China’s I-Mab Biopharma just raised a massive $220 million in a third-round fundraising that once again reveals the growing strength of the country’s emerging biotech sector.
The Shanghai-based company—which grew out of the merger between Third Venture Biopharma and Tasgen Biotech last year—says it plans to plow the cash back into its pipeline of preclinical and clinical-stage antibody drugs for cancer and autoimmune disorders. It’s had no difficulty raising cash to fund its endeavors, having completed a $150 million series B round in March 2017.
I-Mab will need plenty of cash if it to pursue its strategy of taking multiple programs through the clinic simultaneously. It has already filed for approval to start trials of several drug candidates in China and the U.S., including multiple phase 2 and phase 3 studies, with more on the way.
Last year, I-Mab boosted its pipeline by licensingMorphoSys’ anti-CD38 antibody MOR202—a potential rival to Johnson & Johnson’s multiple myeloma drug Darzalex—in China and neighboring territories for $120 million. It also licensed Chinese rights to interlukin-7 candidate HyLeukin from South Korean biotech Genexine in a deal reported to be worth $548 million, including $12 million upfront.
The company has a two-pronged approach to R&D, with one portion of its pipeline directed at the domestic Chinese market and a second focusing on therapies for the U.S. and other international markets.
“This round of financing will facilitate further development of our innovative assets in China and internationally,” said Jingwu Zang M.D., Ph.D., the founder and CEO of I-Mab.
The scale of the fundraising is a measure of just how far China’s biotech industry has come in recent years. The country is reported to be already conducting more clinical trials than the U.S. and is pushing hard to develop advanced new therapies including CAR-T. Last year, a CAR-T candidate for multiple myeloma from Legend Biopharma was a surprise hit at ASCO.
There are already warnings that the China’s biotech sector could be getting overheated. In a recent ChinaBio Group article, Jonathan Wang of OrbiMed Asia suggested there is “a big bubble forming right now [and] a few companies have raised financings or are planning IPOs at overly high valuations, compared to their counterparts in other markets, such as the U.S.”
On the other hand, Wang sees “a very real, unprecedented boom in China’s biopharma industry, triggered by the CFDA reform, the influx of returnees to China, the high interest of investors and the establishment of new exit channels.”
I-Mab’s series C was led by Hony Capital, with Hillhouse Capital, HOPU Investments, CDH Investment, Ally Bridge Group, Singapore-based EDBI, and existing investors C-Bridge Capital and Tasly Capital also participating.
Independent mitochondrial DNA specialist Stealth BioTherapeutics has raised $100 million from Nan Fung Technology’s Pivotal Beta and other new and existing investors.
Chief executive Reenie McCarthy said: “We particularly welcome our new investors’ deep experience within the China healthcare market, which we view as an important frontier both for rare mitochondrial diseases under China’s recent rare disease initiative, as well as for diseases of aging.”
The money will finance a Phase IIb trial of Stealth’s lead compound, elamipretide, in intermediate dry age-related macular degeneration (AMD), for which positive interim results were recently reported and full results are expected later in 2018.
Elamipretide is currently in a Phase III clinical trial in mitochondrial myopathy and a Phase II/III trial in Barth syndrome. The firm says it will also ramp up regulatory and commercial preparation for the candidate in these indications.
The candidate has US Fast Track and Orphan Drug designations for these mitochondrial diseases, as well as for Leber’s hereditary optic neuropathy (LHON).
Nuance Biotech, a China-based specialty pharmaceutical company, today announced series B fundraising of US$20 million with additional capital US$15 million tied to its acquisition of new products, led by C-Bridge Capital, a private equity firm focused on Chinese healthcare market.
Shanghai-based Nuance Biotech was co-founded by Shao Yibo, a managing partner at Matrix Partners China and also co-founder of parenting community Babytree, and Mark Lotter, an industry veteran who built the commercial operations for multinational pharmaceutical firm AstraZeneca in China, in 2014.
The firm focuses on commercial, regulatory and development stage assets. It has built a portfolio that includes products that are already commercialized or in registration with the China Food and Drug Administration, along with a pipeline of drug candidates in clinical development.
“This investment represents a unique funding model for building a best-in-class pharmaceutical business in China,” said Fu Wei, CEO of C-Bridge Capital. “Nuance’s proven ability to move products through registration to the market along with its large sales organization and robust sales effectiveness system make it an excellent partner for commercializing innovative pharmaceutical products in China.”
With the investment, Neo Zhang, managing director of C-Bridge Capital, will join the board of Nuance.
In May 2017, the firm received US$8 million series A round from Matrix Partners China.
Shanghai-headquartered C-Bridge Capital focuses on middle and late-stage growth and buyout investment opportunities in China, including the pharmaceutical, medical technology and healthcare services sub-sectors. It has US$1.5 billion asset under management.
