CP Tianqing’s blockbuster innovative drug Anlotinib Hydrochloride Capsules Approved for Marketing

On May 9, 2018 Chia Tai Tianqing Pharmaceutical Group reported the 1.1-type new drug Anlotinib Hydrochloride Capsules (Focavi) obtained the registration approval document approved by the State Drug Administration (Press release, Jiangsu Chia-tai Tianqing, MAY 9, 2018, View Source [SID1234576212]). This marks the official launch of Anlotinib, an original and innovative drug in the Chinese oncology field that has received much attention. Wang Shanchun, president of CP Tianqing Pharmaceutical Group, said: "We expect that this new national drug will benefit more Chinese patients and even patients around the world after it is launched."

Anlotinib refers to advanced non-small cell lung cancer

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

After more than 10 years of hard work, the R&D team of CP Tianqing finally made a breakthrough in the development of oncology drugs. The 1.1-type new drug Anlotinib Hydrochloride Capsules was approved for marketing. This product is a new type of small molecule multi-target tyrosine kinase inhibitor, which can effectively inhibit VEGFR, PDGFR, FGFR, c-Kit and other kinases, and has the dual effects of anti-tumor angiogenesis and inhibiting tumor growth. Clinical trials have confirmed that Focavi is the only effective single-drug oral preparation among the anti-angiogenesis targeted drugs for advanced non-small cell lung cancer, and its adverse reactions are relatively mild, and it is well tolerated by patients. According to analysis by industry experts, Anlotinib is expected to become the standard drug for the third-line treatment of patients with advanced non-small cell lung cancer.

"The listing of Anlotinib is also due to the ongoing reform measures for drug review and approval by the State Food and Drug Administration. As clinical studies have shown that Anlotinib has obvious clinical advantages over existing treatments, after the application That is, it was included in the priority review sequence by the drug review center. It is precisely because of the attention of the drug review department and the review experts working overtime that Anlotinib completed the marketing review and was approved in a short period of time. This will enable the majority of patients to use safe and effective anti-tumor innovative drugs as soon as possible." Wang Shanchun believes that the drug review period coincides with the national drug review and approval policy reform period, and the country’s orientation to encourage R&D and innovation is becoming more and more obvious. The approval of innovative drugs with outstanding clinical value such as Anlotinib has been guaranteed and encouraged. Through the priority review procedure, the Center for Drug Evaluation has provided an effective guarantee for meeting clinical drug needs, reducing drug costs, and promoting public health.

The clinical research results show that Focavi not only has a good therapeutic effect on non-small cell lung cancer, but also on soft tissue sarcoma, ovarian cancer and other cancers. CT Tianqing is actively carrying out multi-center clinical research including the United States. . The results of the Phase 2b clinical study of Anlotinib in the treatment of soft tissue sarcoma were reported orally by ASCO (Free ASCO Whitepaper) this year, and the results of the pathological subgroup of the Phase 3 clinical study for the treatment of non-small cell lung cancer were displayed in the ASCO (Free ASCO Whitepaper) this year, and were written into the "2018 CSCO Lung Cancer Guidelines" . Wang Shanchun said: "It is not easy for China’s original innovative drugs to have won such an honor before they went on the market. This shows the international recognition of Chinese innovative drugs."

Malignant tumors are the unbearable weight of life

There are more than 4 million new cancer patients in China each year, and an average of more than 10,000 people are diagnosed as new patients every day, and the incidence rate is increasing year by year. In particular, lung cancer ranks first in morbidity and mortality among men, and second in morbidity and mortality among women. The five-year survival period of cancer patients is much lower than the average in developed countries.

As an ordinary citizen, once diagnosed with a malignant tumor disease, not only the patient himself will suffer both physical and mental torture, loss of hope of survival, loss of dignity of life, but also a family may be crushed by this, and bear a heavy burden from then on The unbearable spiritual and economic burden. As an enterprise with a social conscience, CP Tianqing is also working hard, hoping to one day conquer the persistent disease of malignant tumors through technological innovation.

