2019-08-10| Asia-PacificR&D

Weekly in Asia 2019|AUG

by GeneOnline
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20190804-0810 Weekly in Asia

Rakuten Medical raises USD 100 million to Accelerate the Development of Photoimmunotherapy.

On July 31, 2019, Rakuten Medical, Inc., a clinical-stage biotechnology company developing Photoimmunotherapy (PIT) platform, announced that the company has raised approximately US $100 million from Rakuten, Inc., its parent company,

a global leader in internet services headquartered in Japan, to advance its pipeline of PIT oncology prospects, strengthen its business and commercial functions, and further identify and evaluate the potential treatment of cancers using PIT.

PIT is an anti-cancer treatment that utilizes monoclonal antibodies conjugated to a dye (IRDye® 700DX). The targeted binding of monoclonal antibody-dye conjugate to a specific antigen on the cell surface. Subsequent illumination with non-thermal red light (690 nm) result in rapid and selective cell killing and tumor necrosis with minimal effects on surrounding normal tissue. PIT may also enhance innate and adaptive immunity.

About Rakuten Medical

Rakuten Medical is a privately funded, clinical-stage, global biotechnology company. The company’s proprietary photoimmunotherapy platform is being studied in ongoing clinical trials, evaluating its safety and effectiveness as a cancer-treatment option that can be administered independently, or in combination with other drugs.



Overheated South Korean Biotech Seeks Balance

In drug development, the cost of Phase-3 trials for new drugs are about ten times higher than that for phase-2 trials. The risk is high, but once completing phase-3 clinical trials and receiving approval from the United States Food and Drug Administration (FDA), the profit is huge. Many biotechnology ventures seek to conduct their own phase-3 trials. In addition, while undertaking , a company’s stock price can go up on expectations before trial results come out.

On the other hand, companies will not be able to survive if they fail to commercialize a new drug as phase-3 clinical trials take an astronomical amount of investment.

SillaJen, Inc., a South Korea based clinical-stage biotherapeutics company focused on the development of oncolytic immunotherapy, announced on August 4th that it will suspend the global phase 3 clinical trial for its oncolytic viral drug, Pexa-Vec, as it failed an earlier liver cancer trial. The Independent Data Monitoring Committee (IDMC) advised the company to discontinue the trial.

Industry observers say that many Korean biotechnology companies are now reconsidering their strategy towards the market due to the SillaJen case. Some analysts suggest that biotechnology firms would do well to pursue technology exports and pipeline diversification, rather than focus on phase-3 clinical trials.

CStone to Build Global R&D Headquarters and Industrialization Base in the Suzhou Industrial Park

As the world’s second-largest pharmaceutical market, China is now the biggest emerging market for pharmaceuticals, expected to reach $145-175 billion by 2022, according to IQVIA.

After 25 years of development, the China-Singapore Suzhou Industrial Park has driven substantial economic cooperation with other countries.

China’s leading biopharmaceutical company CStone Pharmaceuticals is building its Global R&D Headquarters and Industrialization Base in Suzhou Industrial Park to expand capabilities for full commercial scale manufacturing. The signing ceremony was held on August 6.

According to the agreement, the new facility will have a production capacity of 26,000L for macromolecule biologics and one billion capsules for small molecule drugs.

About Cstone Pharmaceuticals

Cstone Pharmaceuticals is a biopharmaceutical company devoted to the development of a new generation of innovative drugs. The company develops cancer therapeutics with a focus on immuno-oncology based combination therapies. It engages in developing model for drug development with a focus on clinical development.



Gene-targeted Animal Model CRO Biocytogen Raisess $77M in Series D

As China starts to take an active role in early and innovative drug research, its contract research organization (CRO) industry is also expanding.

Biocytogen, a Beijing-headquartered CRO specialized in gene-targeted animal models and related services, has just closed a USD 77 million series D round, jointly led by investment giants China Life Healthcare Fund, SDIC Venture Capital Co., Ltd., CMB International and 3E Bioventures. In 2018, the company raised $65 Million in a C round. Biocytogen announced that the raised money will be used in market expansion, product and service development, and the construction of new antibody production facilities.

About Biocytogen

Biocytogen was founded in 2009 and is headquartered in Beijing, with three affiliates both in the U.S. and China. The Company generates custom gene-modified animal models/cell lines, breeds and produces animal models, and provides preclinical in vivo efficacy study services for antibody drug discovery and development.



Lumosa’s LT3001 Taiwan Phase II Clinical Trial to be Launched

Lumosa therapeutics announced on August 7th that the IND submission for the phase 2 study of its novel drug, LT3001, for the treatment of acute ischemic stroke (AIS), has been approved by the Taiwan Food and Drug Administration (TFDA). Lumosa will launch a Phase II clinical trial in Taiwan and the United States. Lumosa plans to complete subject enrollment in 2020. LT3001 is a novel small molecule for the treatment of AIS. Its functions such as restoring cerebral blood flow and reducing ischemic/reperfusion injury have been verified by animal studies. The safety, tolerability and pharmacokinetic exploration of LT3001 has been established through the completion of the Phase 1 trial involving 16 healthy volunteers.

About Lumosa Therapeutics

Lumosa Therapeutics Co., Ltd. is a Taiwan-based company principally engaged in the development of new drugs for unmet medical needs in the fields of central nervous system (CNS), oncology, and inflammatory diseases.





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