On August 23, 2022 Mabwell (stock code: 688062.SH), an innovative biopharmaceutical company with the layout of the whole industry chain, reported that the IND application for the self-developed 6MW3511 injection has been formally approved by the Center for Drug Evaluation (CDE) of China National Medical Products Administration for clinical trial in advanced solid tumor (Press release, Mabwell Biotech, AUG 23, 2022, View Source [SID1234618983]).

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6MW3511 is a bifunctional group drug protein independently constructed by Mabwell using humanized anti-PD-L1 nanobodies to link to TGF-β RII mutants. The mutant design facilitates the maintenance of whole-molecule stability and reduces degradation of the natural TGF-β group during the manufacture process and in vivo. By blocking PD-1/PD-L1 and TGF-β/TGF-β-R dual pathways simultaneously, and with the excellent local tumor penetrability resulting from the concise structure, 6MW3511 is expected to further address the difficult problem of immunosuppression in the tumor microenvironment. The results of preclinical studies showed that 6MW3511 injection had good in vivo anti-tumor efficacy and good tolerability in animals.

On August 23, 2022 Labcorp (NYSE: LH), a leading global life sciences company, reported that it has closed its acquisition of RWJBarnabas Health’s outreach laboratory business and select related assets. RWJBarnabas Health is New Jersey’s largest academic health system (Press release, LabCorp, AUG 23, 2022, View Source [SID1234618593]).

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"The communities, physicians and health systems we serve are central to everything we do at Labcorp," said Bill Haas, senior vice president of Labcorp Diagnostic’s Northeast Division. "Our expanded relationship with RWJBH will build on the solid foundation RWJBarnabas Health has developed, and will offer patients and providers enhanced access to high-quality laboratory services, seamless data integration and connectivity and exceptional value to help improve patient care and outcomes."

Through this collaboration, RWJBarnabas Health’s physicians and patients will be able to access an expanded test menu, as well as Labcorp’s extensive network of patient service centers, which includes Labcorp at Walgreens. In addition, for patients who have been served by a RWJBarnabas Health laboratory, Labcorp will offer expanded health plan coverage, enhanced service to rural markets and the potential for reduced out-of-pocket lab costs for patients. Same day and STAT testing will also be available in local communities.

"At RWJBarnabas Health, we take pride in creating and sustaining healthy communities by providing high-quality health care throughout New Jersey," said John Doll, senior executive vice president and chief operations officer of RWJBarnabas Health. "By working alongside Labcorp, we will provide comprehensive testing services and enhance the laboratory service offerings. We are always evaluating how best to serve our patients, clinicians and physicians. This strategic business decision will provide a high-performing, streamlined outreach network to support our community."

Additional terms of the transaction were not disclosed.

On August 23, 2022 I-Mab ("I-Mab" or the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported that it plans to implement share repurchases pursuant to the share repurchase program previously authorized by its Board of Directors (Press release, I-Mab Biopharma, AUG 23, 2022, View Source [SID1234618591]). On the same day, the Company was also informed by Dr. Jingwu Zang, Chairman and Acting Chief Executive Officer of the Company, and other members of senior management of their intention to use personal funds to purchase the Company’s American Depositary Shares (the "ADSs") on the open market. Under the share purchase plans, the Company and the senior management may purchase up to US$40 million of ADSs in aggregate.

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The timing and dollar amount of share repurchase and share purchase transactions will be subject to the applicable U.S. Securities and Exchange Commission rule requirements. The Company’s Board of Directors will review the implementation of share repurchases periodically, and may authorize adjustment of its terms and size.

On August 23, 2022 Medtronic plc (NYSE:MDT) reported financial results for its first quarter of fiscal year 2023, which ended July 29, 2022 (Press release, Medtronic, AUG 23, 2022, View Source [SID1234618587]).

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Key Highlights

"We’re executing in a challenging environment with several pipeline catalysts approaching." Chairman & CEO Geoff Martha

FY23 Q1 Earnings
FY23 Q1 Earnings
GAAP diluted EPS of $0.70 increased 25%; non-GAAP diluted EPS of $1.13 decreased 17%, in-line with expectations
Revenue of $7.4 billion decreased 8% as reported and 4% organic, ahead of expectations
Company reiterates FY23 revenue and EPS guidance
The company reported worldwide revenue of $7.371 billion, a decrease of 8% as reported and 4% on an organic basis. The organic comparison excludes a $351 million negative impact from foreign currency translation and a $20 million contribution from the company’s recent acquisition of Intersect ENT, which is reported in the Specialty Therapies division in the Neuroscience Portfolio. Unless otherwise stated, all revenue growth rates in this press release are on an organic basis, which excludes the impact of foreign currency translation and revenue from the Intersect ENT acquisition. The company’s first quarter organic revenue results reflect the impact of known supply chain shortages, as well as unfavorable comparisons to the prior year given last year’s strong ventilator sales and market procedure recovery following the third COVID-19 wave.

