China Renaissance Capital Medical and Life Sciences Weekly Report[Vol.221]

The "China Renaissance Capital Medical and Life Sciences Industry Weekly Report" is released regularly, focusing on interpreting the week's data from the perspective of capital and providing the latest industry observations.

Healthcare & Life Sciences has been a focus and depth of attention for Manyring Capital for many years, and has served as financial advisors for nearly 150 financing and M&A projects.

Innovation in the medical and life science and technology industry continues to emerge, has developed into one of the most active industries, China Renaissance Capital has always supported and accompanied the growth of entrepreneurial enterprises in this field, and is committed to bringing a rational and professional voice to the industry.

Author | China Renaissance Capital Medical & Life Science Team

Pay attention to China Renaissance WeChat public account (ID: iChinaRenaissance), click "Xing Viewpoint" - "Industry Observation" - "Life Science and Technology" in the background to get more information about the medical and life science and technology industry.

On May 5, 2022, Gloria Spectrum completed a financing of rmb 100 million, led by ZHONGJIN Jiatai Fund, with Rehabilitation Capital, Qishen Venture Capital, West Lake Science and Technology Venture Capital, and Zhongjin Pucheng co-investing, with Huaxing Capital acting as the exclusive financial advisor.

Company Reviews:

Gloria Spectrum is a developer of clinical mass spectrometry technology dedicated to promoting the clinicalization and standardization of mass spectrometry and multi-omics. The company has leading proteomics and single-cell genomics service capabilities, the core product "Clinical Mass Spectrometry Detection System CalQuant-S" was approved by NMPA in March 2022, and has a variety of approved reagent products, which has realized the comprehensive coverage of the clinical mass spectrometry standardization overall solution of its own products.

On May 7, 2022, Xinlitai Bio completed a series A financing of hundreds of millions of yuan, led by Cinda Kunpeng.

Company Reviews:

Xinlitai Bio is a cardiovascular and cerebrovascular device developer of Xinlitai Pharmaceutical, the business covers neurointervention, cardiovascular intervention, peripheral blood vessels, structural heart disease and other fields, the company's core product Maurora vertebral artery stent was approved by THE NMPA in 2020, is the world's first rapamycin carrier stent for vertebral artery stenosis. The company's main research products are cardiovascular interventional device rapamycin coronary drug balloons, which have entered the registered clinical stage.

On May 7, 2022, Spectral Medical completed a rmb A financing of RMB 100 million, led by Legend Capital, and followed by Brilliant Capital, Wilder Capital and Yangyun Capital.

Company Reviews:

Spectrum Medical is a medical technology company focusing on building a high-end active cardiac and vascular interventional technology platform. The company's core product under research is the intravascular shockwave balloon catheter system Sonico, which has entered the clinical trial stage and completed the first case of enrollment, mainly for the treatment of arterial vascular calcification.

On May 5, 2022, Xinsu Technology completed tens of millions of yuan angel + round of financing, led by Qiming Venture Capital, followed by Fengrui Capital and Xinhang Capital.

Company Reviews:

Xinsu Technology is the first molecular chip DNA synthesis technology developer in China, which is committed to the development of molecular chip-driven biotechnology semiconductorization. At present, Xinsu Technology has completed the prototype of high-throughput DNA synthesizer and established a fully automatic sequence analysis platform, which will gradually expand to the fields of high-throughput RNA and protein synthesis and detection in the future.

On May 5, 2022, Enumera completed a $12.5 million Series A funding round, led by Arboretum Ventures.

Company Reviews:

Enumera is a clinical biotech developer dedicated to the development and commercialization of rapid, low-cost liquid biopsy testing technologies. Enumera was spun off from the liquid biopsy business of parent company Progenity, a developer of molecular diagnostic products for women's health.

Hello Heart completed a $70 million Series D funding round, led by Stripes.

Company Reviews:

Hello Heart is a heart-health-focused digital treatment company with a health management APP whose core products are health management apps that track patients' blood pressure, while sending medication reminders and providing dietary advice based on behavioral science and AI to improve users' lifestyle habits to reduce the risk of diseases such as heart disease and stroke.

