Did you know?
ChinaBio® Group is a consulting and advisory firm helping life science companies and investors achieve success in China. ChinaBio works with U.S., European and APAC companies and investors seeking partnerships, acquisitions, novel technologies and funding in China.
Have the latest stories on China's life science industry delivered to your inbox daily or weekly - free!
Week in Review: AstraZeneca Announces $1 Billion Fund for China Life Science Startups
Deals and Financings
AstraZeneca (NYSE: AZN) announced plans to raise up to $1 billion to fund China life science startups (see story). The company will partner with China International Capital Corporation (CICC) to raise the capital, with reports that Sequoia China may also join. The fund plans to raise between $200 million and $300 million this year, and up to the full $1 billion over four years. AstraZeneca is already building a new China research center and an artificial intelligence lab, both in Shanghai, which it will expand to include the new biopharmas. The company will share its expertise with the startups and may choose to invest further in them.
BeiGene (NSDQ: BGNE; HK: 06160) of Beijing announced a $160 million agreement for China/Asia rights to an advanced preclinical cancer candidate from Seattle Genetics (NSDQ: SGEN) (see story). The candidate was not described, though Seattle Genetics said it expected to start clinical trials of the molecule in the first half of 2020. Seattle Genetics is known for its antibody drug conjugate cancer drugs. BeiGene will make up to $160 million in upfront and development milestone payments, plus pay royalties on sales.
Akeso Biopharma, a Zhongshan antibody company, closed a $150 million Series D round of financing led by Loyal Valley Capital, a private equity firm, and Sino Biopharm (HK:1177) (see story). AkesoBio is developing a portfolio of 18 mAbs that are in either CMC or clinical stages of development for indications in oncology, inflammation, autoimmune and cardiovascular diseases. The company has filed seven IND applications in China, and it has begun clinical trials on two of them. One year ago, Akeso completed a Series C led by Ally Bridge, though the company did not disclose the size of the earlier round.
Peijia Medical, a Suzhou interventional medical device maker, raised $100 million in a series C funding that was led by Matrix Partners China, which also led Peijia's A round (see story). Founded in 2012, Peijia claims to have developed China's first cardiovascular drug-eluting stent and intracranial embolization coil. Other investors in the C round included Lily Asia Ventures, SDIC Fund Management Company, Grand Flight Investment and Chengtong Fund. Peijia claimed the C round is one of the largest venture rounds on record for a China device maker.
Suzhou's Tot Biopharm (HK: 1875) completed a $66.5 million IPO on the Hong Kong Exchange to support development of its novel and biosimilar cancer drugs (see story). Tot's portfolio consists of seven biological and five chemical candidates, all but one of them developed in-house. Its products include mAbs, antibody drug conjugates (ADCs), oncolytic virus products and specialty oncology drugs such as liposome drugs. Tot's lead product is an Avastin biosimilar that is expected to launch in late 2020 or early 2021.
Sino Medical Sciences (SHA: 688108) completed an IPO on the Shanghai STAR Exchange last week, raising $50 million at a market capitalization of $412 million (see story). The company makes high-end novel interventional medical devices for cardiovascular needs. Its products include drug eluting stents, balloon catheters, coronary stents and transcatheter mitral valve replacement kits. SinoMed's stock price rose as much as 217% in its first trading day. Founded in 2007, the company's headquarters and other operations, including R&D and production, are located in Tianjin.
Genecast (Beijing) Technology closed a $43 million Series D financing to expand its non-invasive cancer diagnostic business (see story). Founded in 2014, Genecast has developed a circulating tumor DNA detection technology that provides individualized cancer diagnoses. The company offers oncology diagnostic products and services to China biopharmas, collaborating with more than 20 biopharmas and providing comprehensive pre-clinical and clinical testing services. The D round, which brings Genecast's total VC backing to $93.5 million, was led by CICC Capital.
Antengene, a Shanghai novel drug biopharma, has in-licensed global rights to a novel cancer treatment from AstraZeneca (NYSE: AZN) (see story). The company said AstraZeneca has filed an open IND application for AZD0364, a selective small molecule ERK1/2 inhibitor, in the US for multiple solid tumor cancers. ERK is a key component of the Ras-Raf-MEK-ERK (RAS/MAPK) pathway, which promotes tumor cell growth and survival. Antengene expects the candidate will be effective as a monotherapy and in combination with other of its portfolio drugs. Details of the agreement were not disclosed.