As reported, first quarter GAAP net income and diluted earnings per share (EPS) were $929 million and $0.70, respectively, increases of 22% and 25%, respectively. As detailed in the financial schedules included at the end of this release, first quarter non-GAAP net income and non-GAAP diluted EPS were $1.502 billion and $1.13, respectively, decreases of 18% and 17%, respectively. The company’s earnings reflect the continued impact to certain procedure volumes and the macroeconomic impacts of inflation and foreign currency translation.

First quarter U.S. revenue of $3.766 billion represented 51% of company revenue and decreased 8% as reported and 9% organic. Non-U.S. developed market revenue of $2.328 billion represented 32% of company revenue and decreased 10% as reported and increased 2% organic. Emerging Markets revenue of $1.276 billion represented 17% of company revenue and decreased 1% as reported and increased 2% organic.

"The company continues to execute in a challenging environment, delivering organic revenue above our guidance," said Geoff Martha, Medtronic chairman and chief executive officer. "As we look ahead, our supply chain is improving, we have several near-term pipeline catalysts approaching, and we are confident in our ability to accelerate growth."

Cardiovascular Portfolio
The Cardiovascular Portfolio includes the Cardiac Rhythm & Heart Failure (CRHF), Structural Heart & Aortic (SHA), and Coronary & Peripheral Vascular (CPV) divisions. Cardiovascular revenue of $2.713 billion decreased 6% as reported and 1% organic, with low-single digit declines in CRHF and CPV and flat year-over-year results in SHA, all on an organic basis.

Cardiac Rhythm & Heart Failure revenue of $1.393 billion decreased 6% as reported and 1% organic. Cardiac Rhythm Management revenue decreased low-single digits, with high-single digit declines in Defibrillation Solutions partially offset by mid-single digit growth in Cardiac Pacing Therapies, driven by mid-teens growth in Leadless Pacemakers from continued global adoption of Micra transcatheter pacing systems. Cardiovascular Diagnostics revenue increased low-single digits, as procedures remain under pressure market-wide. Cardiac Ablation Solutions revenue decreased low-single digits as a result of supply constraints in Western Europe, and COVID lockdowns in China.
Structural Heart & Aortic revenue of $741 million decreased 6% as reported and was flat year-over-year organic. Structural Heart decreased low-single digits, including low-single digit growth in transcatheter aortic valves (TAVR). Aortic declined mid-single digits given continued supply challenges. Cardiac Surgery increased mid-single digits, driven by strength in extracorporeal life support products and sales of the Avalus pericardial aortic surgical valve.
Coronary & Peripheral Vascular revenue of $579 million decreased 7% as reported and low-single digits organic. Coronary & Renal Denervation (CRDN) decreased mid-single digits, given the ongoing impact of COVID-19 on percutaneous coronary intervention (PCI) market procedures in many geographies. Peripheral Vascular Health decreased low-single digits, with declines in directional atherectomy and PTA balloons partially offset by growth in drug-coated balloons, vascular embolization, and superficial venous products.
Medical Surgical Portfolio
The Medical Surgical Portfolio includes the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions. Medical Surgical revenue of $2.001 billion decreased 14% as reported and 9% organic, with high-single digit declines in both SI and RGR. Excluding the impact of ventilator sales given the increased COVID-19 related demand in the prior year, Medical Surgical revenue decreased 7% organic.

Surgical Innovations revenue of $1.338 billion decreased 14% as reported and 9% organic. The division had low-double digit declines in Advanced Surgical Instruments given expected acute supply chain shortages of raw materials, and the impact of China COVID lockdowns and provincial value-based procurement (VBP) stapling tenders. These declines were partially offset by strength in Hernia & Wound Management, which increased mid-single digits.
Respiratory, Gastrointestinal & Renal revenue of $664 million decreased 14% as reported and 9% organic. RGR revenue decreased 3% organic excluding the impact of ventilator sales. Respiratory Interventions decreased mid-twenties, with sales of ventilators declining low-fifties as demand was well below pre-pandemic levels. Patient Monitoring increased low-single digits, with low-single digit declines in Nellcor pulse oximetry products offset by mid-single digit growth in Perioperative Complications products. Gastrointestinal revenue decreased low-single digits, with high-single digit declines in esophageal products partially offset by mid-single digit growth in chronic and colorectal products. Renal Care Solutions decreased low-double digits given product holds and supply chain challenges.
Neuroscience Portfolio
The Neuroscience Portfolio includes the Cranial & Spinal Technologies (CST), Specialty Therapies, and Neuromodulation divisions. Neuroscience revenue of $2.115 billion decreased 4% as reported and 2% organic, with mid-single digit declines in CST and Neuromodulation, partially offset by mid-single digit increases in Specialty Therapies, all on an organic basis.