On May 3, 2022, LetsGetChecked acquired BioIQ for an undisclosed amount.

Company Reviews:

LetsGetChecked is a home-based testing product developer covering a wide range of health areas such as diabetes, cardiovascular disease, and oncology. BioIQ is an analytics-oriented developer of population health and diagnostic software. The acquisition will expand LetsGetChecked's customer base and also provide BioIQ's customers with new virtual care options.

On May 6, 2022, Boerun was listed on the New York Stock Exchange and the Toronto Stock Exchange, raising $630 million in initial capital.

Company Reviews:

Bo Lun is an eye care company, the main business covers vision care, eye medicine, surgery three areas. Bolun has the industry's most extensive contact lens portfolio, including multifocal, polytactic and multifocal complex flexible contact lenses, beauty pupils, etc., occupying the first position in sales in China, Thailand, India and other markets.

○ This week's industry news

Zhifei Bio's COVID-19 vaccine is 75.7% effective

On May 4, 2022, the New England Medical Journal published phase III clinical data on the ZF2001 RBD dimer covid-19 vaccine. The data showed that the overall protection rate of ZF2011 was 75.7%, the protection rate against severe illness was 87.6%, the protection rate against death was 86.5%, and the effectiveness rate against Delta mutant strains was 76.1%. ZF2001 also has a good safety profile, comparable to the incidence of side effects in the placebo group.

Source: Medical Notes

Ningbo took the lead in introducing the medical insurance price limit policy for implants

On April 29, 2022, the Ningbo Municipal Medical Security Bureau issued the "Five Questions and Five Answers" of the Dental Implant Medical Insurance Limit Payment Policy, which fully launched the Dental Implant Medical Insurance Price Limit Payment Policy. The policy stipulates: the whole process of dental implants is limited to 3,000 yuan / piece for domestic brands and 3,500 yuan / piece for imported brands, of which the price of consumables is 1,000 yuan / piece for domestic production and 1,500 yuan / piece for imports; the dental implants within the agreed brand range of the hundred medical institutions currently signed, whether they use the medical insurance calendar year account payment or cash payment, must ensure the same price in the same city; implant teeth that are not in the brand directory, the medical insurance calendar account will not be paid.

Source: House of Instruments

1. The First Third Communist/AstraZeneca Blockbuster ADC was approved by the FDA

2. BeiGene "Belito" was approved in China for the second item

3. Finch Therapeutics oral microbiome therapy Phase 3 clinical trial was approved for restart

4. Autolus differentiated CAR-T therapy was recognized as an advanced therapy for regenerative medicine

5. Limaca Medical's endoscopic ultrasound biopsy products have been certified by the FDA as breakthrough equipment

6. The first digital therapy for people with three high and chronic diseases in China was approved

7. A number of medical device products were approved for listing

The First Third Communist/AstraZeneca Blockbuster ADC was approved by the FDA

On May 6, 2022, trastuzumab deruxtecan (T-DXd), jointly developed by First Third Republic and AstraZeneca, was approved by the FDA for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received at least one anti-HER2 treatment regimen during the metastatic phase, or who have had a recurrence of the disease during and within six months of receiving neoadjuvant or adjuvant therapy. T-DXd is a HER2-targeted antibody-conjugated drug that has been shown in Phase III trials to significantly reduce the risk of disease progression or death in patients with HER2-positive unresectable and/or metastatic breast cancer who have previously been treated with trastuzumab and paclitaxel.

Source: Medicine Cube

BeiGene 'Belitol' received a second approval in China

On May 4, 2022, BeiGene's "Belitomol (Berintoumab for Injection)" was approved by NMPA for the treatment of relapsed or refractory CD19-positive precursor B-cell acute lymphoblastic leukemia in children. Bellito is a BiTE (bispecific T cell articulation molecule) immuno-oncology therapy that has previously been conditionally approved in China for the treatment of adult patients with this indication.

Source: PR Newswire

Finch Therapeutics oral microbiome therapy Phase 3 clinical trials were approved for restart

On May 2, 2022, Finch Therapeutics announced that the FDA has approved the continuation of its clinical trial of oral microbiome therapy CP101 for the prevention of recurrent Clostridium difficile infection. Previously, the FDA did not approve the trial because the microbiome contained in CP101 was derived from donor feces and was at risk of carrying the virus during the new crown. CP101 has been granted FAST TRACK qualification and breakthrough therapy accreditation by the FDA.