In recent years, with the development of traditional chemotherapy, targeted therapy and immunotherapy have successively entered first-line and second-line treatment, and the treatment of advanced non-small cell lung cancer has been greatly improved. However, for Chinese patients who have failed first-line and second-line treatments, the existing third-line treatments are relatively lacking and the choices are confusing, and patients are often in the predicament of no medicines available. In this case, the new small molecule multi-target tyrosine kinase inhibitor anlotinib independently developed by CT Tianqing has finally succeeded, providing an effective new method for the third-line treatment of patients with advanced non-small cell lung cancer in China. treatment method.

CP Tianqing has a rich product line in the anti-tumor field

The listing of Anlotinib can be said to be a milestone event in the development history of CP Tianqing. The drug is Chia Tai Tianqing’s first innovative small molecule drug in accordance with international R&D procedures and standards, and it is also the company’s most invested anti-cancer drug so far. The successful listing of Anlotinib marks a solid step forward by CP Tianqing from "combination of imitation and innovation" to "combination of innovation and imitation". It is also a major breakthrough in the oncology field of the company based on the "focus on liver disease" strategy. .

Chia Tai Tianqing Pharmaceutical Group is an innovative pharmaceutical group enterprise integrating scientific research, production and sales. It is a well-known liver health drug research and development and production base in China. It is a national key high-tech enterprise and a national Torch Plan Lianyungang new pharmaceutical industry base. The backbone enterprise ranks 16th among the top 100 enterprises in China’s pharmaceutical industry. Chia Tai Tianqing currently invests more than 10% of its sales revenue every year. It has more than 1,000 R&D personnel and more than 180 products under research, including more than 40 innovative drugs and more than 20 biological drugs.

It is reported that in addition to the field of strong liver diseases, CP Tianqing has also formed a unique product line in the field of anti-tumor. Hematological tumor products Decitabine, Imatinib, and Dasatinib are the first imitation products in China. In the next three years, CP Tianqing will launch more products in the oncology field, such as bortezomib, bendamustine, lenalidomide, azacitidine, etc., to improve drug accessibility and quality of life for cancer patients.

Atara Biotherapeutics Expands T-Cell Immunotherapy Collaboration to Advance Next-Generation CAR T Technologies in Oncology, Autoimmune and Other Diseases

On May 8, 2018 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported the Company has expanded its collaboration with Memorial Sloan Kettering Cancer Center (MSK) to develop the next generation of genetically engineered chimeric antigen receptor T-cell (CAR T) immunotherapies (Press release, Atara Biotherapeutics, MAY 8, 2018, View Source [SID1234526196]). This agreement is the next step in Atara’s strategy to leverage the potential of the Company’s technology platform to develop genetically modified off-the-shelf, allogeneic T-cell immunotherapies to transform the lives of patients with serious medical conditions.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the agreement, Atara will gain access to several of MSK’s innovative enabling technologies, including a novel CAR T construct that Atara believes has physiologic T-cell activation properties, as well as methods for designing CAR T immunotherapies. Atara is also entering into an exclusive research collaboration for multiple targets with Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering at MSK, to employ next-generation technologies in developing novel CAR T immunotherapies with applications in oncology, autoimmune and infectious diseases.

Dr. Sadelain stated, "We are eager to work with Atara to continue advancing promising allogeneic T-cell immunotherapy technologies that originated at MSK. The new CAR T technologies seek to overcome persistent therapeutic challenges, such as safety and tolerability, durability of treatment response, and activity in areas of significant unmet medical need that are underserved by the current generation of CAR T immunotherapies."

"Our earlier MSK collaboration has been highly productive, highlighted by tab-cel, Atara’s off-the-shelf, allogeneic T-cell immunotherapy currently in Phase 3 development," said Isaac Ciechanover, M.D., Chief Executive Officer and President of Atara Biotherapeutics. "The deepening of our collaboration with MSK allows us to rapidly advance novel gene-edited CAR T development programs leveraging our existing off-the-shelf T-cell immunotherapy technology platform, manufacturing expertise and research and development capabilities. Going forward, we plan to continue to assemble complementary genetic engineering technologies to grow our pipeline and realize the full potential of our platform."