Cranial & Spinal Technologies revenue of $1.043 billion decreased 7% as reported and 5% organic. Spine & Biologics decreased mid-single digits, with mid-teens declines in Biologics given customer ordering patterns, partially offset by mid-single digit Core Spine growth in the United States. Neurosurgery declined low-single digits, with declines in navigation and robotics partially offset by growth in powered surgical instruments, imaging, and CSF management.
Specialty Therapies revenue of $667 million increased 4% as reported and organic. Neurovascular increased low double-digits driven by strength in hemorrhagic stroke products. Pelvic Health decreased low-single digits on competitive pressures. ENT was flat year-over-year on an organic basis given supply constraints on several product lines.
Neuromodulation revenue of $405 million decreased 8% as reported and 5% organic. Brain Modulation decreased low-single digits, as significant declines of replacement devices were partially offset by increased share of initial implants from the continued adoption of the Percept PC deep brain stimulation (DBS) system and SenSight directional DBS lead system. Pain Therapies decreased high-single digits, with mid-single digit declines in both Interventional and Pain Stim, as well as low-double digit declines in Targeted Drug Delivery on a difficult comparison given a supply recovery in the prior year. The Pain Stim market remained under pressure given healthcare staffing challenges and higher payer pre-authorizations. At the same time, the company continued to win new implant share in Pain Stim on strong adoption of its Vanta and Intellis with DTM SCS neurostimulators.
Diabetes
Diabetes revenue of $541 million decreased 5% as reported and was flat year-over-year organic. U.S. revenue declined mid-teens, given the absence of new product approvals. This was offset by low-double digit organic growth in non-U.S. developed markets and mid-teens organic growth in emerging markets. International sales were driven by mid-twenties growth in sales of continuous glucose monitoring (CGM) products and low-double digit growth in consumable sales, offset by low-single digit declines in sales of durable insulin pumps.

Guidance
The company today reiterated its revenue growth and EPS guidance ranges for fiscal year 2023.

The company continues to expect organic revenue growth in its fiscal year 2023 in the range of 4% to 5%. If recent foreign currency exchange rates hold, fiscal year 2023 revenue growth would be negatively affected by approximately $1.4 billion to $1.5 billion versus the previously stated $1.0 to $1.1 billion impact.

The company continues to expect fiscal year 2023 diluted non-GAAP EPS in the range of $5.53 to $5.65, including an estimated 17 to 22 cent negative impact from foreign currency.

"While our markets are facing macroeconomic challenges, we’re focused on identifying ways to offset their impact to our financials," said Karen Parkhill, Medtronic chief financial officer. "Looking ahead, we expect organic revenue growth to improve each quarter, with the second half of the fiscal year much stronger than the first. We are optimistic about our future, as we create markets and realize new opportunities."

Webcast Information
Medtronic will host a webcast today, August 23, at 8:00 a.m. EDT (7:00 a.m. CDT) to provide information about its businesses for the public, investors, analysts, and news media. This webcast can be accessed by clicking on the Events icon at investorrelations.medtronic.com and this earnings release will be archived at news.medtronic.com. Medtronic will be live tweeting during the webcast on its Newsroom Twitter account, @Medtronic. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Events icon at investorrelations.medtronic.com.

Medtronic plans to report its fiscal year 2023 second, third, and fourth quarter results on November 22, 2022, February 21, 2023, and Thursday, May 25, 2023, respectively. Confirmation and additional details will be provided closer to the specific event.

Financial Schedules
The first quarter financial schedules and non-GAAP reconciliations can be viewed by clicking on the Investor Events link at investorrelations.medtronic.com. To view a printable PDF of the financial schedules and non-GAAP reconciliations, click here. To view the first quarter and fiscal year 2023 earnings presentation, click here.

On August 23, 2022 Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and clinical development in oncology, reported that the first patient has been dosed in the phase 1 clinical study (NCT05431270) of PT199, an anti-CD73 monoclonal antibody (mAb) for the treatment of multiple advanced solid tumors (Press release, Phanes Therapeutics, AUG 23, 2022, View Source [SID1234618586]).

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PT199 is an anti-CD73 mAb with a differentiated mechanism of action and is designed to counter the adenosine-mediated immunosuppressive tumor microenvironment (TME). PT199 fully inhibits both soluble and membrane-bound CD73, unlike some other CD73 inhibitors which exhibit incomplete inhibition. Moreover, at higher concentrations, no loss of inhibition or "hook effect" is observed with PT199. Hence, PT199 addresses the limitations of current CD73 inhibitors and is expected to increase antitumor immune activation, and potentially offer a new treatment option for cancer patients.

"The CD73 pathway represents a very promising target for addressing the immunosuppressive TME and we are pleased to open this study and bring this potential best-in-class mAb to cancer patients who have few treatment options." said Dr. Ming Wang, Founder and CEO of Phanes Therapeutics.

The multi-center Phase I clinical trial of PT199 is evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT199, alone and in combination with a PD-1 inhibitor, in patients with locally advanced or metastatic solid tumors that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate. Enrollment in the trial is open to individuals aged 18 years and older who have measurable disease with at least 1 lesion amenable to response assessment per RECIST 1.1 criteria, adequate organ function, and an ECOG performance status of 0 to 1.