Source: WuXi AppTec

Autolus' differentiated CAR-T therapy was recognized as an advanced therapy for regenerative medicine

On May 2, 2022, Autolus Therapeutics' therapies Obe-cel was awarded the FDA's Advanced Therapy for Regenerative Medicine. Obe-cel is a CAR-T therapy that targets CD19 and is undergoing Phase 2 clinical trials for the treatment of relapsed/refractory adult B-cell acute lymphoblastic leukemia. Obe-cel's chimeric antigen receptors have a faster dissociation rate after binding to the target, which can reduce the over-activation of T cells, enhance the efficacy and durability of CAR-T therapy.

Source: WuXi AppTec

Limaca Medical's endoscopic ultrasound biopsy products receive breakthrough equipment certification from the FDA

On May 6, 2022, Limaca Medical's "Precision-GI Endoscopic Ultrasound Biopsy Product" was certified as a breakthrough device by the FDA. Precision-GI is mainly used to obtain tumor tissue in or adjacent to the gastrointestinal tract, and can use ultrasound visualization endoscopy to enter the target gastrointestinal tract, which is suitable for gastrointestinal tumor locations including submucosal lesions, mediastinal masses, lymph nodes, intraperitoneal masses, etc.

Source: CCI Cardiovascular Doctor Innovation Club

The first digital therapy for people with three high and chronic diseases in China was approved

On May 7, 2022, MiaoHealth-DTx1, a digital therapy product for people with three high chronic diseases under Miao Health, was approved for marketing by NMPA. The product is a physiological parameter management and analysis software, using active health intervention technology, can be used in diabetes, hypertension, medical obesity, sleep psychology and other fields of treatment and chronic disease management services.

Source: Arterial Network

A number of medical device products were approved for listing

Digital Kun Technology's "Ct Image Assisted Diagnostic Test Software for Lung Nodules" was approved by NMPA for listing

Source: House of Instruments

E-Media Medical's "Speedpass Thrombotic Catheter" was approved by NMPA for marketing

Source: Neurointerpretation Online

iSono Health's "ATUSA Portable Automated 3D Breast Ultrasound Scanner" was approved for marketing by the FDA

Source: House of Instruments

Orthofix Medical's "AccelStim System, a mechanism that stimulates bone healing," was approved for marketing by the FDA

Source: Arterial Network

Johnson & Johnson 'MONARCH Soft Robot' was approved by the FDA for new indications for urological stone retrieval

Source: MedTF

Saikai Bio's "Triple Detection (Novel Coronavirus, Influenza A Virus and Influenza B Virus Antigen) Kit" was CE certified

Source: In vitro diagnostic network

1. Bayer's "Rivarsaban dry suspension" was approved in China

2. Covering all types of patients with heart failure, dapagliflozin reached the stage 3 clinical endpoint

3. The first patient in the global phase III clinical trial of Mengke Pharmaceutical began to administer the drug

4. Mona Lisa prostate puncture robot completes all clinical enrollment

5. Medtronic DCB product IDE research results for 3 years are announced

Bayer's "Rivarsaban dry suspension" was approved in China

On May 7, 2022, Bayer's "Rivaroxaban Dry Suspension" was approved by the NMPA for the treatment of venous thromboembolism and recurrence prevention after initiation of standard anticoagulation therapy in term neonates, infants, children and adolescents under 18 years of age. Developed jointly by Bayer and Janssen, a Johnson & Johnson subsidiary, Rivaroxaban is a highly selective, direct inhibitor of factor Xa orally.

Source: Medicine Guanlan

Covering all types of patients with heart failure, dapagliflozin reached a stage 3 clinical endpoint

On 6 May 2022, AstraZeneca 'SGLT2 inhibitor dapagliflozin' achieved the primary endpoint in a Phase 3 clinical trial in patients with mildly reduced ejection fraction or conserved ejection fraction, demonstrating that it could provide a statistically significant and clinically significant improvement in the risk of cardiovascular death or worsening heart failure. Combined with previous clinical trials in patients with reduced ejection fraction, the results showed that depagliflozin was able to produce efficacy in patients with heart failure regardless of ejection fraction.