MediciNova to Present at the UBS Global Healthcare Conference in New York

On May 8, 2018 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), reported that MediciNova will present a corporate overview at the UBS Global Healthcare Conference on Monday, May 21, 2018 at 9:00 am at the Grand Hyatt New York in New York City (Press release, MediciNova, MAY 8, 2018, View Source;p=RssLanding&cat=news&id=2347957 [SID1234526227]). Yuichi Iwaki, MD, PhD, President and Chief Executive Officer, and Geoffrey O’Brien, JD/MBA, Vice President and Executive Officer, will be available for one-on-one meetings at this conference and investors may request a one-on-one meeting through UBS.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

OncoMed Announces First Quarter 2018 Financial Results and Operational Highlights

On May 8, 2018 OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported first quarter 2018 financial results and provided a corporate update (Press release, OncoMed, MAY 8, 2018, View Source [SID1234526243]). As of March 31, 2018, cash, cash equivalents, and short-term investments totaled $88.4 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The Company is encouraged by ongoing clinical progress on its two most advanced immuno-oncology programs, anti-TIGIT and GITRL-Fc, and preclinical data on these programs were recently highlighted in multiple poster presentations at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. We also continue to dose patients in two Phase 1b studies of navicixizumab, our anti-DLL4/VEGF bispecific antibody. We look forward to delivering on numerous near-term catalysts, including the initiation of the Phase 1b portion of the anti-TIGIT study in combination with anti-PD1 in the second quarter of this year, the publication of the navicixizumab Phase 1a manuscript and the presentation of the navicixizumab Phase 1b ovarian cancer data in the second half of 2018, and the planned presentation of the anti-TIGIT Phase 1a data in the fourth quarter of 2018," stated John Lewicki, Ph.D., President and CEO of OncoMed.

Pipeline Highlights

Anti-TIGIT (OMP-313M32)

OncoMed plans to initiate dosing of the Phase 1b portion of its Phase 1a/b anti-TIGIT (OMP-313M32) trial, in combination with anti-PD1, in the second quarter of 2018. The Phase 1b portion of the open-label clinical trial is designed to assess the safety, tolerability, preliminary efficacy, and pharmacodynamic biomarkers of escalating doses of OMP-313M32 in combination with anti-PD1 for the treatment of patients with solid tumors who have progressed after prior treatment with anti-PD1 or anti-PD-L1.
OncoMed continues enrollment in the Phase 1a single-agent study of anti-TIGIT in patients with advanced or metastatic solid tumors. The Phase 1a study is designed to assess safety and tolerability of escalating doses of anti-TIGIT. Biomarkers will be assessed in this study which includes a single-agent dose expansion cohort.
The company currently expects to present data from the Phase 1a portion of the Phase 1a/b study in the fourth quarter of 2018.
Navicixizumab (anti-DLL4/VEGF bispecific; OMP-305B83)

Enrollment continues in two Phase 1b multi-center, open-label, dose escalation and expansion studies of OncoMed’s anti-DLL4/VEGF bispecific antibody in combination with standard-of-care chemotherapies: one in patients with platinum-resistant ovarian cancer who have failed more than two prior therapies or prior bevacizumab and a second in patients with 2nd line metastatic colorectal cancer.
To date, OncoMed has enrolled approximately 100 patients across the Phase 1a and Phase 1b trials of navicixizumab.
The Phase 1a data are expected to be published in the second half of 2018, and interim data from the ongoing Phase 1b ovarian cancer study are also expected to be reported in the second half of 2018.
GITRL-Fc (OMP-336B11)

