Deals and Financings

Pharmaron Beijing (SHZ: 300759; HK: 3759) staged a $434 million Hong Kong IPO to expand its international CRO operations (see story). In January, Pharmaron completed a $76 million IPO on the Shenzhen Exchange, and its stock price has quadrupled since its debut. The company said the dual registration will support its growth plans, including developing its global integrated service platform, R&D capability, M&A and strategic investments. Founded in 2004, with facilities in China, the US and UK staffed by over 7,000 employees, Pharmaron offers R&D services to partners in North America, Europe, Japan and China.

Genetron, a Beijing-North Carolina genomics company, closed a $71 million Series D Round to develop cancer molecular diagnostics products and services (see story). The company's offerings include risk assessment, early screening, molecular pathology diagnosis, medication guidance and prognosis monitoring. Its products address the needs of cancer patients and high-risk groups as well as people who show no signs of disease. The company also works with biopharmas to discover biomarkers for precision medicine drugs. The funding was led by Vivo Capital, CICC Healthcare Investment Fund and Alexandria Venture Investments.

Sichuan Clover Biopharma completed a $43 million Series B round to support its biologic drug operations (see story). One week ago, Clover announced it had started a fifth trial of its lead drug, a TRAIL-Trimer fusion protein being tested for three indications in China and Australia. Clover intends to use the proceeds to develop biological candidates, operate its commercial-scale cGMP biomanufacturing facility and expand its R&D pipeline using the company's proprietary Trimer-Tag© technology platform. The financing brings Clover’s total capital raised since 2016 to over $100 million.

Shanghai Ennovabio Pharma, a novel drug startup, closed a $14 Series A financing led by Matrix Partners China and joined by existing shareholder Highlight Capital (see story). Established in 2016 in Shanghai's Zhangjiang Park, Ennovabio uses bioinformatics to develop Class 1.1 novel drugs. The company expects to file INDs in China and the US next year for its lead candidate, a treatment for diabetic eye disease. Ennovabio, which plans to combine internal research with in-licensed candidates to build its pipeline, has six novel drugs in preclinical development.

GensKey, a Beijing diagnostics company, raised $14 million in a B round to expand its pathogen diagnosis services in China (see story). Founded in 2017, GensKey uses next-gen sequencing technology to diagnose pathogens. Its lead product, GenseqPM, claims the ability to identify any pathogenic micro-organisms with a high rate of detection that is highly accurate and speedy. The company, a product of Peking University's incubator program, is headquartered in Changping Life Science Park in Zhongguancun, Beijing. The financing included SB China Capital, Shanghai Lin Chong Investment Management and Yuanju Capital.

Trials and Approvals

Merck/MSD (NYSE: MRK) announced Keytruda, its anti-PD-1 therapy, has been approved by China's NMPA as a first-line treatment for patients with metastatic squamous non-small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel (see story). It is the third China approval of Keytruda as a first-line NSCLC therapy in one year. Previously, Keytruda was approved in China with chemotherapy as a first-line treatment of squamous and nonsquamous NSCLC, as well as a monotherapy for NSCLC patients with PD-1 positive tumors. The latest approval was based on improvement in overall survival among China patients.

China Ophthalmology Focus Limited (COPFL) (HK: 0950)) of Guangzhou completed enrollment of its large Phase III trial of an Adapalene-Clindamycin Combination Gel in China in patients with severe acne vulgaris (see story). COPFL is a non-wholly owned subsidiary of Lee's Pharm that raised $50 million in a Series A round earlier this year. Through its subsidiary, Zhaoke, COFPL owns a development and production facility in Guangzhou that is developing a portfolio over 21 ophthalmology proprietary products and difficult-to-manufacture generics for China and ASEAN markets. The facility is compliant with all international standards.

Suzhou Innovent Biologics (HK: 01801) started the first clinical trial of a bispecific cancer treatment that targets PD-1 and HER2 (see story). Innovent developed the bispecific, IBI315, with Beijing Hanmi Pharma, a subsidiary of Korea's Hanmi, using Hanmi's PentambodyTM bispecific platform. Although IBI315 includes a PD-1 immunotherapy, Innovent does not identify it as Tyvyt®, the company's China-approved PD-1. According to Innovent, IBI315 blocks the PD-1/PD-L1 signaling pathway, the HER2 signaling pathway, and it is also thought to bridge PD-1-expressing T cells to HER2-expressing tumor cells.

Hutchison China MediTech (Chi-Med) (AIM/NSDQ: HCM) reported the US FDA has granted Orphan Drug designation to the company's surufatinib as a treatment for pancreatic neuroendocrine tumors (NET) (see story). Two weeks ago, China's NMPA accepted Chi-Med's surufatinib NDA for review to treat advanced non-pancreatic NET. Surufatinib, the second novel Chi-Med oncology drug to complete a China Phase III trial, is being tested in multiple solid tumors in China and the US, both as a monotherapy and in combination with immunotherapies. With US orphan drug status, surufatinib will be entitled to seven years of market exclusivity.

Disclosure: none.