On January 28, 2022 Nanjing Bioheng Biotech Co., Ltd. ( hereinafter referred to as Bioheng) reported that its anti-claudin 18.2 autologous CAR-T cell therapy product CTB001 received Orphan Drug Designation (ODD) from the Food and Drug Administration (FDA) for the treatment of gastric cancer (Press release, Bioheng Biotech, JAN 28, 2022, View Source;t-product-received-orphan-drug-designation-odd-from-the-us-fda-301470432.html [SID1234607490]). Gastric cancer has a high incidence in Asian countries such as China and Japan, and the mortality rate ranks the third in the global mortality rate of malignant tumors, behind lung cancer and colorectal cancer. At present, conventional chemotherapy and surgical resection are mainly applied for the gastric cancer treatment, therefore the treatment drugs and methods are very limited.

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About CTB001:

Claudin18.2 is a pan-cancer target and is abnormally expressed in various primary tumors and metastases, including gastric cancer, pancreatic cancer, cholangiocarcinoma, ovarian cancer and lung adenocarcinoma. CTB001 is a fourth-generation autologous CAR-T cell therapy product targeting claudin18.2, which uses Bioheng Explored CAR-T platform technology to enhance the anti-tumor efficacy of the product.

The breakthrough of CAR-T therapy provides a new solution for cancer treatment, with high unmet clinical needs. CTB001 shows excellent efficacy and safety in exploratory clinical studies, and provides strong data support for the upcoming domestic declaration.

Bioheng indicates:

CTB001 is the first clinical validation of Bioheng Explored CAR-T platform technology. It is a very promising immunotherapy that can accurately, quickly and efficiently bring good benefits to claudin18.2-positive cancer patients.

The qualification of CTB001 obtained by FDA for orphan drugs will further accelerate the development and commercialization of cell and gene therapy, and promote Bioheng to enter the global innovative drug market. In the future, we look forward to bringing more products to clinical trials and providing more choices for solving the unmet medical needs.

About ODD:

The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the US or meets cost recovery provisions of the act. After obtaining the ODD, pharmaceutical companies could receive various incentives for the drug development, including 25% federal tax credit for expenses incurred in conducting clinical research within the United States, Waiver of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs, qualified to compete for research grants from the Office of Orphan Products Development (OOPD) to support clinical studies for orphan drugs, eligibility to receive regulatory assistance and guidance from the FDA in the design of an overall drug development plan and 7-year marketing exclusivity.

On January 28, 2022 Eli Lilly and Company (NYSE: LLY) reported that plans to invest over $1 billion to create a new manufacturing site, along with nearly 600 new jobs in Concord, North Carolina (Press release, Eli Lilly, JAN 28, 2022, View Source [SID1234607475]). The brand-new facility will utilize the latest technology to manufacture parenteral (injectable) products and devices and increase the company’s manufacturing capacity.

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"Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world," said Edgardo Hernandez, senior vice president and president, Lilly Manufacturing Operations. "Expanding our manufacturing footprint in North Carolina enables us to continue to produce today’s medicines while providing additional capacity to manufacture the medicines of tomorrow. We are pleased to again partner with North Carolina to bring jobs to American workers and provide more medicines that patients need to address health challenges."

Lilly selected Concord because of the manufacturing technology experience of the local labor force; its proximity to universities with strong science, technology, engineering and math (STEM) programs; and its access to major transportation infrastructure. In 2020, Lilly announced a $470 million investment in North Carolina’s Research Triangle Park. In conjunction with this site, the new facility in Concord will allow the company to strengthen relationships with local governments and universities and diversify its growing presence in the state.

Lilly plans to create nearly 600 new jobs for highly skilled workers such as scientists, engineers and manufacturing personnel, who will use advanced technology to produce life-changing treatments and devices to make life better for people around the world. In addition, an estimated 500 additional positions will be required while the facility is under construction.

"Lilly’s choice brings more good jobs to North Carolina from one of our most important industries," said North Carolina Governor Roy Cooper. "North Carolina has become a premier hub for the world, thanks to our exceptional workforce and commitment to education."