CAMBRIDGE, Mass. and SUZHOU, China, June 4, 2018 /PRNewswire/ — Blueprint Medicines Corporation (NASDAQ:BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, and CStone Pharmaceuticals, a privately-held biopharmaceutical company devoted to developing a new generation of innovative drugs, today announced an exclusive collaboration and license agreement for the development and commercialization of avapritinib, BLU-554 and BLU-667 in Mainland China, Hong Kong, Macau and Taiwan, either as monotherapies or combination therapies. Discovered and developed by Blueprint Medicines, avapritinib, BLU-554 and BLU-667 are potent and highly selective investigational kinase medicines that have each demonstrated clinical proof-of-concept in genomically defined subsets of patients with cancer. Blueprint Medicines will retain all rights to the licensed products in the rest of the world.
The collaboration strengthens CStone Pharmaceuticals’ portfolio with exclusive rights in the territory to three clinical-stage targeted therapies and expands Blueprint Medicines’ global efforts to address patient populations with high unmet needs. CStone Pharmaceuticals will lead clinical development of the licensed products in the territory by leveraging its regulatory expertise and broad local network, with the goal of commercializing the licensed products in the territory either as monotherapies or combination therapies. In addition, the companies plan to initiate a proof-of-concept clinical trial in China evaluating BLU-554 in combination with CS1001, a clinical-stage anti-programmed death ligand-1 (PD-L1) immunotherapy being developed by CStone Pharmaceuticals, as a first-line therapy for patients with hepatocellular carcinoma (HCC).
“Founded by seasoned executives with deep global and regional development experience and with a growing portfolio of potentially complementary cancer therapies, CStone Pharmaceuticals is an ideal partner in China,” said Jeff Albers, Chief Executive Officer of Blueprint Medicines. “With recent regulatory reforms in China and the emergence of innovative companies like CStone Pharmaceuticals, we believe this forward-looking collaboration has the potential to expand our ability to address significant patient needs in Greater China while supporting global development of avapritinib, BLU-554 and BLU-667. In particular, we are excited to announce the expansion of the BLU-554 clinical development program in China, where more than half of all new cases of hepatocellular carcinoma worldwide occur each year.”
“We are thrilled to enter into this collaboration with Blueprint Medicines, a leader in the discovery and development of highly selective kinase medicines, as the first step in a potentially long-term strategic partnership,” said Frank Jiang, Chief Executive Officer of CStone Pharmaceuticals. “Based on the compelling clinical data reported to date, we believe Blueprint Medicines’ targeted therapies – avapritinib, BLU-554 and BLU-667 – hold promise for dramatically altering the treatment landscape for patients in China with gastrointestinal stromal tumors, hepatocellular carcinoma, non-small cell lung cancer and other cancers. In addition, our rich pipeline of investigational cancer medicines enables exploration of combination treatment approaches with the potential to further improve patient outcomes worldwide.”
Subject to the terms of the agreement, Blueprint Medicines will receive an upfront cash payment of $40.0 million and will be eligible to receive up to approximately $346.0 million in potential milestone payments, including $118.5 millionrelated to development and regulatory milestones and $227.5 million related to sales-based milestones. In addition, CStone Pharmaceuticals will be obligated to pay Blueprint Medicines tiered percentage royalties on a licensed product-by-licensed product basis ranging from the mid-teens to low twenties on annual net sales of each licensed product in the territory, subject to adjustment in specified circumstances.
Pursuant to the terms of the agreement, CStone Pharmaceuticals will be responsible for conducting all development and commercialization activities in the territory related to the licensed products. In addition, CStone Pharmaceuticals will be responsible for costs related to the development of the licensed products in the territory, other than specified costs related to the development of BLU-554 as a combination therapy in the territory that will be shared by the companies.
Avapritinib is an orally available, potent and highly selective inhibitor of KIT and PDGFRα. Preclinical data have shown that avapritinib is active across a broad spectrum of KIT and PDGFRα mutations, including KIT D816V, PDGFRα D842V and KIT exon 17 mutations, for which there are limited or no effective treatment options. Blueprint Medicines is initially developing avapritinib, an investigational medicine, for the treatment of patients with advanced gastrointestinal stromal tumors (GIST) and advanced systemic mastocytosis.
In June 2017, avapritinib received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with unresectable or metastatic GIST harboring the PDGFRα D842V mutation. Previously, the FDA granted orphan drug designation and fast track designation to avapritinib. In addition, the European Commission has granted orphan drug designation to avapritinib. In May 2018, Blueprint Medicines announced plans to submit a New Drug Application to the FDA for avapritinib for the treatment of PDGFRα D842V-driven GIST in the first half of 2019.
