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KUALA LUMPUR, Dec 14 (Bernama) — AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced a new partnership with I-MAB Biopharma.

The I-MAB treatment being developed is approaching late-phase clinical trials and AGC Biologics will manufacture the materials at its site in Seattle, while also supporting the launch readiness of I-MAB’s product.

AGC Biologics operates multiple mammalian cGMP manufacturing lines and a variety of scales at its Seattle cell culture facility.

The site is designed for capacity and technological flexibility, and has an extensive variety of single-use and stainless steel systems that meet the latest guidelines required for cGMP compliance, with the Seattle site having a long history of successful inspections by the FDA and approved for commercial production.

Based on a statement, these features and capabilities combined make the AGC Biologics Seattle facility an ideal location to support I-MAB’s goals and bring this treatment through its next clinical phase.

“We look forward to partnering with a true pioneer in innovative clinical research and development, and working together to help bring I-MAB’s product through the final clinical stages and to commercialisation,” said Jean-Baptiste Agnus, Chief Business Officer of AGC Biologics.

“Our team in Seattle is an ideal customer-focused group of scientists to help I-MAB in its promising journey for this treatment.”

AGC Biologics’ Seattle facility has capabilities for developing a wide range of mammalian and microbial programs, and has delivered several approved commercial products. Its global network spans the US, Europe, and Asia.

To learn more, visit http://www.agcbio.com.

KUALA LUMPUR, Dec 14 (Bernama) — Biopharmaceutical company, Adagene Inc (Adagene), has announced preclinical data demonstrating the compelling differentiation of ADG153, an anti-CD47 monoclonal antibody (mAb), and ADG152, a CD20xCD3 bispecific T-cell engager (TCE).

The data were presented in two poster presentations at the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition taking place Dec 11-14, 2021 which are available in the Publications section of the company’s website, according to a statement.

“Our novel anti-CD47 antibody and CD20xCD3 bispecific TCE programs successfully leverage SAFEbody technology for precision masking to decouple efficacy from the toxicities that are often associated with therapeutic modalities for these two important targets on the forefront of clinical development for hematologic malignancies,” said Adagene Co-founder, Chief Executive Officer and Chairman, Peter Luo, Ph.D.

“Our preclinical evaluation shows the desirable target product profiles of these two transformative programs emerging from our deep, broad and differentiated pipeline.”

The poster (#3342) titled ‘ADG153, an Anti-CD-47 Monoclonal Antibody Prodrug, Has Strong In Vivo Anti-Tumor Activity, Minimal RBC-Related and Antigen Sink Liabilities, and Extended Half Life in Comparison with Benchmark Clinical Antibodies of the Same IgG Subclass’.

Key findings from the poster include given the dose-limiting hematologic toxicity and antigen sink liability associated with current anti-CD47 antibodies in clinical development, Adagene has developed an anti-CD47 SAFEbody with precision masking for preferential binding on CD47 overexpressed on tumour versus normal cells.

Meanwhile, the poster (#1204) titled ‘ADG152, a Novel CD20xCD3 T-Cell Engager Prodrug with Enhanced Therapeutic Index, Demonstrates Strong Anti-Tumor Activity with Improved Safety’.

Key findings from the poster include ADG152 is a bispecific CD20xCD3 T-cell engager POWERbody that integrates SAFEbody precision masking technology to minimise cytokine release syndrome (CRS) and on-target/off-tumour toxicities for an increased therapeutic index.

Both ADG153 and ADG152 are potential Investigational New Drug candidates from Adagene’s growing portfolio of preclinical discovery programs, five of which are in IND-enabling studies.

The preclinical data presented at ASH provide a strong rationale for advancing these potentially best-in-class candidates into clinical development.

More details at http://www.adagene.com.

— BERNAMA

SINGAPORE & HYDERABAD, India, Dec 9 (Bernama-BUSINESS WIRE) — Prestige BioPharma Ltd. (KRX: 950210) and Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, hereafter referred to as “Dr. Reddy’s”) today announced that the two companies have entered into a binding agreement for an exclusive partnership for the supply and commercialization of Prestige BioPharma’s proposed trastuzumab biosimilar in select countries in Latin America and Southeast Asia.

Prestige BioPharma’s trastuzumab (HD201) is a proposed biosimilar to Roche’s Herceptin® and can be prescribed for the treatment of HER2 positive breast and metastatic gastric cancer. Trastuzumab targets human epidermal growth factor 2 (HER2). In some types of cancer cells, HER2 is overexpressed and stimulates the growth of the cancer cells. Trastuzumab works by selectively binding to HER2, thereby stopping the growth of these cancer cells.

The license agreement grants Dr. Reddy’s the exclusive rights to commercialize the proposed biosimilar in select countries in Latin America and Southeast Asia. Under this partnership, Prestige BioPharma will be responsible for sustainable commercial supply of HD201 from its manufacturing facilities in Osong, South Korea, while Dr. Reddy’s will be responsible for local registrations, marketing and sales in the licensed territories.

Lisa S. Park, CEO of Prestige BioPharma, commented: “We are delighted to establish a partnership with Dr. Reddy’s for key Latin American and Southeast Asian markets. Dr. Reddy’s is the ideal partner to commercialize our lead biosimilar in these territories. With this collaboration, we look forward to further strengthening the value of our biosimilar programs in global markets.”

