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 Genosco reported its Yuhan’s Leclaza (ingredient: lazertinib), Korea’s 31st novel drug that treats lung cancer, has reached the commercialization stage, raising expectations for a new treatment option (Press release, Genosco, FEB 5, 2021, View Source [SID1234575420]).

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The drug received approval from the Ministry of Food and Drug Safety on Jan. 18, on the condition that the company submits phase-3 trial data after the market release.

Hospitals can use the drug for treating non-small cell lung cancer (NSCLC) patients with positive EGFR T790M (epidermal growth factor receptor threonine at amino acid position 790) mutation.

Researchers in the anticancer field predict a major change in the lung cancer prescription market, currently dominated by AstraZeneca’s Tagrisso (Ingredient: Osimertinib), as clinical results of Leclaza has shown that it can provide new options for NSCLC patients.

"In the clinical trials of existing third-generation EGFR TKI first-line treatments, the drug’s efficacy was lower in Asians compared to the non-Asians population," Professor Ahn Myung-ju at the Department of Hematology-Oncology at Samsung Medical Center said during a news conference on Friday. "Therefore, it was necessary to verify the efficacy of NSCLC drugs in Koreans, including Asians."

Ahn added that researchers believe that the approval of Leclaza will resolve such concerns and address the unmet demand for EGFR TKI (tyrosine kinase inhibitor) as the drug showed excellent effects in terms of resistance and brain metastasis, she added.

Professor Cho Byoung-chul of Yonsei Cancer Center, who participated in the Leclaza study as principal investigator, stressed the importance of Leclaza’s approval.

"Leclaza’s product license is good news for Yuhan and Korean patients and patients worldwide as well," Professor Cho said. "Leclaza is the only third-generation EGFR mutant therapeutic agent that has been on the same level in terms of effectiveness as Tagrisso."

He stressed that Leclaza’s approval is important because a Korean pharmaceutical company obtained approval for Korean patients.

Cho explained the mechanism, efficacy, and safety of Leclaza based on its non-clinical and clinical trials’ main results.

"Researchers have high expectations as compared to other EGFR TKI treatments, Leclaza has excellent selectivity in distinguishing between normal and mutant EGFR, and exhibits excellent effects on brain metastasis tumors," Cho said.

According to Cho, the LASER201 clinical trials showed that the objective response rate (ORR) according to the independent central review and investigator evaluation of 76 T790M mutation-positive patients is 78 patients assigned to the 240mg dose group was 58 and 72 percent. At the same time, the median progression-free survival was 11 and 13.2 months.

Researchers also observed drug-related adverse reactions of CTCAE (common terminology criteria for adverse events) grade 3 or higher in only 5 percent of the test subjects. At the same time, cardiac safety results were also excellent.

"As a result, we could confirm that Leclaza showed a significant therapeutic effect and safety profile as a second-line treatment for EGFR T790M mutation-positive NSCLC," Cho said. "Starting with the local approval, I hope that Leclaza will become a symbol of hope for lung cancer patients around the world as Yuhan plans to conduct a global phase 3 clinical trial."

According to a company official, Yuhan has almost completed recruiting participants for the global phase 3 clinical trial, despite the ongoing Covid-19 epidemic.

"We still need to recruit additional Westerners to participate in the trial, but have reached our goal to recruit patients in Asia," the official said.

On February 5, 2021 The Board of Jubilant Pharmova Limited reported to approve financial results for the quarter ended December 31st, 2020 (Press release, Jubilant Pharma, FEB 5, 2021, View Source [SID1234575193]).

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Commenting on the Company’s performance, Mr. Shyam S Bhartia, Chairman and Mr. Hari S Bhartia, CoChairman & Managing Director, Jubilant Pharmova said: "Q3’FY21 has witnessed a substantial improvement over the previous quarter despite continued adverse impact of the COVID-19 pandemic.

Pharma business delivered strong performance led by CDMO and Generics. We continue to see new business opportunities in CDMO, Generics and Specialty Pharma segments.

The company’s performance in the LSI business has been better due to good demand and improved pricing of select products.

Contract Research and Development Services business witnessed strong year-on-year growth in revenues led by healthy demand from customers.

We continue to expect strong performance in our businesses in Q4’FY21. During 9M’FY21, the Company reduced net debt on a constant currency basis by Rs 570 Crore. This is in addition to Rs 514 crore reduction in net debt during FY20.

We received the final NCLT order approving the demerger of our LSI business. The demerger is effective from February 1, 2021 and creates separate and focused entities: Jubilant Pharmova for pharmaceuticals, contract research and development services and proprietary novel drugs businesses and Jubilant Ingrevia for life science products and innovative solutions business; that will help in unlocking shareholder value."