Over the last five years, Lilly has invested over $4 billion in global manufacturing, including more than $2 billion in the U.S. The company also reported plans to invest $500 million in a new biopharmaceutical manufacturing facility in Limerick, Ireland. Lilly anticipates additional future investments in manufacturing to address growth expected from potential new medicines to treat diabetes, Alzheimer’s disease, cancer and autoimmune conditions.

The investment in Concord is contingent upon completion of county and municipal government permitting and related approvals. Lilly partnered with several organizations throughout the project, including the Office of the Governor, the Department of Commerce, Cabarrus Economic Development Corporation, the City of Concord, Cabarrus County, the Economic Development Partnership of North Carolina, the North Carolina Biotechnology Center, Rowan Cabarrus Community College, and the North Carolina Community College System.

On January 28, 2022 Roche reported that it will publish its Full Year Results for 2021 prior to the opening of the Swiss Stock Exchange on Thursday, 3 February 2022 (Press release, Hoffmann-La Roche, JAN 28, 2022, View Source [SID1234607476]).

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On January 27, 2022 Redx (AIM:REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that audited financial results for the year ended 30 September 2021, as well as an operational update (Press release, Redx Pharma, JAN 27, 2022, View Source [SID1234607428]).

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Lisa Anson, Chief Executive Officer of Redx, commented:
"During the period, we have made strong progress in advancing our pipeline. Our lead oncology asset, RXC004, entered a Phase 2 clinical trial and our lead fibrosis asset, RXC007, entered a Phase 1 clinical trial. Our discovery pipeline of differentiated programmes continues to progress driven by the strength of our science and validated by milestone revenue increasing during the year. We are in a position to deliver meaningful results in the clinic which could drive benefits for patients and value for shareholders."

Operational Highlights
· Significant clinical progress on lead oncology asset, RXC004, an oral, potent, selective, small molecule Porcupine inhibitor product candidate:
o Completed monotherapy module of Phase 1 trial showing differentiated level of activity in Wnt-ligand dependent tumours; o Presented Phase 1 data at theEuropean Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress; o Selected 2 mg as recommended dose for monotherapy Phase 2 studies;
o Post period, initiated Phase 2 trial in monotherapy treatment in genetically selected MSS metastatic colorectal cancer, with US IND now open (PORCUPINE trial); and o Post period, initiated second Phase 2 trial in monotherapy treatment in genetically selected pancreatic cancer and unselected biliary cancer (PORCUPINE2 trial). · Initiated Phase 1 clinical trial in healthy volunteers for RXC007, an orally bioavailable selective Rho Associated Protein Kinase 2 (ROCK2) inhibitor with potential for development in multiple fibrotic conditions:
o Post period, reported interim Phase 1 safety, tolerability and pharmacokinetic (PK) data on11 October 2021 showing no adverse events and an attractive PK profile. · Progressed discovery portfolio, including our Discoidin Domain Receptor (DDR) inhibitor fibrosis programme:
o Developed potent proprietary DDR inhibitors with drug-like characteristics that are now in lead optimisation. · Increased milestone revenue from progress of partnered programmes: o Milestones totalling $7 million received from AstraZeneca ($4 million related to RXC006) and Jazz Pharmaceuticals ($3 million related to Pan-RAF) during the period; o Revenue from the Jazz Pharmaceuticals collaborations received during the year for the progress on research programmes;
o Post period, on9 December 2021 Redx announced a $10 million milestone was earned from Jazz Pharmaceuticals for the progress in ongoing research collaboration and on 23 December 2021 Redx announced a $9 million milestone was earned from AstraZeneca as RXC006 entered clinical trials.

· Further strengthened the Redx management team and Board of Directors reflecting the transformation of the company into a clinical stage organisation: o Appointment of experienced key senior management-DrJane Robertson as Chief Medical Officer andPeter Collum as US-based Chief Financial Officer; o Creation of new role of Chief Operating Officer to be held byJames Mead and General Counsel role held byClaire Solk, who joined Redx on 17 January 2022 from her previous role as Senior Legal Counsel at AstraZeneca; o Board appointments of Natalie Berner in May 2021 as Non-Executive Director and DrJane Griffiths in December 2021 as new Chair, following the departure of Iain Ross in June 2021.