BLU-554 is an orally available, potent, irreversible inhibitor of FGFR4. BLU-554 was specifically designed by Blueprint Medicines to inhibit FGFR4 with exquisite selectivity, thereby sparing the paralogs FGFR1, FGFR2 and FGFR3. Blueprint Medicines is developing BLU-554, an investigational medicine, for the treatment of patients with FGFR4-activated HCC. Blueprint Medicines estimates that approximately 30 percent of patients with HCC have tumors with aberrantly activated FGFR4 signaling. The FDA has granted orphan drug designation to BLU-554.
BLU-667 is an orally available, potent and highly selective inhibitor designed to target RET fusions, mutations and predicted resistance mutations. Blueprint Medicines is developing BLU-667, an investigational medicine, for the treatment of patients with RET-altered non-small cell lung cancer (NSCLC), medullary thyroid cancer and other solid tumors. BLU-667 was discovered by Blueprint Medicine’s research team leveraging its proprietary compound library. The FDA has granted orphan drug designation to BLU-667.
CS1001 is an investigational monoclonal antibody directed against PD-L1 being developed by CStone Pharmaceuticals. Authorized by the U.S.-based Ligand Corporation, CS1001 is a monoclonal antibody developed by the OMT transgenic animal platform, which can generate fully human antibodies in one step. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors natural G-type immune globulin 4 (IgG4) human antibody, which could reduce the risk of immunogenicity and potential toxicities in patients, a unique advantage over similar drugs.
A first-in-human Phase I study (CS1001-101) has been conducted by CStone Pharmaceuticals since October 2017 to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS1001 in patients with advanced tumors in China. The Phase Ia (dose escalation) portion was completed in May 2018, and the Phase Ib (dose expansion) portion has recently started patient recruitment. In parallel, several pivotal studies are underway, including tumor types with high incidence and prevalence rates in China.
About Blueprint Medicines
Blueprint Medicines is developing a new generation of targeted and potent kinase medicines to improve the lives of patients with genomically defined diseases. Its approach is rooted in a deep understanding of the genetic blueprint of cancer and other disease driven by the abnormal activation of kinases. Blueprint Medicines is advancing multiple programs in clinical development for subsets of patients with gastrointestinal stromal tumors, hepatocellular carcinoma, systemic mastocytosis, non-small cell lung cancer, medullary thyroid cancer and other advanced solid tumors, as well as multiple programs in research and preclinical development. For more information, please visit www.blueprintmedicines.com.
About CStone Pharmaceuticals
CStone Pharmaceuticals is a clinical stage biopharmaceutical company devoted to the development of innovative drugs. With a broad pipeline, the company engages in the development of cancer therapeutics with a special focus on immuno-oncology based combination therapies. All members of the management team are seasoned executives from top multinational pharmaceutical companies. CStone has successfully built up its core competency in clinical development and translational medicine. The company is backed by prestigious VC/PE funds via two financing rounds to date, raising $150 million in a Series A round in July 2016, followed by $260 million in a Series B round in May 2018. With an experienced team, a rich pipeline, a robust R&D model, and substantial funding, CStone is well positioned as the partner of choice for multinational pharmaceutical / biotech companies to develop drugs in China and the Asia-Pacific region. For more information about CStone Pharmaceuticals, please visit: www.cstonepharma.com
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the collaboration and license agreement between Blueprint Medicines and CStone Pharmaceuticals, including anticipated milestone and other payments under the collaboration; expectations regarding Blueprint Medicines’ ability to expand its programs for avapritinib, BLU-554 and BLU-667 globally and in the territory; the potential benefits of Blueprint Medicines’ or CStone Pharmaceuticals’ current and future drug candidates, whether as a monotherapy or combination therapy, in treating patients, including patients in the territory; expectations regarding the impact of current or future regulatory reforms in the territory; plans and expectations regarding combination treatment approaches with CStone Pharmaceuticals’ current or future drug candidates; plans and timelines for expanding Blueprint Medicines’ ongoing Phase 1 clinical trial for BLU-554 to the territory; plans and timelines for initiating a proof-of-concept clinical trial in China evaluating BLU-554 in combination with CS1001 as a first-line therapy for patients with HCC; expectations regarding Blueprint Medicines’ global efforts to address patient populations with high unmet needs; and Blueprint Medicines’ strategy, business plans and focus. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks and uncertainties related to the delay of any current or planned clinical trials or the development of Blueprint Medicines’ drug candidates, including avapritinib, BLU-554, BLU-667 and BLU-782; Blueprint Medicines’ advancement of multiple early-stage efforts; Blueprint Medicines’ ability to successfully demonstrate the safety and efficacy of its drug candidates; the preclinical and clinical results for Blueprint Medicines’ drug candidates, which may not support further development of such drug candidates; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials; Blueprint Medicines’ ability to develop and commercialize companion diagnostic tests for its current and future drug candidates, including companion diagnostic tests for BLU-554 for FGFR4-driven HCC, avapritinib for PDGFRα D842V-driven GIST and BLU-667 for RET-driven NSCLC; the success of Blueprint Medicines’ current and future collaborations, including its cancer immunotherapy collaboration with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. and its collaboration with CStone Pharmaceuticals. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Blueprint Medicines’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, as filed with the Securities and Exchange Commission (SEC) on May 2, 2018, and any other filings that Blueprint Medicines has made or may make with the SEC in the future. Any forward-looking statements contained in this press release represent Blueprint Medicines’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Blueprint Medicines explicitly disclaims any obligation to update any forward-looking statements.