Robust enrollment continues in the Phase 1a single-agent study of its wholly-owned GITRL-Fc in patients with advanced or metastatic solid tumors. GITRL-Fc is a fusion protein with an Fc-linked fully human trimer ligand and is designed to activate the co-stimulatory receptor GITR (glucocorticoid-induced tumor necrosis factor receptor-related protein) to enhance T-cell modulated immune responses. The Phase 1a study is designed to assess safety and tolerability of escalating doses.
The Phase 1a data are expected to be presented in 2019.
New product discovery

OncoMed continues to make strong progress in its pursuit of novel immune-oncology agents, including emerging opportunities from the TNF superfamily of ligands, using the company’s proprietary linkerless fully human trimer technology.
First Quarter 2018 Financial Results

Cash, cash equivalents and short-term investments totaled $88.4 million as of March 31, 2018, compared to $103.1 million as of December 31, 2017.

Revenues were $7.8 million for the first quarter of 2018, an increase of $1.6 million, compared to $6.2 million for the same period in 2017. The change in revenue was due to the effect of the adoption of the new revenue recognition standard in the first quarter of 2018. For further discussion regarding our adoption of the new revenue recognition standard and its effects, see page 12 of our Quarterly Report on Form 10-Q for the first quarter ended March 31, 2018, filed with the Securities and Exchange Commission on May 8, 2018.

Research and development (R&D) expenses were $8.4 million for the first quarter of 2018, a decrease of $15.6 million, compared to $24.0 million for the same period in 2017. The decrease in R&D expenses was due to decreases in clinical development costs and reduced headcount following the restructuring actions in April 2017.

General and administrative (G&A) expenses were $5.4 million for the first quarter of 2018, an increase of $0.4 million, compared to $5.0 million for the same period in 2017. The increase in G&A expenses was primarily due to an increase in personnel cost, including retention bonus and severance expenses in the first quarter of 2018, offset by a decrease in headcount as a result of restructuring actions in April 2017.

Net loss for the first quarter of 2018 was $5.6 million ($0.15 per share), compared to $22.6 million ($0.61 per share) for the same period of 2017. The change in year-over-year net loss was primarily due to lower operating expenses in the first quarter of 2018.

2018 Financial Guidance

OncoMed’s current cash is estimated to be sufficient to fund operations through at least the third quarter of 2019, without taking into account future potential milestone or opt-in payments from its partners. OncoMed estimates 2018 operating cash burn to be approximately $55 million, before considering potential milestone or opt-in payments.

Interim Report First Quarter 2018

On May 8, 2018 Interim Report for the First Quarter of 2018(Press release, Genmab, MAY 8, 2018, View Source [SID1234526260]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Highlights

USD 432 million in net sales of DARZALEX (daratumumab); resulting in royalty income of DKK 310 million

U.S. FDA granted Priority Review to daratumumab in combination with bortezomib, melphalan and prednisone in frontline multiple myeloma

Received USD 50 million from Novartis as payment for lost potential milestones and royalties following announcement of Novartis’ intention to transition Arzerra (ofatumumab) to limited availability via compassionate use programs for chronic lymphocytic leukemia (CLL) in non-US markets

"During the first quarter of 2018, we saw regulatory progress with DARZALEX in multiple myeloma, continued to progress our innovative pipeline, and experienced good progress in a number of antibody programs run by our collaboration partners. We look forward to an exciting year ahead," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Quarter of 2018

Revenue was DKK 681 million in the first quarter of 2018 compared to DKK 251 million in the first quarter of 2017. The increase of DKK 430 million, or 171%, was mainly driven by the payment from Novartis of USD 50 million and higher DARZALEX royalties.
Operating expenses were DKK 357 million in the first quarter of 2018 compared to DKK 205 million in the first quarter of 2017. The increase of DKK 152 million, or 74%, was driven by the advancement of tisotumab vedotin, additional investments in our product pipeline, and the increase in employees to support expansion of our product pipeline.
Operating income was DKK 324 million in the first quarter of 2018 compared to DKK 46 million in the first quarter of 2017. The increase of DKK 278 million was driven by higher revenue, which was partly offset by increased operating expenses.
Outlook
Genmab is maintaining its 2018 financial guidance published on February 21, 2018.

