Deals and Financings

I-Mab, a Phase III Shanghai immunoncology-autoimmune biopharma, announced the terms for its $100 million IPO on the NASDAQ exchange at a market value of $750 million (see story). The company plans to offer 7.4 million shares at a price that ranges from $12 to $15. Final pricing is expected on January 16. In addition, I-Mab has dosed the first patient in a registrational China Phase II trial of a CD38 antibody in patients with relapsed-refractory multiple myeloma (MM). In 2017, I-Mab in-licensed greater China rights to the antibody from Germany's MorphoSys (FSE: MOR).

Beijing's BeiGene (NSDQ: BGNE; HK: 06160) announced a $132 million collaboration with Leap Therapeutics (NSDQ: LPTX) of the US for Asia rights (excluding Japan) to Leap's anti-Dickkopf-1 (DKK1) antibody (see story). BeiGene intends to test DKN-01 as a treatment for various gastric cancers in combination with tislelizumab, its PD-1 molecule that was approved for use in China earlier this week. BeiGene paid $3 million for an option on the Asia rights, plus it will make a $5 million equity investment in Leap as part of a $27 million PIPE that also included two institutional investors.

Suzhou's CF PharmaTech, a company focused on providing high-quality and affordable inhalation products globally, raised $90 million in a Series E funding led by New Alliance Capital (see story). In 2017, CF completed a $65 million Series D round. The company is developing an expanding pipeline of over 20 products for China and global markets. Its four R&D delivery platforms include MDI, nasal spray, nebulizer and DPI. CF said the funding will allow it bring its products to commercialization. CF has built a manufacturing facility in Suzhou that is compliant with US, China and EU regulations.

MyGene Diagnostics of Guangzhou completed a $14 million Series B round to provide second-gen high throughput screening for clinical diagnostics and treatment guidelines of cancer (see story). Founded in 2015, MyGene provides individualized precision treatment guidance for cancer patients, including genetic risk assessment, early screening, individualized medication guidance and prognosis monitoring. The B round was led by Shenzhen Capital Group, an existing investor, and CASH Capital of Beijing. Great Wall Fund Management and Zhanglong Sanjun Venture Capital Investment also participated.

Xuanzhu (HK) Biopharmaceutical has agreed to acquire greater China rights to Zemdri, a novel anti-infective, from Achaogen of the US for $4.5 million (see story). Achaogon declared bankruptcy earlier this year. Zemdri (plazomicin), a treatment for multidrug-resistant, gram-negative pathogens, is approved in the US to treat complicated urinary tract infections, though it carries a black-box safety warning. At one point, Achaogen expected Zemdri would generate $500 million in sales as a promising treatment for drug-resistant pathogens. However, the FDA did not approve Zemdri as a treatment for bloodstream infections, sending the company into bankruptcy.

Trials and Approvals

BeiGene (NSDQ: BGNE; HK: 06160), a Beijing company developing targeted and immunoncology therapies, reported China has approved its anti-PD-1 antibody to treat classical Hodgkin’s lymphoma (see story). It is indicated for CHL patients who have received has received at least two prior therapies. In a China Phase II trial, tislelizumab produced an objective response rate of 77% and a 62 % complete response rate. The PD-1 molecule is BeiGene's first drug approved in China; earlier, the US approved Brukinsa, BeiGene's BTK inhibitor, for mantle cell lymphoma (MCL).

Clover Biopharma of Chengdu dosed the first patient in a China Phase III trial of SCB-808, an Enbrel® (etanercept) biosimilar, for patients with rheumatic diseases, including ankylosing spondylitis and rheumatoid arthritis (see story). Clover is developing SCB-808 in a prefilled syringe formulation, unlike the powder formulations of Embrel biosimilars currently approved in China. Also, the company's candidate is being tested under new China guidelines for biosimilars, which require head-to-head comparisons with the original drug. Formed in 2016, Clover develops novel biologics, using its trimer-tag technology, along with biosimilars.

Government and Regulatory

Jiankui He, the Shenzhen scientist who used CRISPR-Cas9 gene editing to alter the embryos of seven IVF patients, was sentenced to three years in prison and a fine of $430,000 (see story). Dr. He maintains he used gene editing to disable the CCR5 gene that allows HIV to enter cells. The researcher was accused of avoiding standard procedures for protecting patients in an attempt to become the first scientist to perform the procedure. Dr. He pleaded guilty and is banned for life from providing assisted reproductive services.

Disclosure: none.