Simcere Pharma of Nanjing in-licensed greater China rights for a clinical stage drug that treats cerebral edema following stroke from Aeromics of New Haven, Connecticut (see story). AER-271 is a first-in-class IV prodrug that delivers an inhibitor of Aquaporin-4, a water channel protein that facilitates brain swelling after ischemic strokes. It has completed an Aeromics-led Phase I trial. Aeromics will receive an upfront payment and additional development, regulatory and commercial milestones, plus tiered royalties on net sales. Simcere already markets Bicun, an edaravone free-radical scavenger to prevent strokes.
Trials and Approvals
Shanghai Green Valley Pharma announced China approval of Oligomannate, a seaweed-based treatment for Alzheimer's disease that improves cognitive function (see story). In a China clinical trial, patients who received Oligomannate showed a mean gain of 2.54 in their ADAS-Cog12 Scores, a result that was consistent from the first month to the end of the treatment at nine months. Oligomannate, a low molecular acid oligosaccharide compound extracted from marine brown algae, is the first new treatment for Alzheimer's globally since 2003, and also one of the first approved drugs that works by modifying the gut microbiome. Green Valley will launch the drug in China before the end of 2019 and start global Phase III trials next year to support approval in the US, Europe and Asia.
Bio-Thera Solutions of Guangzhou was approved for a China launch of Qletli® (格乐立®), its biosimilar to autoimmune disease treatment Humira, the world's best selling drug (see story). Qletli, the first Humira biosimilar approved in China, will be indicated for the same three conditions as the original drug: rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis. Bio-Thera develops biosimilars and novel drugs for cancer, autoimmune and cardiovascular diseases. The company will also seek approvals for Qletli in other markets.
CANbridge, a Beijing oncology and rare disease biopharma, announced that Hong Kong approved Nerlynx® (neratinib) as an extended adjuvant treatment for HER2-overexpressed/amplified breast cancer (see story). Patients must have completed adjuvant Herceptin (trastuzumab) therapy within the last year. The company has also filed for approval of the drug in China based on the 2017 FDA acceptance of Nerlynx in the US. CANbridge in-licensed greater China rights to Nerlynx last year from Puma Biotech (NSDQ: PBYI) in a deal that included $70 million in upfront and development milestone payments.
Suzhou's CStone Pharma (HK: 2616) released positive results from a China Phase II trial of its PD-L1 candidate (CS1001) as a monotherapy in relapsed or refractory extranodal natural killer/T-cell lymphoma (rr-ENKTL) (see story). CS1001 produced an overall response rate of 41%, a complete and durable response rate of 32% and a benign safety profile. The company says studies have shown links between Epstein-Barr virus (EBV) infection and ENKTL. EBV infection induces immune tolerance by upgrading PD-L1 expression in tumor cells, promoting tumor growth. CStone is developing a pipeline of 15 oncology drug candidates.
Ark Biosciences, a Shanghai biotech, reported positive topline results from a Phase II proof-of-concept study of Ziresovir (AK0529) in infant patients with respiratory syncytial virus (RSV) infection (see story). The company said it was the first time an antiviral agent has successfully treated infants hospitalized with the infection. In its Phase II study, Ziresovir demonstrated a dose-dependent clinical efficacy, reducing patients’ signs and symptom scores along with their viral loads. Patients did not experience any safety issues. Ark plans to advance the antiviral into Phase III registration trials.
Harbour BioMed, a Boston, Rotterdam and Shanghai biopharma, started the first clinical trial of a next-gen anti-CTLA-4 antibody (HBM4003) in patients with advanced solid tumors (see story). The Australian trial is the first with a fully human antibody based on heavy chain only antibody technology (HCAb). The company said HBM4003 showed potent anti-tumor activity with lower systemic drug exposure in preclinical tests, potentially offering an improved therapeutic profile. The Australian trial will be followed by similar tests in China and the US.
Suzhou's Ascentage Pharma (HK: 6855) will collaborate with Henlius of Shanghai on a China trial that combines Ascentage's Bcl-2 inhibitor with Henlius' (HK: 2696) Rituxan (rituximab) biosimilar in patients with chronic lymphocytic leukemia (CLL) (see story). Ascentage's APG-2575 is the first China-developed Bcl-2 inhibitor to begin clinical trials, while Henlius' rituximab injection is the first China biosimilar approved for use. APG-2575 blocks Bcl-2 to restore apoptosis in hematologic cancers. Henlius' biosimilar is approved to treat CLL in China. One week ago, Ascentage completed its Hong Kong IPO, while Henlius staged a Hong Kong IPO in September.