Deals and Financings
RemeGen (HK: 9995), a Yantai biotech approaching commercial stage, completed a $515 million IPO on the Hong Kong exchange in the largest biotech IPO of the year. Founded in 2008, RemeGen is developing a portfolio of ten novel mAbs, fusion proteins, antibody-drug conjugates (ADCs) and bifunctional antibodies. Two of its candidates are under NDA review in China: telitacicept for autoimmune diseases (systemic lupus erythematosus) and disitamab vedotin for HER2 cancers. The company’s shares have traded 34% higher since the IPO, giving RemeGen a market capitalization of $4.3 billion.
Ambrx, a San Diego antibody conjugate biopharma owned by China investors, completed an oversubscribed $200 million crossover financing. The company uses an expanded genetic code to incorporate synthetic amino acids into protein, all completed within a living cell. Ambrx says the process creates a new class of therapeutics including next-gen ADCs, bispecifics, and targeted immuno-oncology therapies for cancer, plus smart cytokines for the immune system and therapeutic peptides for metabolic and cardiovascular disease. In 2015, Ambrx was acquired by Fosun Pharma (SHA: 600196; HK: 02196) and WuXi AppTec (SHA: 603259; HK: 2359), plus China equity investors HOPU and Everbright.
Pharmaron Beijing (SHZ: 300759; HK: 3759), a CRO/CMO, acquired Absorption Systems of Philadelphia in a deal work up to $137.5 million. Absorption Systems is a non-clinical CRO that provides research and testing for small and large molecules, cell and gene therapies, ocular and medical device products. It has facilities in Philadelphia, San Diego and Boston. Pharmaron, which offers laboratory, CMC and clinical development services, said the acquisition will increase its global services.
China’s Tencent (OTCPK:TCEHY) co-led a $50 million C round for Congenica, a Cambridge UK genomic analysis company. Congenica’s products enable rapid, accurate analysis of complex genomic data, especially for genomic analysis of rare diseases and inherited cancers. With the new funds, the company plans to expand into somatic cancer and wellness. Tencent, a China internet company, has an online healthcare subsidiary, Trusted Doctor, but the company did not say whether it expects to incorporate Congenica into its online services.
Shanghai Zhimeng Biopharma closed a $35 million Series A round to support clinical trials of its novel hepatitis B virus nucleocapsid inhibitor and other products. Zhimeng started a US-based Phase I dose escalation study of ZM-H1505R, its lead HBV therapy, earlier this year. Zhimeng develops treatments for chronic hepatitis B infection and CNS therapies for stroke, epilepsy and other neurological disorders. The A round was led by Trinity Innovation Fund and included SDIC, Oceanpine Healthcare Fund and Photon Fund.
Inmagene Biopharma of Shanghai closed a $21 million Series B financing, led by Vertex Ventures China for immunology-related therapies. The company will use the proceeds to conduct global clinical trials, R&D and product in-licensing activities. Its lead product, IMG-02, is a very small protein drug with high affinity to IL-17A being tested as a psoriasis therapy in a Phase II trial. Inmagene in-licensed Greater China rights to IMG-02 from Affibody SE of Sweden in a $225 million deal.
HitGen (SHA: 688222) of Chengdu out-licensed China rights for its Trk/ROS1 inhibitor to Guangzhou Baiyunshan Pharma (SHA: 600332; HK: 00874). Baiyunshan will pay $6 million upfront and be responsible for milestone and royalty payments, though details were not disclosed. HitGen discovered HG030, a novel second-gen Trk/ROS1 inhibitor, using its DNA-encoded chemical libraries (DELs) platform. In March, China’s NMPA approved the company’s IND for the inhibitor to treat patients with NTRK/ROS1 gene fusion-positive cancers.
Innoforce, a Hangzhou company, formed a JV with Thermo Fisher Scientific (NYSE:TMO) to build a large biologics and steriles drug development and manufacturing facility in the Hangzhou Airport Economic Demonstration Area. Innoforce describes itself as a CDMO and a partnership development and manufacturing organization (PDMO) that provides venture management expertise, product development guidance and equity investment to select partners. For Thermo Fisher, the JV offers its ex-China customers access to China product development and its market.
