Bio-Thera Solutions (SHA: 688177) of Guangzhou priced its IPO on Shanghai’s STAR Board to raise $241 million at a valuation of almost $2 billion (see story). The offering, which placed 60 million shares at RMB32.76 each, was reported to be 3,225 times oversubscribed. Bio-Thera lists ten antibody candidates in its pipeline. The company develops novel antibodies (6) and biosimilars (4) for oncology and autoimmune indications. In January, the company's Humira biosimilar was approved for China use, its first commercialization approval.

Shanghai Universal Medical Imaging Diagnostic company closed an $86 million Series B round to support its China third-party imaging centers that it partners with hospitals (see story). So far, the company has established centers in Shanghai, Hangzhou, Guangzhou, Chongqing and Tianjin, and it plans to add another five centers by the end of 2020. The B round was led by a CEC Capital-owned private equity fund, Cathay Capital, along with V Star Capital, an investment management spinoff from GGV Capital.

Stilla Technologies, a Paris company developing a PCR device that detects and quantifies DNA mutations, completed a $22 million Series B round with a new China investor, TUS-Holdings, participating (see story). TUS-Holdings is associated with Tsinghua University and the Tsinghua Science Park in Nanjing. An incubator, it has $30 billion in capital under management. The head of TUS' European subsidiary, Daniel Wang, will join the Stilla board. Stilla said that the relationship will extend its presence in China, which is already established through a partnership with Apexbio/Cycloud.

Beijing Advaccine Biotechnology raised $4.3 million in a new funding that will be used to test a coronavirus (2019-nCoV) vaccine (see story). Two weeks ago, Advaccine and Inovio of the US announced a partnership to develop a coronavirus vaccine, with Inovio receiving a $9 million grant from the Coalition for Epidemic Preparedness Innovations (CEPI) to underwrite the work. Advaccine will be in charge of Phase I China testing that will parallel Inovio's. Advaccine expects to complete China preclinical development of the vaccine in 4 to 6 months and then apply for clinical testing approval.

Wuhan Coronavirus Outbreak

BrightGene Bio-Medical (SHA: 688166) of Suzhou has synthesized the API of remdesivir, a Gilead (Nasdaq: GILD) drug that has started China Phase III trials to treat patients infected with the COVID-19 virus (see story). Gilead owns IP on the drug, so the announcement produced worry that BrightGene may infringe on Gilead's patent. BrightGene said it already has mass-produced remdesivir's API and is in the process of turning it into finished doses. The company further declared it intends to license the drug from Gilead, though it isn't clear that any negotiations have begun.

Sihuan Pharma (HKEX: 0460) and Hetero Labs, an Indian generic drug maker, have signed a framework cooperation agreement to bring Hetero's products -- including potential COVID-19 anti-infectives -- to China (see story). Hetero claims to be the leading producer of anti-retroviral drugs for HIV/AIDS, serving 40% of the HIV/AIDS population globally with 30 anti-retroviral product combinations. Sihuan, a novel drug company, will make and distribute Hetero's generic products in China.

Johnson & Johnson (NYSE: JNJ), through its Janssen subsidiary, will collaborate with a US government agency, the Biomedical Advanced Research and Development Authority (BARDA), to expedite development of a coronavirus vaccine (see story). BARDA will provide funding to bring a candidate into Phase I clinical studies, with further support possible. Previously, Janssen developed a vaccine for Ebola, a similar infection to COVID-19, as well as vaccine candidates for Zika, RSV and HIV. J&J is also working with global partners to screen its library of antiviral molecules to discover other potential candidates for COVID-19.

Clover Bio of Chengdu has produced a trimeric Spike-protein (S-Trimer) subunit vaccine candidate for the Wuhan coronavirus via a mammalian cell expression system (see story). Clover scientists have also used the newly obtained S-Trimer to detect antigen-specific antibodies in sera from recovered 2019-nCoV patients. According to the company, it is the first biopharma to disclose a 2019-nCoV vaccine candidate that can be recognized by antibodies produced in previously-infected patients.

Trials and Approvals

Roche (SIX: ROG) announced China approval to launch its PD-L1 immunotherapy, Tecentriq (atezolizumab) (see story). Tecentriq is approved in combination with chemotherapy (carboplatin and etoposide) as a a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). Roche noted the China approval came less than a year after Tecentriq was approved in the US and EU. One month ago, the China NMPA also accepted for review a supplemental Tecentriq BLA in combination with Avastin to treat unresectable hepatocellular carcinoma.

Genetron Holdings of Beijing received NMPA approval to launch its 8-gene Lung Cancer Assay along with a high-throughput NGS platform, the GENETRON S2000 (see story). Genetron, a precision oncology diagnostics company, said the new assay is fast and easy-to-use with a One-Step Seq technology suited for high-throughput clinical testing centers such as large hospitals and regional medical testing centers. Genetron's services include risk assessment, early screening, molecular pathology diagnosis, medication guidance and prognosis monitoring. The company has raised $132 million in C and D rounds over the last two years.

Samsung Bioepis, a biosimilar JV formed by Korea's Samsung and US-based Biogen, will start a China Phase III trial of a biosimilar to Soliris (eculizumab), a treatment for paroxysmal nocturnal hemoglobinuria (PNH) (see story). PNH is a rare genetic disease that affects stem cells causing them to produce defective blood cells. It usually strikes people between the ages of 35 and 40. Samsung Bioepis, which is conducting a global Phase III test of SB12, partnered China rights to eculizumab with AffaMed Therapeutics. AffaMed was formed by C-Bridge Capital to bring Samsung Bioepis biosimilars to China.

Zai Lab (Nasdaq: ZLAB) reported China's NMPA has accepted for review its NDA for omadacycline, an anti-infective (see story). Omadacycline is a proposed treatment for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). Developed by Paratek Pharmaceuticals of the US, omadacycline (Nuzyra®) is a novel tetracycline, designed to overcome tetracycline resistance. It has been available in the US since 2018. To acquire China rights to the anti-infective, Zai paid $7.5 million upfront and agreed to a package of unspecified milestones, plus royalties.