On February 5, 2021 Kureha Corporation reported that FY2020 3Q Results (Press release, Kureha Corporation, FEB 5, 2021, View Source [SID1234574710])

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I. Highlights
FY2020 3Q results (year-on-year analysis)
• Delivered core operating profit of ¥14.6bn (+12.1%, ¥1.6bn) driven by PVDF (LiB binder applications), agrochemicals, home products, fishing lines and environmental businesses; lower fuel and raw materials cost; and fewer SG&A expenses • Operating profit decreased to ¥14.6bn (-43.5%, ¥11.2bn) for the absence of other income such as a gain from land sales

✓ Limited impact of the coronavirus pandemic on sales and production operations
✓ Advanced Materials: continued demand for PVDF in automotive LiB binder applications in EU and China; PGA frac plug volumes improved with new flexible prices while shale fracking activities gradually returned with crude oil prices going over $50/bbl
✓ Specialty Plastics: continued robust sales of home products and fishing lines; slower demand for multilayer shrink film in EU; negative effects of business divestment related to blow bottles
FY2020 full-year outlook

• Upgraded FY2020 guidance based on higher sales volumes expected in Advanced Materials and environmental businesses and less-than-expected SG&A expenses Current guidance Previous guidance ChII. FY2020 3Q Results (Period April 1, 2020 – December 31, 2020) Revenue improved primarily due to higher sales volumes in Other Operations, partially offset by Specialty Plastics

• Core operating profit grew in all segments except Advanced Materials
• Operating profit decreased due largely to fewer non-operating income such as a gain from land sales
• Profit attributable to the Company decreased as a result of lower operating profit and lower profit before taxesAM: Lower profit led by PPS, PGA and carbon products, partially offset by improved PVDF performance SC: Higher profit driven by agrochemicals and pharmaceuticals despite a decline in industrial chemicals SP: Higher profit driven by home products and fishing lines despite a decline in packaging materials CO: Profit even with prior year due to project cancellations/postponements in private sector offsetting higher civil engineering volumes OO: Higher profit driven by volume growth related to low-level PCB waste treatment and 2019 typhoon disaster wastes in Fukushima in the environmental engineering business Revenue Operating profit Segment results FAdvanced plastics PPS: Profit declined on lower sales volumes for automobile applications and lower equity income in affiliates PVDF: Higher profit driven by volume growth for LiB binder applications, partially offset by declines in other applications PGA: Profit down due to declined sales of frac plugs and stock shapes, although shale drilling activities gradually returned in 3Q Carbon products Lower profit led by slower carbon fiber sales for automobile and furnace insulation applications Other Profit improved on higher adhesive volumesVs.

FY2019 3Q Revenue Operating Profit 9 Agrochemicals Higher profit driven by fungicides volume growth Pharmaceuticals Profit improved on lower expenses, despite sales negatively affected by mandatory drug price revisions Industrial chemicals Profit down due to slower demand for organic and inorganic chemicals amid COVID-related slumpVs.

FY2019 3Q Revenue Operating Profit 10 Home products / Fiber products Profit growth driven by higher home products and ‘Seaguar’ fishing lines volumes Packaging materials Sales and profit declined due to slower demand for heat-shrink multilayer film for meat packaging in EU under the pandemic, coupled with negative effects of the blowbottle business divested in prior yearConstruction Revenue declined and profit remained on par with prior year as higher civil engineering sales volumes offset the cancellation and postponement of privatesector construction Environmental engineering Profit increased on higher volumes of lowlevel PCB wastes and 2019 typhoonrelated disaster wastes in Fukushima Logistics Revenue and profit remained at prior year’s levels Hospital operations Revenue and profit decreasedIII.

