Week In Review: Human Gene Editing Scandal Revisited; Can China Biopharma Continue To Expand? News O

Industry Insights

In a deeply researched Wall Street Journal article, Preetika Rana provides extraordinary depth into the story of Dr. Jiankui He, the man who announced last November he had used Crispr-Cas9 gene editing to alter human embryos in eight women. Dr. He was widely condemned at the time for the first-in-human experiment, and is probably now imprisoned by China authorities. But Ms. Rana told ChinaBio Today, "Dr. He was a product of a system that encourages breaking scientific and social barriers, with rewards coming first." She continued, "As one of my sources says in the story: 'Of course, he made his own choices. But he was a product of his environment,' Arizona University's Dr. Hurlbut said of Dr. He. 'The narrative of a rogue scientist excuses the rest of science from having played a role. That's just not true.'" We provide a free link for ChinaBio readers to access the Wall Street Journal front page article.

As 1,400 life science executives, investors and entrepreneurs gather in Shanghai for the 11th annual ChinaBio Partnering Forum, they have much to be happy about. Regulatory changes are speeding development and approval timelines for novel imported drugs in China, and VCs raised over $40 billion in new funding last year. But there are things to worry about. Can the tremendous growth in investment activity continue?. The China and US governments seem to be moving towards restricting cross-border activity. Is this an unfounded fear, or is it having a real impact? Is money still flowing out of China into US biotechs? And are US and EU pharmas still partnering their drug candidates with China? The simple answer is "yes," but as with everything in China, the real answer is more complex.

Deals and Financings

Beijing InnoCare Pharma is planning a Hong Kong IPO that could raise as much as $250 million and value the company at a minimum of $800 million, according to informed sources. InnoCare is still early in the process and has not yet chosen investment bankers for the offering. The company, which is developing immunotherapies for cancer and autoimmune diseases, has three molecules in or near clinical trials, including its lead product, a BTK inhibitor that is currently being tested in multiple Phase II trials for cancer.

Viva Biotech (HK: 1873), a Shanghai CRO, raised $194 million in its Hong Kong IPO, and then traded higher in public trading, ending the week with a 14% gain. Viva is a structure-based, integrated drug discovery CRO that offers an Equity for Service model to selected clients. The IPO attracted the heaviest investor interest of any of the first eight Hong Kong pre-revenue biotech IPOs, which caused the underwriters to send more shares to local investors and fewer to international buyers. The IPO priced at the top of the expected range.

Junshi Biosciences (HK: 1877; NEEQ: 833330) filed to IPO on Shanghai's new Technology & Innovation Exchange, after the company completed a $394 million Hong Kong IPO in December 2018. Junshi plans to list 10% of its shares in the IPO, which means the IPO would raise about $400 million before fees. It will be the first biopharma to have a dual Hong Kong/Shanghai High-Tech listing. Junshi did very well after its Hong Kong IPO, rising 65% from the IPO price. In January, Junshi was approved to launch its PD-1 immunotherapy, Tuoyi, for multiple myeloma.

Zai Lab (NASDAQ:ZLAB) completed a $200 million follow-on financing, just eight months after its previous $150 million follow-on round. The company expects to launch two oncology products in China this year, a PARP inhibitor and an electric fields treatment for GBM. It already markets both products in Hong Kong. It will reserve more than one-quarter of its newest funding for business development. The funding was well-received: underwriters upped the number of ADSs available from 5 million to 7.8 million in response to investor interest.

Ally Bridge Group of Hong Kong led an over-subscribed $65 million financing of Pulmonx, a Bay Area pulmonary device maker. Pulmonx develops technologies that improve the lives of patients suffering from COPD. Its major product, Zephyr Valve, is the first minimally-invasive device approved by the US FDA to treat patients with severe emphysema, a life-threatening form of COPD. Since 2007, more than 15,000 patients have been treated with the Zephyr Valve worldwide.

GeneQuantum Healthcare of Suzhou closed a nearly $15 million Pre-B financing, led by Huagai Capital and joined by Hofon Capital and Changjinboya. The company plans to use the funds for global clinical development of its next-gen ADCs, as well as the development of a number of differentiated innovative technologies and products. GeneQuantum employs its innovative LDC technology to develop novel bioconjugate drugs and has announced discovery partnerships with MITRO Biotech of Nanjing and Beijing's Biocytogen.

TAKE2 Health, a Hong Kong healthcare startup, in-licensed global rights to IP for an early nasopharyngeal cancer (NPC) test. The terms of the agreement were not disclosed. The IP was originally licensed to Grail, a US-Hong Kong spin-out from Illumina (NASDAQ:ILMN) that is developing early tests for cancer. Professor Dennis Lo, of the University of Hong Kong, developed the IP for the NPC test. Dr. Lo was once head of Grail and is now a co-founder of TAKE2. TAKE2 aims to make the most disruptive healthcare inventions widely accessible to the public in China and Asia.

WuXi AppTec (SHA: 603259; HK: 2359), China's largest CRO/CMO, acquired San Diego's Pharmapace, a clinical research service company offering biometrics services for all phases of clinical trials, regulatory submissions and post marketing support. Pharmapace will become a wholly-owned subsidiary of WuXi Clinical, the clinical CRO arm of WuXi AppTec. Founded in 2013, Pharmapace will focus on increasing its core biometrics competences while it integrates with WuXi Clinical's other clinical development services. Financial details were not disclosed.

Harbour BioMed will partner with Chia Tai Tianqing (CTTQ), a Lianyungang pharma, to discover and develop next-gen biologics for therapeutic targets in oncology and immunology. Harbour will use its discovery platform, including its transgenic mouse technology, to generate fully human antibodies, while CTTQ will contribute its preclinical development expertise. CTTQ will be responsible for clinical development of all candidates in China and the EU; Harbour will have rights to the US and the rest of the world. Each company will pay royalties on sales to the other.

Trials and Approvals

Innovative Cellular Therapeutics, a Maryland-Shanghai biotech, presented data from its ongoing clinical trial and preclinical studies of its lead candidate, ICTCAR014, a combination of anti-CD19 CAR-T cells with a dominant negative PD1 molecule. In preclinical tests, these "armored" CAR-T cells show enhanced ability to kill tumors and more "memory-like" phenotypes compared to conventional CAR-T cells, the company says. In a China trial, two patients treated with ICTCAR014 for refractory diffuse large B-cell lymphoma (DLBCL) experienced a significant decrease in tumor mass.

Connect Biopharma of Suzhou completed a successful Phase I single ascending dose trial of its novel IL-4Rα antibody, CBP-201. Connect is testing CBP-201 as a treatment for atopic dermatitis and other Th2 inflammatory diseases. The double-blind, placebo-controlled study, conducted in Melbourne, evaluated the safety, pharmacokinetics and pharmacodynamics of CBP-201 in 40 healthy adults. The company expects to post topline data from a Phase Ib CBP-201 trial, already underway, in late 2019.

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Editor's Note: The summary bullets for this article were chosen by Seeking Alpha editors.