Source: WuXi AppTec

The first patient in the global phase III clinical trial of Mengke Pharmaceutical began to be administered

On May 1, 2022, the first clinical trial of MRX-4 and contezolid tablets for injection of the new drug of anti-drug resistant bacteria in The Global Phase III clinical trial for the treatment of diabetic foot infection began registration at the Harbor-UCLA Medical Center in Los Angeles. This clinical trial will also serve as a study of the indications for further expansion of contezolid tablets. Previously, both contezolid tablets and MRX-4 for injection have been CERTIFIED by the FDA for QIDP, with fast-track eligibility and additional aftermarket exclusive rights protection.

Source: PR Newswire

The Mona Lisa prostate puncture robot completes all clinical enrollment

On April 29, 2022, the Mona Lisa Prostate Puncture Robot Positioning System developed by Minimally Invasive Robotics and Minimally Invasive Median Robot, a joint venture between Microport Robotics and Biobot Surgical, completed all registered clinical enrollment trials, becoming the first prostate puncture robot in China to complete a multi-center clinical trial. Mona Lisa has the advantage of increasing prostate cancer detection rates over manual punctures and greatly avoids damaging the patient's rectum and urethra.

Source: House of Instruments

Medtronic DCB product IDE study 3-year results were announced

On April 27, 2022, Medtronic's drug-coated balloon product IN.PACT AV Access IDE 3-year study was published, demonstrating the safety and efficacy of IN.PACT AV DCB in the treatment of primary stenosis or restenosis lesions of autologous arteriovenous fistula (AVF) of the upper extremities, providing strong support for the use of DCB as the standard of care for AVF maintenance in patients with end-stage renal disease.

Source: Clinic Clinic New Horizons

1. Lixin Pharmaceutical and Turning Point reached a $1 billion cooperation

2. Amphista Therapeutics has entered into a strategic partnership with Merck Healthcare

3. Illumina and Deerfield Management reach a partnership

4. Gilead collaborates to develop natural killer cell therapies

5. DNAGO announces merger with Oncologix Tech

Lesnes Pharma and Turning Point reach a $1 billion partnership

On May 5, 2022, Lexion Pharmaceuticals and Turning Point entered into a cooperation agreement to introduce lecional Pharma Claudin 18.2 ADC LM-302 global interests in addition to Greater China and South Korea. The total amount of the agreement exceeds $1 billion and includes an advance payment of $25 million, a development and regulatory milestone payment of $195 million, and a sales milestone payment and sales share. In the future, the two sides can also jointly develop three new ADC drugs to expand the scope of cooperation.

Source: Medical Notes

Amphista Therapeutics has entered into a strategic partnership with Merck Healthcare

On May 4, 2022, Amphista Therapeutics announced a strategic partnership with Merck Healthcare, a subsidiary of Merck. The two companies will leverage Amphista's Eclipsys TPD platform to develop novel protein degradation therapies in the fields of oncology and immunology. The collaboration currently consists of three projects involving up to €39 million in advances and R&D funds. Amphista may receive payments of up to €893.5 million, as well as royalties.

Source: Pharmaceutical Fusion Circle

Illumina and Deerfield Management have partnered

On May 6, 2022, Illumina and Deerfield Management announced a five-year partnership. Illumina, a DNA sequencer developer, will use Illumina's genetics-driven drug discovery platform to discover new therapeutic targets and develop innovative therapies for diseases with unfinished medical needs. The goal of this collaboration is to use genomics tools and genetic validation to improve the success rate and speed to market of projects while reducing costs.

Source: WuXi AppTec

Gilead collaborates to develop natural killer cell therapies

On May 3, 2022, Gilead Sciences and Dragonfly Therapeutics entered into an R&D collaboration to advance a range of Dragonfly immunotherapies based on innovative natural killer cell artigmater proteins for oncology and inflammatory indications. Gilead will pay an upfront payment of $300 million and subsequent milestone payments to acquire a development interest in Dragonfly's 5T4-targeted DF7001, an active immunotherapy, and an option to acquire an R&D interest in other candidate therapies developed on the company's TriNKET platform.