By Angus McNeice | chinadaily.com.cn | Updated: 2018-06-06 01:05
A British company that has developed a robot that performs surgery has raised $100 million in funding from five investors including the Zhejiang SilkRoad Fund in China.
Cambridge-based CMR Surgical has created the world’s smallest surgical robot, called Versius, that performs laparoscopy, or “keyhole” surgery, with mechanical arms that mimic the movements of the human hand.
Zhejiang SilkRoad Fund, a fund set up by the Zhejiang provincial government in 2016, is investing in CMR for the first time, while the four other investors – Escala Capital Investments, LGT, Cambridge Innovation Capital and Watrium– had previously contributed to an earlier funding round that garnered $46 million.
The latest funds will go toward obtaining regulatory approval in the United States and Europe and taking the robot to market.
Surgeons have used robots to assist in keyhole surgeries for decades, however Versius is capable of tackling surgeries at an unprecedented rate, according to CMR technical director Luke Hares.
“The idea was to increase utilization – to make a device you can use three or four times a day, every day,” Hares said. “That compares to current systems that are used on average once every other day.”
Laparoscopic surgery is preferred to open surgery in many cases because it is less painful, involves fewer complications and requires shorter recovery time for patients.
During manual laparoscopy, a surgeon makes one or more small incisions in the abdomen and inserts a tube containing special surgical tools and a tiny camera, which is linked to a screen.
Uptake levels for keyhole surgery are low in most countries as the procedure is complicated and requires huge amounts of surgical training.
“You’re sort of operating with a long knitting needle through a pivot point, so up is down and down is up,” Hares said. “It’s incredibly difficult.”
A report published in March by the London-based Office of Health Economics estimated that 1.35 million patients in the United Kingdom were eligible for keyhole surgeries in 2016 and 2017.” Only 24 percent of those patients received manual keyhole surgery, while 1 percent received robotic keyhole surgery, and the rest underwent open surgery.
“There aren’t enough surgeons who can do it, and those who can aren’t able to do as many of the procedures as they’d like to do,” Hares said.
“When you move to a robotic solution, moving instruments is simple because the robot moves along with the surgeon’s hands in the same direction,” he added. “We make the whole thing much easier.”
Versius is thought to be the world’s smallest surgical robot and can be moved around a hospital and assembled for use in under half an hour. Most other designs are bulky and often remain in operating rooms, leading to long waiting lists for their use.
Hares said that surgeons need around three days of training to master the device. This includes learning some of the toughest tasks in keyhole surgery, like tying knots. Surgeons take around 30 hours of training to learn how to tie knots in manual keyhole surgery, whereas with Versius the training period is cut down to 30 minutes.
Hares said operating the device is similar to playing a video game – the surgeon sits in a chair and looks at a screen while maneuvering the robot arms using handheld controls.
CMR aims to bring Versius to market in the US and Europe by the beginning of next year and hopes to go on sale in China in around two years.
“We are taking baby steps in finding the right way to market and sell the system in China, and this investment might be the start of that,” Hares said. “The Chinese medical device regulation process is quite possibly the toughest in the world, so it will take us time.”
SHANGHAI, China and CAMBRIDGE, United Kingdom, May 30, 2018 (GLOBE NEWSWIRE) — Zai Lab Limited (NASDAQ:ZLAB), a Shanghai-based innovative biopharmaceutical company, and Crescendo Biologics Ltd (Crescendo Biologics), the developer of multi-functional biologics, announced today an exclusive, worldwide licensing agreement under which Zai Lab will develop, commercialize, and manufacture a topical, innovative antibody VH domain therapeutic for potential application in inflammatory indications. Crescendo Biologic’s product candidate was developed using Crescendo’s transgenic platform, which generates novel small, robust, and potent protein therapeutics based on fully human VH domain building blocks. Zai Lab anticipates filing an IND for this therapeutic candidate for clinical studies in psoriasis in 2019.