Conference Call
Genmab will hold a conference call in English to discuss the results for the first quarter of 2018 today, Tuesday, May 8, at 6.00 pm CEST, 5.00 pm BST or 12.00 pm EDT. The dial in numbers are:

+1 323 794 2094 (US participants) and ask for the Genmab conference call
+44 330 336 9411 (international participants) and ask for the Genmab conference call

A live and archived webcast of the call and relevant slides will be available at www.genmab.com.

Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: [email protected]

This interim report contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the section "Risk Management" in Genmab’s annual report, which is available on www.genmab.com and the "Significant Risks and Uncertainties" section in this interim report. Genmab does not undertake any obligation to update or revise forward looking statements in this interim report nor to confirm such statements in relation to actual results, unless required by law.

Genmab A/S and its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; the DuoBody logo; the HexaBody logo; HuMax; HuMax-CD20; DuoBody; HexaBody and UniBody. Arzerra is a trademark of Novartis AG or its affiliates. DARZALEX is a trademark of Janssen Biotech, Inc.

Download the full Interim Report for the first quarter of 2018 on attachment or at www.genmab.com.

CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Highlights

USD 432 million in net sales of DARZALEX (daratumumab); resulting in royalty income of DKK 310 million
U.S. FDA granted Priority Review to daratumumab in combination with bortezomib, melphalan and prednisone in frontline multiple myeloma
Received USD 50 million from Novartis as payment for lost potential milestones and royalties following announcement of Novartis’ intention to transition Arzerra (ofatumumab) to limited availability via compassionate use programs for chronic lymphocytic leukemia (CLL) in non-US markets
"During the first quarter of 2018, we saw regulatory progress with DARZALEX in multiple myeloma, continued to progress our innovative pipeline, and experienced good progress in a number of antibody programs run by our collaboration partners. We look forward to an exciting year ahead," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Quarter of 2018

Revenue was DKK 681 million in the first quarter of 2018 compared to DKK 251 million in the first quarter of 2017. The increase of DKK 430 million, or 171%, was mainly driven by the payment from Novartis of USD 50 million and higher DARZALEX royalties.
Operating expenses were DKK 357 million in the first quarter of 2018 compared to DKK 205 million in the first quarter of 2017. The increase of DKK 152 million, or 74%, was driven by the advancement of tisotumab vedotin, additional investments in our product pipeline, and the increase in employees to support expansion of our product pipeline.
Operating income was DKK 324 million in the first quarter of 2018 compared to DKK 46 million in the first quarter of 2017. The increase of DKK 278 million was driven by higher revenue, which was partly offset by increased operating expenses.
Outlook
Genmab is maintaining its 2018 financial guidance published on February 21, 2018.

Conference Call
Genmab will hold a conference call in English to discuss the results for the first quarter of 2018 today, Tuesday, May 8, at 6.00 pm CEST, 5.00 pm BST or 12.00 pm EDT. The dial in numbers are:

+1 323 794 2094 (US participants) and ask for the Genmab conference call
+44 330 336 9411 (international participants) and ask for the Genmab conference call

A live and archived webcast of the call and relevant slides will be available at www.genmab.com.

Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: [email protected]

This interim report contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the section "Risk Management" in Genmab’s annual report, which is available on www.genmab.com and the "Significant Risks and Uncertainties" section in this interim report. Genmab does not undertake any obligation to update or revise forward looking statements in this interim report nor to confirm such statements in relation to actual results, unless required by law.

Genmab A/S and its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; the DuoBody logo; the HexaBody logo; HuMax; HuMax-CD20; DuoBody; HexaBody and UniBody. Arzerra is a trademark of Novartis AG or its affiliates. DARZALEX is a trademark of Janssen Biotech, Inc.

Download the full Interim Report for the first quarter of 2018 on attachment or at www.genmab.com.

CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122