FY2020 Full-Year Outlook (Period April 1, 2020 – March 31, 2021)Revenue expected to decrease due to:-Slower demand for PGA in the shale market-Effects of the bottle business divestment-Slower demand for industrial chemicals partly offset by-Higher PVDF volume for LiB binder applications-Sales expansion in the environmental business

• Core operating profit to increase on volume growth of value-added products such as PVDF and environmental services, partially offset by declines in PGA, packaging materials and industrial chemicals
• Operating profit to decline primarily due to the absence of other income such as a gain from land sales
• Profit before taxes to decrease on lower operating profit
• Profit attributable to the Company to decrease on lower profit before taxesFactors attributing to operating profit (vs. FY2019) Advanced Materials Specialty Chemicals Specialty Plastics Construction Other Operations Advanced Materials Specialty Chemicals Specialty Plastics Construction Other Operations (in billions of yen) AM: Operating loss for PGA, partially offset by higher PVDF volume SC: Improved demand for agrochemicals after prior year’s inventory adjustments SP: Higher fishing line sales volume offset by volume declines in packaging materials CO: Fewer high-margin projects, intensified market competition OO: Higher treatment volumes related to low-level PCB wastes and Fukushima’s typhoon disaster wastesFactors attributing to operating profit (vs. previous guidance) Advanced Materials Specialty Chemicals Specialty Plastics Construction Other Operations Advanced Materials Specialty Chemicals Specialty Plastics Construction Other Operations (in billions of yen) AM: Higher PVDF volumes for automotive LiB binder applications; no change for PGA SC: (No change) SP: Improved product mix for home products and lower expenses CO: (No change) OO: Higher treatment volumes of low-level PCB wastes and Fukushima typhoon disaster wastesIV. SupplementaryShale oil and gas production decreased sharply during 2020, but drilling and fracking operations are gradually returning in key markets

• Kureha’s sales expansion strategy:-Increase sales volumes of PGA frac plugs by offering flexible prices in mid-and hightemperature well areas-Introduce and expand sales of non-PGA dissolvable frac plugs in extremely low temperature areas (currently under field trials)
• Kureha maintains a roughly 40% share in the automotive LiB cathode binder market; supplies to major South Korean and Chinese lithium-ion battery (LiB) makers
• After COVID-related disruption for LiB production in early 2020, the market is rapidly recovering on the back of tighter environmental regulations and economic stimulus policies
• Kureha’s China plant started production and shipment of specialty binder grade of PVDF in May 2020
• Studies for a new PVDF plant under review (delayed due to the pandemic):-To be located in China-Outlines of the new plant to be announced by Spring 2021-Will start commercial production in FY2024These materials are supplied to provide a deeper understanding of our company, and are not intended to as a solicitation for investment or other actions.
• These materials have been prepared by our company based on the information available at this point in time. However, actual performance may produce results that differ from the plan due to unforeseeable events and factors.
• Please utilize these materials using you own judgment and responsibility.

On February 5, 2021 I-Mab (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics, reported multiple clinical advancements for its proprietary and highly differentiated CD73 antibody, uliledlimab (also known as TJD5, or TJ004309) in advanced solid tumors (Press release, I-Mab Biopharma, FEB 5, 2021, View Source [SID1234574676]). The Company plans to present detailed clinical results at select scientific conferences this year.

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CD73 is implicated in tumor resistance to checkpoint immunotherapies as it plays a critical role in adenosine-mediated immune suppression in tumor microenvironment. Uliledlimab is a humanized CD73 antibody and works effectively on modulating tumor microenvironment through inhibition of the adenosine pathway. Uliledlimab is shown to strongly suppress tumor growth especially when combined with a PD-(L)1 inhibitor in pre-clinical studies. As a differentiated CD73 antibody, uliledlimab interacts with a unique epitope to function through a novel intra-dimer binding mode, thus enabling differentiated and favorable functional properties. Detailed data from the pre-clinical and mechanistic studies have been submitted for presentation at the upcoming American Association of Cancer Research Annual Meeting.