Source: WuXi AppTec

DNAGO and Oncologix Tech announced a merger

On May 4, 2022, Oncologix Tech and DNAGO entered into a merger agreement. The combined company will continue to conduct clinical genetic testing of DNAGO and work to democratize the price. DNAGO's AI genetic detection system already covers all 20,000 genes, including more than 7,000 rare genetic diseases. Oncologix Tech is a provider of healthcare care services that also sells home medical devices in the field of sleep and respiratory therapy.

Source: Gene Valley

1. Illumina was found to have completely infringed two BGI patents

2. Juzi Biotech submitted an application for listing on the Hong Kong Stock Exchange

3. Innova Healthcare submits an application for listing on the Hong Kong Stock Exchange

4. Cochlear intends to acquire Oticon Medical for $170 million

5. The first domestic laser proton accelerator landed

Illumina was found to have completely infringed two BGI patents

On May 6, 2022, a U.S. federal jury in Delaware found that Illumina had completely infringed two DNA sequencing patents of BGI subsidiary Compute Genomics Inc. (CGI) and was liable for 334 million yuan in damages. The jury ruled that Illumina was intentionally infringing, while declaring three patents that Illumina found CGI to infringe invalid. Affected by this incident, Illumina shares fell 15.41%.

Source: Gene Technology Network

Juzi Biotech submitted an application for listing on the Hong Kong Stock Exchange

On May 7, 2022, Juzi Biotech submitted a listing application to the main board of the Hong Kong Stock Exchange, with Goldman Sachs and CICC as its joint sponsors, and the IPO plans to raise 5 to 1 billion US dollars. Juzi Bio is a pioneer and leader in China's professional skin care products industry based on bioactive ingredients, and its core products are professional skin care products with recombinant collagen as the key bioactive ingredient.

Source: Medactive

INNOVA Healthcare submits an application for listing on the Hong Kong Stock Exchange

On 29 April 2022, Innova Healthcare submitted a prospectus to the Hong Kong Stock Exchange for an IPO on the Main Board of Hong Kong. Innova Healthcare is a medical group focused on providing total solutions in the minimally invasive field, focusing on the research and development of non-vascular interventional surgical instruments in urology, gastroenterology and other fields. A total of 31 products have been approved for listing in many countries around the world, and have penetrated more than 1,500 hospitals in China.

Source: House of Instruments

Cochlear intends to acquire Oticon Medical for $170 million

On May 4, 2022, global cochlear giant Cochlear announced its intention to acquire Danish hearing implant company Oticon Medical for A$170 million. Oticon Medical is still in a loss-making position, and its parent company Demant said that due to excessive investment in research and development, the group will withdraw from the hearing implant market. Cochlear currently has a 55% share of the global cochlear implant market and Oticon Medical ranks fourth in market share, and this acquisition will further strengthen Cochlear's monopoly position.

Source: House of Instruments

The first domestic laser proton accelerator landed

On April 22, 2022, Peking University pre-spent 9.85 million yuan to purchase a set of horizontal beam wire magnet system for the research and application of the watt laser proton accelerator device. The magnet system mainly provides focusing, energy selection, guidance, orbital correction, distribution uniformization, scanning and other functions for the laser-accelerated proton beam in the horizontal beam stream transmission process to ensure the beam transmission efficiency and beam quality. The project belongs to the national key research and development program "major scientific instruments and equipment development" special project, aiming at the development and industrialization of laser proton radiotherapy products.

Source: House of Instruments

○ Recent developments in the medical and life science and technology capital markets:

Overview of recent transactions

(May 1 - May 7, 2022)

Note: Overseas secondary market refers to Hong Kong stocks and US stocks

*Source: Internal collation by China Renaissance Capital

List of listed companies' market capitalization and valuation multiples

Market Cap Date: May 6, 2022

Market capitalization unit: millions of dollars

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*Source: Capital IQ, Prospectus, Research Report, Company Annual Report