Q3’FY21 Highlights
A. Consolidated
 Revenue at Rs 2,664 Crore, as compared with Rs 2,315 Crore in Q3’FY20; up 15% YoY
 Reported EBITDA at Rs 653 Crore as compared with Rs 513 Crore in Q3’FY20; up 27% YoY. EBITDA margin at 24.5% vs. 22.2% in Q3’FY20
 Finance costs at Rs 59 Crore vs. Rs 72 Crore in Q3’FY20
Net Profit at Rs 310 Crore versus Rs 203 Crore in Q3’FY20. EPS of Rs 19.5 vs. Rs 12.8 in Q3’FY20; up 52% YoY
 Capital expenditure for the quarter was Rs 104 Crore Jubilant Pharmova Limited 1A, Sector 16A, Noida – 201301, India Tel.: +91 120 4361000 www.jubilantpharmova.com Segment Wise Analysis B. Pharmaceuticals Segment
Pharmaceuticals revenue was at Rs 1,692 Crore vs. Rs 1,450 Crore in Q3’FY20
 Pharmaceuticals EBITDA recorded at Rs 499 Crore as compared with Rs 411 Crore in Q3’FY20 with a margin of 29.5% as compared to 28.4% in Q3’FY20
 R&D spent during the quarter of Rs 45 Crore – 2.6% to segment sales. R&D debited to P&L is Rs 47 Crore – 2.8% to segment sales
 CMO business’ revenue grew based on strong demand from customers as well as new deals
 Five separate clinical and commercial supply agreements for COVID-19 treatment and vaccine candidates signed in 9M’FY21. Remdesivir of Gilead approved by the US FDA has been contributing to CMO revenue growth
 Started contract manufacturing of Eli Lily’s Bamlanivimab, a drug that has been granted Emergency Use Authorization by the US FDA for treatment of COVID-19 and COVID-19 vaccine candidate NVX-CoV2373 of Novavax, biotechnology company developing next-generation vaccines for serious infectious diseases
 Revenue growth during the quarter was also led by strong performance in key products in Generics segment, especially in the US market and also by launch of Remdesivir in various countries including India C. Life Science Ingredients Segment
 LSI revenue was at Rs 893 Crore against Rs 797 Crore in Q3’FY20
 Strong growth witnessed in Nutrition and Health Solutions and Life Science Chemicals business driven by improved pricing in both the segments
 EBITDA at Rs 155 Crore increased by 55% YoY with margin of 17.4% as compared to 12.6% in Q3’FY20
 Strong improvement in profitability is driven by improvement in prices across several products as well as recovery in volumes in Nutrition and Life Sciences Chemicals D. Contract Research and Development Services Segment
 Revenue at Rs 79 Crore increased by 17% YoY
 Reported EBITDA at Rs 29 Crore vs. Rs 22 Crore in Q3’FY20 with a margin of 36.4% vs. 32.9% in Q3’FY20
 Higher demand from biotech companies for integrated services, functional chemistry and DMPK
 Company continues to witness strong demand conditions in this business 9M’FY21 Highlights E. Consolidated
 Consolidated Revenue at Rs 6,932 Crore vs. Rs 6,763 Crore in 9M’FY20
 EBITDA at Rs 1,457 Crore vs. Rs 1,438 Crore in 9M’FY20. EBITDA margin at 21.0% vs. 21.3% in 9M’FY20
 Finance costs at Rs 199 Crore down 8% YoY
 Net Profit at Rs 622 Crore vs. Rs 638 Crore in 9M’FY20. EPS of Rs 39.1 vs. Rs 40.0 in 9M’FY20  Capex of Rs 285 Crore in 9M’FY21
Net debt reduced by Rs 570 Crore during 9M’FY21 Segment Wise Analysis F. Pharmaceuticals Segment
Pharmaceuticals revenue at Rs 4,304 Crore vs. Rs 4,231 Crore in 9M’FY20
 EBITDA at Rs 1,020 Crore vs. Rs 1,127 Crore in 9M’FY20. Margin of 23.7% as compared to 26.6% in 9M’FY20 G. Life Science Ingredients Segment
 LSI revenue at Rs 2,413 Crore vs Rs 2,356 Crore in 9M’FY20
EBITDA at Rs 418 Crore up 34% YoY with margin of 17.3% as compared to 13.3% in 9M’FY20 H. Contract Research and Development Services Segment
 Revenues at Rs 211 Crore up 20% YoY
 EBITDA was at Rs 67 Crore up from Rs 52 Crore in 9M’FY20

I. Business Outlook
 We continue to see improvement in demand in most of our business segments be it CMO, Generics, API or Life Science Ingredients
 Given the strong demand recovery and new business sign-ups, we believe COVID-19 is not likely to have a material impact on our overall performance during FY21, provided the pandemic situation does not materially deteriorate going forward
 Overall, we continue to see strong performance in our businesses in Q4’FY21
 For Pharmaceutical business, we continue to see strong performance in Q4
 For LSI business, we expect to achieve close to double-digit revenue growth and significant growth in EBITDA with higher margin and a very healthy cash generation in FY21

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 argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, reported the closing of its previously announced global offering of an aggregate of 3,593,750 ordinary shares (including ordinary shares represented by American Depositary Shares (ADSs)), which includes the full exercise of the underwriters’ option to purchase 468,750 ordinary shares in the form of ADSs (Press release, argenx, FEB 5, 2021, View Source,aggregate%20of%203%2C593%2C750%20ordinary%20shares [SID1234574709]). The gross proceeds from the global offering were approximately $1.15 billion (approximately €954.8 million).

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J.P. Morgan, Morgan Stanley, BofA Securities and Cowen acted as joint bookrunning managers for the offering.

The securities were offered in the United States pursuant to an automatically effective shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC). A preliminary prospectus supplement relating to the securities was filed with the SEC on February 1, 2021 and a final prospectus supplement relating to the securities was filed with the SEC on February 4, 2021 and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the U.S. offering may be obtained for free from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attn: Prospectus Department, by email at [email protected], or by telephone at (866) 718-1649; from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, North Carolina 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected], or by telephone at (833) 297-2926.

In addition, argenx announces the listing of and the commencement of dealings in its 3,593,750 new ordinary shares on the regulated market of Euronext Brussels.

This press release is for information purposes only and does not constitute, and should not be construed as, an offer to sell or the solicitation of an offer to buy or subscribe to any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale is not permitted or to any person or entity to whom it is unlawful to make such offer, solicitation or sale. Reference is also made to the restrictions set out in "Important information" below. This press release is not for publication or distribution, directly or indirectly, in or into any state or jurisdiction into which doing so would be unlawful or where a prior registration or approval is required for such purpose.