Decheng Capital had good reason to be pleased when Merck (NYSE:MRK) paid $2.75 billion to acquire VelosBio, a company formed in 2017 to develop ROR1 ADCs for cancer. In an exclusive interview, Min Cui, PhD, Founder and Managing Director of Decheng, told ChinaBio Today, “We are VelosBio’s largest shareholder because we backed the company from day one. It’s a huge win for us and all the stakeholders, including Merck and cancer patients. We were the original firm who led VelosBio’s seed funding and participated in the A round and the recent $137 million B funding. We were ready to IPO, but Merck decided they wanted to own the company.”
Genscript USA, a division of China-headquartered Genscript Biotech (HK: 1548) (OTC:GNNSF), reported its cPass SARS-CoV-2 Neutralization Antibody Detection Kit was approved in the US under Emergency Use rules. According to the company, it is the first commercially available test that can specifically detect neutralizing antibodies without the use of live virus. The test measures neutralizing antibodies in any sample, including individuals recovering from COVID-19 or vaccinated against SARS-CoV-2. The test provides results in one hour.
Fosun Pharma’s (SHA: 600196; HK: 02196) in-licensed COVID-19 vaccine reported 90% efficacy in US-EU Phase III tests, which were conducted by Pfizer (NYSE:PFE) and Germany’s BioNTech (NASDAQ:BNTX). In March, Fosun acquired China rights to the vaccine from BioNTech in a $135 million agreement. Pfizer acquired US rights soon after. Pfizer said it would apply for US Emergency Use approval in about three weeks. To acquire the vaccine rights, Fosun made a $50 million investment in BioNTech (which has since tripled) and will pay up to $85 million in milestones.
Trials and Approvals
Suzhou CStone Pharma (HK: 2616) (OTCPK:CSPHF) reported China’s NMPA accepted for review its NDA for sugemalimab, an anti-PD-L1 mAb, as a first-line therapy for non-small cell lung cancer. The regimen combines sugemalimab with chemotherapy for advanced squamous and non-squamous forms of NSCLC. It is the first NDA for the anti-PD-L1 candidate submitted by CStone worldwide, the sixth CStone NDA worldwide, and its third China submission this year. CStone develops novel immunoncology therapies and precision medicines.
Beijing’s BeiGene (NSDQ: BGNE; HK: 06160) reported that China regulators will review its BLA for a novel neuroblastoma therapy. Qarbiza (dinutuximab beta) is a targeted immunotherapy approved in the EU to treat high-risk neuroblastoma in patients aged 12 months and above. High-risk neuroblastoma, an aggressive neoplasm, is the most common childhood solid tumor that originates outside of the brain. BeiGene in-licensed China rights to dinutuximab beta from EUSA, a company that operates in the US and EU.
Calliditas Therapeutics (NASDAQ:CALT) of Sweden announced positive topline results from a global Phase III trial that tested Nefecon as a treatment for a rare disease, primary IgA nephropathy (IgAN). China’s Everest Medicines (HK: 1952) announced a $121 million agreement to acquire China rights for Nefecon in 2019. In September of this year, Everest joined the global Phase III trial, NefIgArd, which is testing Nefcon. With two million estimated patients, IgAN has a higher prevalence in China than in western countries.
Shanghai’s I-Mab (NASDAQ:IMAB) reported positive initial results from a US Phase I trial of its CD47 treatment for relapsed or refractory solid tumors and lymphoma. The candidate, lemzoparlimab, was designed to lessen the toxicity of CD47 drugs by avoiding binding to red blood cells. In the trial, lemzoparlimab was well tolerated without dose-limiting toxicity or anemia. Next, it will be tested in combination with other drugs. In September, I-Mab announced a nearly $2 billion global partnership with AbbVie (NYSE:ABBV) for lemzoparlimab.
Apollomics, a Foster City, CA-Hangzhou biopharma, was approved to start a Phase I trial of a novel treatment for solid cancers in China. APL-102 is an oral, multi-kinase inhibitor targeting several oncogenic drivers, including receptor tyrosine kinase, serine/threonine-kinases and platelet-derived growth factor receptors. Apollomics discovered and developed the candidate itself. Last week, Apollomics, which was incubated by OrbiMed, announced it has completed a $124 million Series C financing.
Editor’s Note: The summary bullets for this article were chosen by Seeking Alpha editors.