“Biologics-based therapies are increasingly effective in psoriasis and other skin conditions, but are often associated with treatment-limiting immunosuppressive side effects,” commented Harald Reinhart, M.D., Chief Medical Officer, Autoimmune and Infectious Diseases at Zai Lab. “We see a clear benefit with topically administered dermatologic preparations which offers strong clinical efficacy and potentially safer for chronic administration.”
Peter Pack, CEO of Crescendo Biologics, commented, “We are pleased to sign this agreement with Zai Lab, a foremost developer of innovative medicines across diverse therapeutic areas where there are substantial unmet needs in global markets. We’re delighted with the pace and efficiency of Zai Lab’s plan to develop clinical proof of concept with our Humabody®. Crescendo Biologics is dedicated to advancing therapies with enhanced efficacy and improved safety profiles, and we believe there are significant synergies for our approach with the Zai Lab pipeline of autoimmune programs.”
Under the terms of the agreement, Crescendo Biologics has granted to Zai Lab a worldwide exclusive license to develop and commercialize its drug candidate for all indications. Zai Lab will be responsible for conducting all regulatory filings, clinical studies, and commercialization activities, with both companies participating in a Joint Development Committee. Zai Lab has made an upfront cash payment to Crescendo Biologics and will provide development, regulatory, and commercial milestones for multiple indications. Crescendo Biologics will also be eligible to receive tiered royalties on global sales.
About Crescendo Biologics
Crescendo Biologics is a biopharmaceutical company developing potent, truly differentiated Humabody® therapeutics in oncology with a proprietary pipeline focus on innovative targeted T-cell approaches.
At the heart of its proprietary pipeline, Crescendo Biologics has developed CB307, a novel bispecific PSMA-targeted T-cell engager for the selective activation of tumour-specific T-cells exclusively within the tumour microenvironment, thereby avoiding systemic toxicity. This highly modular format can be re-configured to create a pipeline of multiple therapeutic candidates each treating a different cancer indication, by targeting any of a range of alternative tumour-specific markers.
The Company’s ability to develop multi-functional Humabody® therapeutics is based on its unique, patent protected, transgenic mouse platform generating 100% human VH domain building blocks (Humabody® VH). These robust molecules can be configured to optimally engage therapeutic targets delivering novel biology and superior biodistribution. This results in larger therapeutic windows compared to conventional IgG-approaches.
Crescendo Biologics is pursuing novel Humabody®-based product opportunities, through in-house development and strategic partnerships, including multi-functional immuno-oncology modulators and Humabody® Drug Conjugates (HDCs), the next generation of ADCs. Humabody®-based formats can also be applied across a range of non-cancer indications.
Crescendo Biologics is located in Cambridge, UK, and is backed by blue-chip investors including Sofinnova Partners, IP Group, Takeda and Astellas.
Zai Lab (NASDAQ:ZLAB) is a Shanghai-based innovative biopharmaceutical company focused on bringing transformative medicines for cancer, autoimmune and infectious diseases to patients in China and around the world. Zai Lab’s experienced team has secured partnerships with leading global biopharma companies, generating a broad pipeline of innovative drug candidates targeting the fast-growing segments of China’s pharmaceutical market and global unmet medical needs. Zai Lab’s vision is to become a fully integrated biopharmaceutical company, discovering, developing, manufacturing and commercializing its partners’ and its own products in order to impact human health worldwide.
Chinese fund manager CDH Investments has raised a sum of $1 billion for its China-focused fifth mezzanine fund, according to a report by Private Debt Investor. The first close of the fund came late last year at $484 million, with backers including insurance companies, banks, trust companies and other institutional investors.
Once officially closed, the fund is expected to more than double the size of the previous mezzanine fund, which secured a total fund of $529 million in 2016 and focused on mergers and acquisitions. It will provide capital to growth-stage companies in education, healthcare, energy, and the consumer sectors.
CDH Investment Managing Director Ning Hu had told local media that CDH’s four mezzanine funds are all fully invested, and its first fund is fully exited, securing returns higher than the 11 per cent average for the market.
Launched in 2011, CDH Mezzanine and Credit provides financing for mergers & acquisitions, high growth private businesses, fixed assets investments and non-performing assets. It offers investors a variety of creative structures, including convertible bonds, preferred debt, subordinated debt, buyback of shares and allocation of equity interests.
On its website, the company says its mezzanine fund manages more than $1.3 billion in assets across four RMB funds. Since its inception, CDH Mezzanine and Credit has reportedly invested in 58 projects and completed exits for 60 per cent of its investments, according to its website.
CDH Investments is an alternative investment fund managers focused on China with over $17 billion of assets under management, as of December 31, 2017.