I-Mab has made significant progress in the global clinical development of uliledlimab. In China, I-Mab is advancing the phase 1/2 dose escalation and cohort expansion study of uliledlimab as a single agent and in combination with toripalimab (TUOYI) in patients with advanced or metastatic cancers who are refractory to or intolerant of available therapies. On February 3, 2021, the first patient in the combination study was dosed.

In the U.S., I-Mab has completed the initial assessment of its clinical study investigating uliledlimab monotherapy lead-in followed by combination with atezolizumab (Tecentriq) in patients with solid tumors. Topline results from a clinical study under contract with TRACON show that uliledlimab is safe and well tolerated at the dose range evaluated and demonstrate clinical activity in patients with advanced solid tumors. The Company is scheduled to submit an abstract to ASCO (Free ASCO Whitepaper) for the 2021 annual meeting.

"We are encouraged and very pleased by the clinical results and overall advancements of uliledlimab in both China and the U.S.," said Dr. Joan Shen, CEO of I-Mab. "We believe that the combination of uliledlimab with immune checkpoint inhibitors, such as toripalimab or atezolizumab, has the potential to offer a novel treatment option with intended clinical benefit in cancer patients who do not or poorly respond to current checkpoint immunotherapies."

About Uliledlimab (TJD5)

Uliledlimab (TJD5) is a differentiated, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. Adenosine in turn binds to adenosine receptors on relevant immune cells and inhibits anti-tumor immune responses in tumor microenvironment. Uliledlimab is expected to offer clinical benefit by suppressing tumor growth in concert with checkpoint therapies such as PD-1 and PD-(L)1 antibodies. Uliledlimab is effective in anti-tumor activities through a unique intra-dimer binding, leading to differentiated and favorable functional properties as evident in preclinical studies.

On February 5, 2021 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company, reported that China National Medical Products Administration (NMPA) has approved the clinical trial of Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib in combination with R-CHOP for previously untreated patients with mantle cell lymphoma (MCL) (Press release, InnoCare Pharma, FEB 5, 2021, View Source [SID1234574692]).

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This is a phase 3 multicenter, randomized trial of orelabrutinib in combination with R-CHOP versus placebo plus R-CHOP in previously untreated MCL patients. The primary endpoint of the study is progression-free survival (PFS), and secondary endpoints include overall response rate (ORR), duration of response (DOR), and overall survival (OS). In addition, orelabrutinib combined with R-CHOP will also be used to treat patients with other B-cell malignant lymphomas.

Orelabrutinib is a highly selective BTK inhibitor targeting both B-cell lymphomas and autoimmune indications. On December 25, 2020, orelabrutinib received approval from the NMPA in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and the treatment of patients with relapsed/refractory MCL. On Dec. 31, 2020, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to orelabrutinib for treatment of MCL.

MCL is typically an aggressive form of non-Hodgkin’s lymphoma (NHL) that arises from B-cells originating in the "mantle zone." Last December, clinical data presented at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrated that the treatment of relapsed or refractory MCL with orelabrutinib resulted in an 87.9% ORR and a 93.9% disease control rate. The CR rate, by conventional CT method, reached 34.3%.

Dr. Jasmine Cui, the co-founder, Chairwoman and CEO of InnoCare said, "Orelabrutinib is the focus of multi-center and multi-indication clinical trials in China and the U.S. In addition to CLL/SLL and MCL, we are actively exploring other tumors and autoimmune disease. It has always been our top priority to target diseases with urgent, unmet needs."

On February 5, 2021 Isofol reported that an abstract has been approved for presentation at the virtual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Congress 2021 (Press release, Isofol Medical, FEB 5, 2021, View Source [SID1234576711]). The congress will take place during April 10-15, 2021 and a poster will be presented on April 10.

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On February 5, 2021 Pfizer Inc. (NYSE: PFE) reported that the U.S. Patent and Trademark Office (USPTO) recently issued a U.S. Patent Term Extension (PTE) certificate for IBRANCE (palbociclib) (Press release, Pfizer, FEB 5, 2021, View Source [SID1234574693]). The certificate extends the term of U.S. Patent No. RE47,739 (‘739) by more than four years until March 5, 2027. The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984.