M.V. Ramana, CEO – Branded Markets (India & Emerging Markets), Dr. Reddy’s, said: “In keeping with our purpose of accelerating access to affordable and innovative medicines, we are happy to bring this life-saving drug to patients in need. Our partnership with Prestige BioPharma will help us combine their established expertise in the area of biosimilars with our commercial strengths and growth ambition in these markets. This is in line with our stated intention to create a portfolio of oncology products and expand our biosimilar offerings in Emerging Markets.”

About Prestige BioPharma Limited:
PRESTIGE BIOPHARMA LTD (PBP) is a Singapore-based biopharmaceutical company with operations in USA and Korea, specialising in the discovery and development of biosimilars, novel antibodies and vaccines. PBP strives to become a global innovator through the development of first-in-class mAbs including PBP1510 anti-PAUF mAb for pancreatic cancer that recently obtained orphan designation from FDA, EMA and MFDS. PBP’s rich portfolio of biosimilars in various stages including HD204 bevacizumab in global Phase 3, PBP1502 adalimumab in Phase 1 and others, is aimed to provide affordable quality medicines to those who need. PBP’s business also includes alliance vaccine development and production, starting with the partnered commercial production of COVID-19 vaccines. For more information, please visit www.prestigebiopharma.com.

About Dr. Reddy’s:
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its businesses, Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com.

View source version on businesswire.com: 
https://www.businesswire.com/news/home/20211208006176/en/

Contact

Prestige BioPharma Limited

Investor Relations
Bumjoon Kim
Bumjoon.kim@pbpsg.com

Corporate Communication
Yujin Suh
yujin.suh@pgpsg.com

Dr. Reddy’s Laboratories Ltd.

Investor Relations
Amit Agarwal
amita@drreddys.com

Corporate Communication
Usha Iyer
ushaiyer@drreddys.com

Source : Dr. Reddy’s Laboratories Ltd.

KUALA LUMPUR, Dec 6 (Bernama) — On Dec 2, a video highlighting the beauty of Vietnam and the launching of regular flights between Vietnam and the United States were displayed on the main billboard at the heart of New York City’s Times Square, attracting global attention.

Captivating landscapes of Vietnam such as the mysterious Son Doong cave and the awe-inspiring and poetic sceneries of Ha Long Bay and Ninh Binh, along with the vibrant and impressive cities of Da Nang, Hanoi, and Ho Chi Minh City, were proudly showcased on the 700 sq. ft LED screen surrounding the iconic 30-storey Thompson Reuters building.

Here, the official launching event of the first Vietnam – US direct commercial flight held on Nov 28 was also introduced, ushering in the next step for economic and cultural exchange between the two countries. This was certainly a special milestone for the development of Vietnamese aviation as a whole and for Vietnam Airlines — becoming the country’s first airline to operate regular direct commercial flights to the US.

Vietnam Airlines will run two flights per week from Ho Chi Minh City to San Francisco with the modern wide-body aircraft: Boeing 787 and Airbus A350. The flight duration is 13 hours and 50 minutes from Ho Chi Minh City to San Francisco, and 16 hours and 40 minutes for the return flight.

The airline plans to increase to seven flights per week once the COVID-19 pandemic is determined to be under control and plans to open a new route to connect Los Angeles to both Hanoi and Ho Chi Minh City.

On Nov 4, the US Federal Aviation Administration (FAA) granted licensing for Vietnam Airlines to operate regular direct flights between the two countries.

According to a statement, the flag carrier is the first and only Vietnamese airline licensed to conduct regular commercial flights to the US.

— BERNAMA

KUALA LUMPUR, Dec 1 — The 2021 IYF Special Dialogue in Nanjing is launching a call for entries themed ‘My Beautiful Hometown’.

As a great opportunity for young people along the silk roads to present the charm of their hometowns to a global audience, it is an ideal platform for them to share their thoughts, stories, and actions on youth leadership in innovation and creativity.

The IYFSD is also a treasured occasion to inspire more youth actions and leadership for a sustainable, inclusive, and resilient shared future for all, according to Nanjing Literature Centre in a statement.

All participants are requested to create a piece of original writing, art creation, or video work speaking for their hometowns, cities or regions, like cultural heritages, unique landmarks, local customs, culinary traditions, or featured handicrafts, with a writing piece of any genre, no more than 150 words in English (or 200 words in Chinese). It is open to all the young population aged between 18 and 45 from countries or regions along the silk roads.

Based on the panel selection, certificates will be awarded to 10 winners for Outstanding Creation, three for Third Prize, two for Second Prize, and one for First Prize, and all participants with eligible submissions will receive Certificates of Recognition.

The submission means that the organisers are granted the non-exclusive rights to use, publish, reproduce, distribute, communicate or make available to the public the creative pieces, and the entrants hereby consent that the work will be used for non-profit educational or public information uses.

In return, a remuneration of 3,000 yuan will be awarded to the First Prize winner, while 2,000 yuan to each Second Prize, 1,200 yuan to each Third Prize, and 600 yuan to each Outstanding Creation.

The results will be announced on the online sharing session which will be held on Dec 17.

— BERNAMA