On April 24, 2019 EpimAb Biotherapeutics, an emerging biopharmaceutical company based in Shanghai, reported that the United States Patent and Trademark Office (USPTO) has granted the U.S. Patent No. 10,266,608 entitled "Fabs-In-Tandem Immunoglobulin and Uses Thereof" (Press release, EpimAb Biotherapeutics, APR 24, 2019, View Source [SID1234535333]). Based on EpimAb’s globally filed first application, this patent broadly covers bispecific antibodies obtained utilizing the company’s FIT-Ig technology in a composition of matter claim.

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"This patent underscores the novelty of EpimAb’s approach in bispecific antibody generation and forms an important foundation of EpimAb’s growing IP portfolio," said Dr. Chengbin Wu, Founder and CEO of EpimAb Biotherapeutics. "The first granted patent in a major pharmaceutical market like the US therefore represents a significant milestone for EpimAb and takes us another step towards our goal to become a leading innovator in cancer biologics."

EpimAb is developing multiple programs based on its FIT-Ig platform for the treatment of various cancers. Its most advanced product candidate EMB-01, a cMet/EGFR bispecific with a novel mechanism of action was discovered and rapidly developed to the clinic by EpimAb. It is currently being investigated in a clinical Phase I/II trial in the USA and China. A second FIT-Ig molecule is currently under preclinical development with further molecules following soon, rapidly growing EpimAb’s pipeline of bispecific antibodies.

On April 24, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the first quarter of the fiscal year ended December 31, 2019 (Press release, Chugai, APR 24, 2019, View Source [SID1234535351]).

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Chugai reported record high revenues and profits for the first quarter of 2019 driven by contribution from new products including the hemophilia A treatment Hemlibra and the immune checkpoint inhibitor Tecentriq, and strong growth of mainstay products in Japan and overseas. Revenues increased by a little less than 5% as the double-digit sales growth driven mainly by the contribution of new products and strong exports outweighed the remarkable decrease in royalties and other operating income in the absence of one-time income from the transfer of long-term listed products reported last year. Operating profit achieved a double-digit increase due to a better cost to sales ratio as the proportion of in-house products increased in the total product mix.

Domestic sales increased to ¥99.3 billion (+6.9%). Contribution from new products including the hemophilia A treatment Hemlibra created by Chugai and the immune checkpoint inhibitor Tecentriq, and the strong growth of mainstay products chiefly in bone and joint diseases area have exceeded the negative impact from the NHI drug price revisions last year and generic competition.
Oncology: Sales increased driven by the contribution from new products such as Tecentriq and Gazayva as well as solid growth of Perjeta and Alecensa, despite the negative impact from last year’s NHI drug price revisions and generic competition facing Rituxan.
Bone and joint diseases: Sales recorded a double-digit growth due to strong sales of mainstay products such as the anti-rheumatic agent Actemra and the osteoporosis agent Edirol.
Renal diseases: Sales were almost flat while sales of the renal anemia agent Mircera and the secondary hyperparathyroidism treatment Oxarol approximated the previous year’s level.
Others: Sales increased primarily due to favorable market penetration of new products such as the hemophilia A treatment Hemlibra, despite the negative impact from the transfer of long-term listed products last year.
Overseas sales increased to ¥38.4 billion (+20.4%) due to increase in exports of Alecensa and Actemra to Roche.
Royalties and other operating income decreased to ¥16.6 billion (-26.9%) due to a decrease in other operating income in the absence of one-time income from the transfer of long-term listed products reported last year, despite royalties and profit sharing income related to Hemlibra increased.
Billion JPY Q1 2019 Q1 2018 % change
Sales 137.7 124.7 +10.4%
Domestic sales 99.3 92.9 +6.9%
Oncology 52.0 48.6 +7.0%
Bone and joint diseases 24.2 21.6 +12.0%
Renal diseases 7.9 8.0 -1.3%
Others 15.2 14.6 +4.1%
Overseas sales 38.4 31.9 +20.4%
[Core operating profit]
Core gross profit increased to ¥90.6 billion (+8.0%) due to sales growth and the better cost to sales with a higher proportion of in-house products in the total product mix, despite the remarkable decrease in royalties and other operating income.
Core operating expenses grew by a low single-digit percentage to ¥42.7 billion (+3.9%), more modestly than the growth in Core gross profit. As a result, Core operating profit totaled ¥47.9 billion (+11.9%).