Established in 2002, CDH has grown beyond its private equity root and become a diversified alternative asset management platform covering real assets, venture and growth capital, mezzanine & credit, public equities and wealth management.
In one of its latest moves, CDH is said to have made a $1.41 billion offer for Australia’s liver-cancer treatment specialist Sirtex Medical. The acquisition is conditional upon approval of Australia’s Foreign Investment Review Board.
Read more at: https://www.dealstreetasia.com/stories/cdh-investments-mezzanine-fund-97747/
WALTHAM, Mass. and SHANGHAI, China, April 25, 2018 (GLOBE NEWSWIRE) — Entasis Therapeutics Holdings Inc., a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, and Zai Lab Limited (NASDAQ:ZLAB), a Shanghai-based innovative biopharmaceutical company, today announced an exclusive license agreement for ETX2514 in the Asia-Pacific region and a global strategic development collaboration. Entasis’ ETX2514 is a novel broad-spectrum intravenous inhibitor of β-lactamases, which are a major cause of antibiotic resistance. Entasis is developing ETX2514SUL, a fixed-dose combination of ETX2514 and sulbactam, for the treatment of a variety of serious multidrug-resistant infections caused by Acinetobacter baumannii, representing a healthcare challenge of global importance with over 200,000 occurrences estimated in China each year. ETX2514SUL is currently in Phase 2 development with plans to move into global Phase 3 clinical trials in the first quarter of 2019. Zai Lab will manage the portion of the Phase 3 trial conducted in China.
“Entasis remains committed to building a pipeline of life-saving treatments for patients affected by drug-resistant bacterial infections around the world. We are thrilled to partner with Zai Lab on the further development and potential commercialization of ETX2514SUL in the Asia-Pacific region, most notably in Greater China, where the rate of A. baumannii infections rank among the highest in the world,” said Manos Perros, Chief Executive Officer of Entasis. “With their experienced leadership team, focus on innovation and established expertise and network within the infectious diseases arena, Zai Lab is the ideal partner to help bring ETX2514SUL to the numerous patients in the region who need a new effective treatment option. The collaboration will offset costs and enable enrollment of patients from China into our global Phase 3 clinical trial, further supporting our plans to rapidly progress ETX2514SUL to market.”
“Infectious diseases are a key focus area for Zai Lab due to the serious problem of multidrug-resistant infections both in China and globally. We are excited to collaborate with Entasis, a company that has extensive expertise and know-how in developing anti-infective products that address multidrug-resistant infections, and we look forward to working together to accelerate the global development of this potential life-saving therapy. We expect ETX2514SUL will be a positive addition to Zai Lab ’s anti-infective portfolio, and we remain committed to developing a drug to combat multidrug-resistance, which currently poses a serious global threat to our society,” stated Samantha Du, Ph.D., Chairman and Chief Executive Officer of Zai Lab. “This collaboration reinforces the strength of the Zai Lab team both in China and globally, and we believe will help us further progress on our mission to establish Zai Lab as an innovative, fully integrated, global pharmaceutical company.”
Under the terms of the agreement, Entasis has granted Zai Lab an exclusive license to develop and commercialize ETX2514SUL in specified countries in the Asia-Pacific region, including Japan. Entasis and Zai Lab will cooperate in conducting a pivotal Phase 3 trial in China, with Zai Lab taking the lead by conducting the screening, enrollment and treatment of patients, and coordinating development, registration and commercialization of ETX2514SUL in the territory. In addition, Entasis and Zai Lab have an option to collaborate on the development and commercialization of ETX2514 in combination with other active ingredients. A joint steering committee will be formed between the companies to oversee development, regulatory and commercialization activities in the Asia-Pacific territory. In addition to financial support for the portion of the Phase 3 trial conducted in China, Entasis will receive a $5 million upfront payment and is eligible to receive up to an aggregate of $7.6 million in near-term development milestones and up to an aggregate of $91.0 million in additional development, regulatory and sales milestone payments related to ETX2514SUL and other combinations, plus royalties.
Tocagen has granted ApolloBio exclusive rights to its Phase III two-part cancer immunotherapy candidate Toca 511 (vocimagene amiretrorepvec) and Toca FC in the greater China region, in a deal that could generate up to $127 million-plus for Tocagen.
Under the companies’ license agreement, ApolloBio has agreed to develop and commercialize biologic Toca 511 and small-molecule Toca FC in China as well as Hong Kong, Macao, and Taiwan.
Toca 511 is a retroviral replicating vector designed to selectively infect cancer cells and deliver a gene for the enzyme cytosine deaminase (CD). The infected cancer cells then carry the CD gene and produce CD.
