Weekly in Asia 2019｜JULY-1

The 21st INTERPHEX Week Japan 2019 Concludes on a Successful Note

INTERPHEX, Japan’s largest exhibition for pharmaceutical manufacturing & packaging, ingredients, biopharmaceutical drug discovery and regenerative medicine, took place on 3 days from July 3rd to 5th 2019 in Tokyo.

At the exhibition, more than 1,280 exhibitors coming from 34 countries participated, with attendees exceeding 42,000. AI/IoT in pharma manufacturing, evidence-based medicine, big data, oligonucleotide therapeutics, gene therapy, high potency drugs and antibody APIs, innovation in medicine, regenerative medicine and R&D were the hottest topics in the exhibition. Sony, Meiji, Yahoo, and HITACHI exhibited their technology, such as cell analyzer, The DNA Data Bank of Japan as well as AI/IoT innovative scheme, etc.

The show director, Masaki Soda, mentioned that two newly added exhibitions in the 21st INTERPHEX Week, PharmaLab Japan, and Regenerative Medicine Expo, were the major highlights. Tad Ishizumi, president of Reed Exhibitions (the event organizer), pointed out during his welcome speech at the VIP reception party that 2019 INTERPHEX Week is the largest scale in history. The 2020 INTERPHEX Week will also include Drink JAPAN and Foodtech JAPAN, with an expectation of increasing exhibitors and visitors.

CStone Announces Global Collaboration with Bayer on Combination Therapy for Cancer

China-based CStone Pharmaceuticals and German pharmaceutical and life sciences company Bayer announced on June 10th the collaboration to evaluate the safety and efficacy of a checkpoint inhibitor, PD-L1 monoclonal antibody CS1001, in combination with a multi-kinase inhibitor, regorafenib, for the treatment of multiple cancers, including gastric cancer.

This will become the first global proof of concept study carried out as a collaboration between the two companies. CStone will sponsor the study, while Bayer will provide regorafenib throughout the clinical trial program. Financial terms of the collaboration were not disclosed.

CS1001, as one of CStone’s immuno-oncology pipeline candidates, is currently undergoing seven clinical trials, including five pivotal trials. It demonstrated favorable tolerability profile and anti-tumor activities across different tumor types.

Bayer’s Regorafenib (BAY 73-4506, Stivarga®) is an orally-administered inhibitor of multiple kinases used for the treatment of metastatic colorectal cancer and advanced gastrointestinal stromal tumors. FDA approved on September 27, 2012. Approved use of Regorafenib was expanded to treat hepatocellular carcinoma in April, 2017.

About CStone

Cstone Pharmaceuticals is a biopharmaceutical company devoted to the development of a new generation of innovative drugs with a focus on immuno-oncology based combination therapies.

About Bayer

Bayer produces and markets products that include aspirin, antibiotics, anti-infectives, cardiovascular, oncology, central nervous system drugs, diagnostics, and animal health products.

MacroGenics and I-Mab to Develop and Commercialize Enoblituzumab in Greater China

American biopharmaceutical company MacroGenics, Inc. and China-based I-Mab Biopharma announced on July 10th that the companies have entered into an exclusive collaboration and license agreement to develop and commercialize enoblituzumab, an anti-B7-H3 monoclonal antibody targeting the inhibition of T cell function, in mainland China, Hong Kong, Macau and Taiwan.

I-Mab will lead regional trials and will participate in global studies conducted by MacroGenics. A Phase 2 trial evaluating the combination of enoblituzumab and PD-1 inhibitor MGA012 in head and neck cancer will be launched later this year.

Under the terms of the agreement, MacroGenics will receive USD 15 miilion upfront payment, and up to USD 135 million in milestones and tiered royalties on net sales.

About MacroGenics

MacroGenics, Inc., a biopharmaceutical company, discovers and develops antibody-based therapeutics for the treatment of cancer in the United States. Its pipeline of immuno-oncology product candidates includes innovative monoclonal antibody-based therapeutics for the treatment of cancer.

About I-Mab

I-MAB Biopharma Co., Ltd. develops and manufacture pharmaceutical products. The Company produces monoclonal antibodies, immune cytokines, bispecific antibodies, tumor innovative drugs, and other products.

Hong Kong Biotech SinoMab to IPO on HKEx

On 30 April 2018, the Stock Exchange of Hong Kong Limited (HKEx) started to accept listing applications filed under three new chapters, of which, Chapter 18A was designed to attract pre-revenue biotech companies.

SinoMab Bioscience, a Hong Kong clinical-stage antibody company, reported its filing for a Hong Kong IPO has been accepted by HKEx, marking the first-ever domestic firm to take advantage of new rules.

The pipeline of SinoMab constitutes of a BTK inhibitor, a lead anti-CD22 drug SM03, and four other preclinical monoclonal antibodies. With SM03, SinoMab is targeting some of the biggest indications in immunology.

About SinoMab Bioscience

Founded in 2001 by Dr. Shawn Leung, Sinomab Bioscience Ltd. researches, develops, and manufactures antibody drugs such as anti-infective drugs, antitumor agents, and monoclonal antibodies. Headquartered in Hong Kong, SinoMab has additional facilities in Shenzhen, Hainan and Suzhou.

CMIC Collaborates with Align Clinical CRO to Facilitate Clinical Studies

10 July 2019

As drug innovation has been driven increasingly by the pharmaceutical industry, the community has witnessed a sharp increase in the number of clinical trials. Study designs, qualification requirements and service requests are evolving as well. To shorten the time period for drug development, many pharma and biotech are outsourcing clinical trials to Contract Research Organizations (CROs). According to estimations, by 2020, 72% of clinical trials are expected to be outsourced to CROs. Pre-competitive industry standards can help bring more consistency to trial management and improve sponsor visibility into trial processes.

Japanese leading CRO CMIC Group announced on July 10th that it has become the first Japanese CRO to join Align Clinical CRO, aiming to streamline clinical trials. In the near future, the two companies will help the industry increase productivity, reduce operational costs, thus, enable clinical trials to run efficiently.

About CMIC Group
In 1992, CMIC Group started as the first CRO in Japan. CMIC now provides comprehensive support services for the development, manufacturing, sales, and marketing of pharmaceutical products.

About Align Clinical CRO
Align Clinical CRO is a life sciences industry standards group dedicated to creating open technology standards founded by Veeva Systems and the world’s largest CROs.

References
http://www.cstonepharma.com/en/html/news/2123.html
https://www.macrogenics.com/news/macrogenics-and-i-mab-announce-exclusive-collaboration-and-license-agreement-to-develop-and-commercialize-enoblituzumab-in-greater-china/
https://www.biopharmapress.com/sinomab-first-ever-homegrown-firm-to-take-advantage-of-new-rules-that-allow-pre-revenue-biotech-firms-to-list-on-the-stock-exchange/
https://www.hkex.com.hk/-/media/HKEX-Market/Listing/Rules-and-Guidance/Listing-Rules-Contingency/Main-Board-Listing-Rules/Equity-Securities/chapter_18a.pdf?la=en
https://www.cmicgroup.com/e/news/20190710

Author

GeneOnline