Financial Highlights
· Placing and Open Offer inDecember 2020 of £25.7 million (gross), which received strong support from existing investors and added healthcare specialist investors including Polar Capital; · Cash balance at30 September 2021 of £29.6 million (30 September 2020: £27.5 million);
· Total revenue for the year of£10.0 million (2020: £5.7 million); o Including milestone payments of $4 million from AstraZeneca, and $3 million from Jazz Pharmaceuticals;
· Loss for the year of£21.5 million (2020: £9.2 million);
· Total R&D expenditure of £24.4 million (2020: £10.5 million); · Cash balance funds operations through calendar year 2022.

For the purposes of MAR, the person responsible for arranging for the release of this announcement on behalf of Redx iAsndrew Booth, Company Secretary

On January 27, 2022 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that it has priced its previously announced offering of $1.0 billion aggregate principal amount of 6.125% senior secured notes due 2027 (the "Notes") (Press release, Bausch Health, JAN 27, 2022, View Source [SID1234607460]). The Notes will be sold to investors at a price of 100% of the principal amount thereof.

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As previously announced, the Company is also seeking to refinance its existing credit agreement (the "Credit Agreement" and such refinancing, the "Credit Agreement Refinancing"). The refinanced Credit Agreement is expected to consist of approximately $2.5 billion of term B loans (the "New Term B Loans") and a $975 million revolving credit facility. The Credit Agreement Refinancing is expected to occur upon completion of the initial public offering ("IPO") of Bausch + Lomb Corporation ("Bausch + Lomb" and such offering, the "Bausch + Lomb IPO") and a related debt financing by Bausch + Lomb (the "Bausch + Lomb Debt Financing").

The proceeds from the offering of the Notes, along with the expected proceeds from the New Term B Loans, the Bausch + Lomb IPO and the repayment of an intercompany note owed to us by Bausch + Lomb (which repayment is expected to be funded by the Bausch + Lomb Debt Financing), are expected to be used to fund the Company’s previously announced conditional redemption in full of its outstanding 6.125% Senior Notes due 2025 (the "6.125% Notes due 2025"), refinance all of the existing Term B Loans, fund the Company’s previously announced conditional partial redemption of its outstanding 9.000% Senior Notes due 2025 (the "9.000% Notes due 2025 and, collectively with the 6.125% Senior Notes due 2025, the "Existing Notes") and to pay related fees, premiums and expenses.

The Notes will be guaranteed by each of the Company’s subsidiaries that are guarantors under the Credit Agreement and existing senior notes and will be secured on a first priority basis by liens on the assets that secure the Credit Agreement and existing senior secured notes.

The Notes will not be registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities law and may not be offered or sold in the United States absent registration or an applicable exemption from registration under the Securities Act and applicable state securities laws. The Notes will be offered in the United States only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act and outside the United States to non-U.S. persons pursuant to Regulation S under the Securities Act. The Notes have not been and will not be qualified for sale to the public by prospectus under applicable Canadian securities laws and, accordingly, any offer and sale of the Notes in Canada will be made on a basis, which is exempt from the prospectus requirements of such securities laws.

The redemption of the 6.125% Notes due 2025 is conditioned upon the completion of the Credit Agreement Refinancing (the "6.125% Notes Condition"). The Company intends to discharge the indenture governing the 6.125% Notes due 2025 concurrently with satisfying such 6.125% Notes Condition. The partial redemption of the 9.000% Notes due 2025 is conditioned upon the receipt of aggregate gross proceeds from the Bausch + Lomb IPO, the Bausch + Lomb Debt Financing, the Credit Agreement Refinancing and the offering of the Notes of at least $7.0 billion (the "9.000% Notes Condition" and, together with the 6.125% Notes Condition, the "Conditions"). This announcement does not constitute an offer to purchase or the solicitation of an offer to sell the Existing Notes.

This news release is being issued pursuant to Rule 135c under the Securities Act and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.