Toca FC is an oral extended-release formulation of the prodrug 5-fluorocytosine (5-FC), which is converted into an anticancer drug, 5-fluorouracil (5-FU), when it encounters CD. 5-FU is designed to kill cancer cells and immune-suppressive myeloid cells in the tumor microenvironment, which according to Tocagen results in anticancer immune activation and subsequent tumor killing.
Toca 511 and Toca FC are under study in the global Phase III Toca 5 trial (NCT02414165) in patients with recurrent high-grade glioma. The study is estimated to enroll 380 participants and has an estimated primary completion date of December 2019.
The two-part cancer immunotherapy has received the FDA’s Breakthrough Therapy designation and the European Medicines Agency’s PRIority MEdicines (PRIME) designation.
ApolloBio has agreed to pay Tocagen $16 million upfront, and up to $111 million in payments tied to achieving development and commercial milestones—including a $4 million payment for “near-term” milestones that include completion of the clinical trial. Tocagen is also eligible to receive low double-digit tiered royalty payments based on net sales.
“ApolloBio brings valuable regional expertise in product development, regulation, and healthcare access, positioning our lead product to advance toward patients in the greater China region as quickly and efficiently as possible,” Tocagen CEO Marty Duvall said in a statement. “As an innovative biopharmaceutical company in China, ApolloBio is well positioned to leverage China’s recent regulatory changes supporting the development of new medicines.”
China’s FDA last year began carrying out reforms designed to shorten reviews and approval timeframes for new drugs and devices. The reforms include acceptance of data from clinical trials conducted outside China, quicker reviews of drugs and devices intended to address life-threatening diseases or critical unmet medical needs, and conditional approvals for new rare disease drugs that already have approvals elsewhere in the world.
Last month, China’s State Council proposed creation of a new State Drug Administration that would oversee reviews and approvals of drugs and medical technologies, supplanting the China FDA—in the latest move to align China’s drug regulation with global standards, also reflected in China joining the International Council for Harmonization.
The companies said the number of projected new diagnoses of high-grade glioma this year were about 47,000 in greater China and 180,000 worldwide. Standard treatment includes surgery, radiation therapy, and chemotherapy.
“Toca 511 and Toca FC is a highly promising, best-in-class cancer-selective immunotherapy, and we look forward to working with Tocagen to advance this innovative late-stage product toward commercialization,” added ApolloBio CEO Weiping Yang, Ph.D.
ApolloBio’s license is subject to satisfaction of customary conditions, and is expected to become effective in the second quarter, the companies said.
SHANGHAI, April 16, 2018 /PRNewswire/ — Qiming Venture Partners (“Qiming”, www.qimingvc.com), a leading venture capital firm in China, today announced the successful closing of three new funds totaling $1.39 billion. The new funds include Qiming Venture USD Fund VI with $935 million in commitments and Qiming Venture RMB Fund V with ￥2.1 billion in commitments, focused on the investment in outstanding Chinese entrepreneurs in the Internet and Consumer (“Intersumer”), Healthcare, Information Technology and Cleantech sectors. In addition, Qiming closed Qiming U.S. Healthcare Fund I with $120 million in commitments, focused on early-stage healthcare opportunities in US. With these new funds, Qiming now manages over $4 billion across 12 funds.
Qiming’s portfolio includes over 250 investments distributed among its targeted sectors. Qiming Venture Partners invests in early-stage and expansion-stage deals, with over 50% of its investments in early-stage companies. At least 20 private companies in the Qiming portfolio are now valued at $1 billion or more, and 17 of which have grown up to be the real unicorns in the industry, including Xiaomi, UBTech, We Doctor Group, Face++, APUS, Mobike, Tujia.com, Tuhu.cn, TutorGroup (VIPABC), Zhihu, Luojisiwei, Gan & Lee, Meituan-Dianping, Wacai.com, Musical.ly, Meili Inc. and Sinocelltech.
Outstanding Qiming Core Team
There are currently over 30 investment professionals within Qiming China and Qiming US, and all the senior team members have strong investment and operation experience coveted by today’s entrepreneurs.
Qiming China takes great pride in its investment team. Managing Partners Gary Rieschel, Duane Kuang, JP Gan, Nisa Leung, and William Hu are all recognized leaders in their respective areas and within the venture capital community. They are proud to be joined by Partners Yong Zhang, Grace Lee, Janet Yu, Helen Wong, Jing Wu, Kuantai Yeh and Steven Hu as the leadership team for Qiming. In the meantime, Principals Peter Yin, Stella Zhou, Alex Zhou and Bonnie Wang have gradually established themselves among the new generation of young and outstanding investors in the venture community.
For the newly established Qiming US health care fund, under the leadership of founding Managing Partner Gary Rieschel, Mark McDadeand Chris Shen joined as Managing Partners and Jennifer Hu as Partner.
