LISC 2023, squid catching competition, Borneo Martial Arts Expo (BMAEX) Semi Pro Edition 2023, Karaoke Duo/Group competition and newly-introduced boat race tournament.

Other supporting games that had been listed throughout the event are beach sports such beach volleyball, beach rugby, LISC Run 2023, LISC petanque beach tournament and coastal fishing among others.

The annual event, which began in 1997, has given Labuan a positive image internationally due to the international participation, especially in the LISC international fishing tournament, Labuan Cross Channel Swimming Challenge and Labuan Round Island Kayak Race.

Rithuan said the five-day event is held in collaboration with government agencies, non-governmental organisations (NGOs), LDA Holdings Sdn Bhd, Labuan Media Practitioner Association and local residents.

Source: BERNAMA News Agency