On April 23, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported that the first patient in China has been successfully dosed in a Phase I clinical trial of a recombinant fully human bispecific antibody targeting programmed cell death receptor-1 (PD-1) and programmed cell death ligand-1 (PD-L1) (IBI318), an innovative antibody developed in collaboration with Eli Lilly and Company (Press release, Innovent Biologics, APR 23, 2019, View Source [SID1234535334]).

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CIBI318A101 is a Phase I clinical study conducted in China to evaluate IBI318 in the treatment of patients with advanced malignancies. The primary objectives of the study are to evaluate the safety, tolerability, and initial efficacy of IBI318.

IBI318 is a recombinant fully human IgG1 bispecific antibody targeting PD-1 and PD-L1, and may offer a novel solution to patients’ unmet medical needs. IBI318 simultaneously binds to PD-1 and PD-L1, blocks PD-1 and PD-L1 signaling, bridges PD-1-expressing T cells to PD-L1-expressing tumor cells, and enhances the formation of immune synapses, thereby potentially enhancing anti-tumor activities and increased anti-tumor efficacy.

"Immunotherapies such as checkpoint-blocking antibodies targeting PD-1 and PD-L1 are playing increasingly important roles in oncology therapy. However, there are still many challenges in their clinical application. Particularly, for patients without predictive biomarkers, the clinical response rate is approximately 20%. Many patients also have primary or acquired resistance to anti-PD-1/PD-L1 antibodies. We still need to actively develop the next generation of immunotherapy. We are looking forward to seeing the clinical results of IBI318," said Professor Xu Ruihua, Director of Sun Yat-Sen University Cancer Center.

"IBI318 is the world’s first PD-1/PD-L1 bispecific antibody to enter clinical development. Therefore, the development of IBI318 has unique clinical value. We will evaluate the potential clinical value of this drug candidate and hope to provide a more effective treatment option and ultimately benefit more patients," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.

About IBI318

IBI318, was discovered through the collaboration between Innovent and Eli Lilly and Company and has been developed in China by Innovent. IBI318 is a recombinant fully human immunoglobulin bispecific antibody that blocks both PD-1 binding to PD-L1 and PD-L2 and PD-L1 binding to CD80, which will restore T cell activation and generate anti-tumor activities. In preclinical studies, PD-1-expressing T cells and PD-L1-expressing tumor cells can be bridged by IBI318, which enhances immune synapse formation and anti-tumor activities. The cell bridging induced by IBI318 could further enhance the anti-tumor activities generated through modulating the PD-1/PD-L1 signaling pathway.

About CIBI318A101

CIBI318A101 is a Phase I clinical study conducted in China to evaluate IBI318 in the treatment of patients with advanced malignancies. The primary objectives of the study are to evaluate the safety, tolerability, and initial efficacy of IBI318.

On April 23, 2019 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, reported that it will participate in the Bank of America Merrill Lynch Healthcare Conference at the Encore Hotel in Las Vegas, Nevada (Press release, Zimmer Holdings, APR 23, 2019, View Source [SID1234535335]). Daniel P. Florin, Executive Vice President and Chief Financial Officer and Cole Lannum, CFA, Senior Vice President of Investor Relations, will present for the company on Thursday, May 16, 2019 at 8:00 a.m. Pacific Time.

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A live webcast of the presentation can be accessed via Zimmer Biomet’s Investor Relations website at http://investor.zimmerbiomet.com. The webcast will be archived for replay following the conference.

On April 23, 2019 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2019 first quarter financial results on Tuesday, May 7, 2019, after the close of the financial markets (Press release, Jazz Pharmaceuticals, APR 23, 2019, View Source [SID1234535336]). Company management will host a live audio webcast immediately following the announcement at 4:30 p.m. EDT/9:30 p.m. IST to discuss first quarter 2019 financial results and provide a business and financial update.

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Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be archived on the website for at least one week.

Audio webcast/conference call:
U.S. Dial-In Number: +1 855 353 7924
International Dial-In Number: +1 503 343 6056
Passcode: 6667859

A replay of the conference call will be available through May 14, 2019 and accessible through one of the following telephone numbers, using the passcode below:

Replay U.S. Dial-In Number: +1 855 859 2056
Replay International Dial-In Number: +1 404 537 3406
Passcode: 6667859