9 IPOs in the past 18 months
Over the past 18 months, Qiming team have made dazzling achievements, with 9 portfolio companies successfully completed IPOs in China, HK and US market.
Hexing, a multi-national company offering a variety of electrical equipment and relevant solution to global power utilities, was successfully listed on the main board of Shanghai Stock Exchange in November 2016
Meitu Inc., a leading photo editing and self-photographing application developer and smart phone provider in China, was successfully listed on the Hongkong Exchange in December 2016
CSD, a comprehensive water service provider, focused on water treatment, sewage and sludge treatment, was listed on the main board of Shanghai Stock Exchange in March 2017
Tellgen, a high-tech enterprise specializing in the development, production and promotion of high-end extracorporeal diagnostic reagents, was listed on the Shenzhen ChiNext board in April 2017
AmoyDx (SZ 300685), a leading developer for cancer companion diagnostics, was listed on the Shenzhen ChiNext board in August 2017
Berry Genomics, an industry leader of gene sequencing technology to realize clinical transformation, completed its back-door listing on the main board of the Shenzhen Stock Exchange in September 2017 and announcement of Change of Name
Zai Lab, a leading biotech company in China developing innovative medicines, focusing on large unmet medical needs in China, hit Nasdaq with IPO in September 2017
Bilibili, a China’s top online anime and video streaming site, successfully landed on Nasdaq in March 2018, marking a milestone in ACGN culture
ARMO Biosciences, a clinical trial stage immune-oncology company successfully completed an IPO in January, 2018.
“We are pleased to announce a series of new funds for Qiming Venture Partners. We have closed our sixth dollar-based vehicle for China (Qiming VI) at the $935M cap, our fifth RMB-denominated vehicle (Qiming RMB V) at 2.1billion RMB, and our first fund focused outside of China, Qiming U.S. Healthcare I, also closed at its $120M cap. The performance of Qiming has validated our team and sector-focused strategy, with every Partner in the firm generating positive returns to LPs, as well as each sector having multiple IPOs in the last two years. All our LPs from prior China funds returned for the latest funds, and we had significant overlap between our China Fund and U.S. Fund investors,” said Gary Rieschel, Founding Managing Partner of both Qiming China and Qiming US. “It has been incredibly rewarding to be part of the development of Qiming over the past twelve years. We have now raised over $4B dollars or dollar-equivalent, and are consistently ranked in the very top echelon of China-based venture investors.”
Jim Millar, Managing Director at Princeton University Investment Company said, “Qiming has developed a strong reputation as a leading venture capital firm and is notable for its culture of partnership within the firm, with entrepreneurs, and with LPs. Princeton is proud to have partnered with Qiming since inception as its anchor investor.”
Most of the LPs in Qiming Venture USD Fund VI and Qiming Venture RMB Fund V are returning LPs from prior Qiming funds. The U.S. fund LPs include Princeton University, MIT, Duke University, Commonfund, Hall Capital Partners, Mayo Clinic, The Dietrich Foundation and NGS Super among others. The RMB fund LPs include Oriza FOFs, CDB Capital FOF, CICC, Xiamen C&D Corporation, Suzhou Fund, LUPU Investment and Hang Tang Wealth.
About Qiming Venture Partners
Founded in 2006, Qiming is a leading China venture capital firm with offices in Shanghai, Beijing, Suzhou, Shenzhen and Hong Kong. In 2017, Qiming raised its first US fund and set up Qiming’s US offices in Seattle, Boston, and Palo Alto. Currently, Qiming manages seven US Dollar funds and five RMB funds with US$4 billion assets under management.
Qiming strives to be the investor of choice for top entrepreneurs in China. Since our debut, we have backed over 250 young, fast-growing and innovative companies across China in the internet and consumer (“Intersumer”), healthcare, information technology and clean technology sectors. Over 50 of them are already listed on NYSE, NASDAQ, HKEx, Gretai Securities Market, Shanghai Stock Exchange, and Shenzhen Stock Exchange or achieved exit through M&A. There are also nearly 20 portfolio companies that have been recognized as unicorns in the industry. And many of our portfolio companies are today’s most influential brands in their respective sectors, including Xiaomi, Meituan-Dianping, TutorGroup (VIPABC), Meili Inc., Meitu, Bilibili, Tigermed, Gan & Lee, Zai Lab, Hexing, CSD, Tellgen, AmoyDx, Berry Genomics, HyperStrong, We Doctor Group, Face++, UBTech, Mobike and JingChi. Qiming consistently ranks among the top venture firms in terms of returns to its investors.
Qiming drives innovation and growth of business enterprises and promotes overall industry advancement and social development. With access to our partners’ experience and global network as well as our excellent industry background, we spare no efforts in helping our entrepreneurs and their companies succeed!