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This PTE will be listed in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book), published by the U.S. Food and Drug Administration (FDA). This extension does not include potential pediatric exclusivity.

About IBRANCE (palbociclib) 125 mg tablets and capsules

IBRANCE is an oral inhibitor of CDKs 4 and 6,1 which are key regulators of the cell cycle that trigger cellular progression.2,3 In the U.S., IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy.

IBRANCE is currently approved in more than 100 countries and has been prescribed to more than 350,000 patients globally.

The full U.S. Prescribing Information for the IBRANCE tablets and the IBRANCE capsules can be found here and here.

IMPORTANT IBRANCE (palbociclib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION

Neutropenia was the most frequently reported adverse reaction in PALOMA-2 (80%) and PALOMA-3 (83%). In PALOMA-2, Grade 3 (56%) or 4 (10%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole. In PALOMA-3, Grade 3 (55%) or Grade 4 (11%) decreased neutrophil counts were reported in patients receiving IBRANCE plus fulvestrant. Febrile neutropenia has been reported in 1.8% of patients exposed to IBRANCE across PALOMA-2 and PALOMA-3. One death due to neutropenic sepsis was observed in PALOMA-3. Inform patients to promptly report any fever.

Monitor complete blood count prior to starting IBRANCE, at the beginning of each cycle, on Day 15 of first 2 cycles and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.

Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with CDK4/6 inhibitors, including IBRANCE when taken in combination with endocrine therapy. Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3 or 4, and no fatal cases were reported. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported.

Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnea). In patients who have new or worsening respiratory symptoms and are suspected to have developed pneumonitis, interrupt IBRANCE immediately and evaluate the patient. Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis.

Based on the mechanism of action, IBRANCE can cause fetal harm. Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise male patients to consider sperm preservation before taking IBRANCE. Advise male patients with female partners of reproductive potential to use effective contraception during IBRANCE treatment and for 3 months after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy. Advise women not to breastfeed during IBRANCE treatment and for 3 weeks after the last dose because of the potential for serious adverse reactions in nursing infants.

The most common adverse reactions (≥10%) of any grade reported in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (80% vs 6%), infections (60% vs 42%), leukopenia (39% vs 2%), fatigue (37% vs 28%), nausea (35% vs 26%), alopecia (33% vs 16%), stomatitis (30% vs 14%), diarrhea (26% vs 19%), anemia (24% vs 9%), rash (18% vs 12%), asthenia (17% vs 12%), thrombocytopenia (16% vs 1%), vomiting (16% vs 17%), decreased appetite (15% vs 9%), dry skin (12% vs 6%), pyrexia (12% vs 9%), and dysgeusia (10% vs 5%).

The most frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (66% vs 2%), leukopenia (25% vs 0%), infections (7% vs 3%), and anemia (5% vs 2%).

Lab abnormalities of any grade occurring in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were decreased WBC (97% vs 25%), decreased neutrophils (95% vs 20%), anemia (78% vs 42%), decreased platelets (63% vs 14%), increased aspartate aminotransferase (52% vs 34%), and increased alanine aminotransferase (43% vs 30%).

The most common adverse reactions (≥10%) of any grade reported in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%).

The most frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (66% vs 1%) and leukopenia (31% vs 2%).

Lab abnormalities of any grade occurring in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were decreased WBC (99% vs 26%), decreased neutrophils (96% vs 14%), anemia (78% vs 40%), decreased platelets (62% vs 10%), increased aspartate aminotransferase (43% vs 48%), and increased alanine aminotransferase (36% vs 34%).

Avoid concurrent use of strong CYP3A inhibitors. If patients must be administered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor. Grapefruit or grapefruit juice may increase plasma concentrations of IBRANCE and should be avoided. Avoid concomitant use of strong CYP3A inducers. The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced as IBRANCE may increase their exposure.

For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis.