YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 520 drug applications between 3 July 2026 and 9 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 57 drug names.

2026/07/03 – 2026/07/09

Period
2026/07/03 to 2026/07/09, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
520
Drugs with new generic filings (by drug name, de-duplicated)
57
Accepted this week, now under review
130

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

520filings, 77 of them generic

By application type

Application typeFilings
Supplement301
New drug81
Generic77
Import38
Unspecified13
Import re-registration10

By drug type

Drug typeFilings
Chemical drug246
TCM195
Therapeutic biologic72
Biologic4
Prophylactic biologic3

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

57 drugs with new generic filings; top 10 listed

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

283 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized18160
2AstraZeneca AB1320
3Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized980
4Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized810
5Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized760
6Novo Nordisk A/S720
7Zhong Shan Shi Heng Sheng Pharma Co., Ltd. romanized660
8Kang Nuo Ya Biopharmaceuticals Technology Co., Ltd. romanized640
9Liquidia Technologies Inc.610
10Hubei Tai Zi Pharma Co., Ltd. romanized550

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

153 this week

AcceptedDrugApplicants
2026/07/09Import · Class 3.1 纳武利尤单抗注射液 · No verified English nameJXSS2600061 Bristol-Myers Squibb Pharma EEIG; Vetter Pharma-Fertigung GmbH & Co. KG; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/07/09Import · Class 3.1 纳武利尤单抗注射液 · No verified English nameJXSS2600060 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/07/09Import · Class 3.1 纳武利尤单抗注射液 · No verified English nameJXSS2600059 Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/07/09Import · Class 1 恩利西肽片 · No verified English nameJXHS2600075 Merck Sharp & Dohme LLC; MSD INTERNATIONAL GMBH (SINGAPORE BRANCH); Name not romanized
2026/07/09Import · Class 1 BMS-986368胶囊 · No verified English nameJXHL2600267 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/07/09Import · Class 1 BMS-986368胶囊 · No verified English nameJXHL2600266 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/07/09Generic · Class 3 Ferrous Succinate TabletsCYHS2601649 Lin Fen Bao Zhu Pharmaceutical Co., Ltd. romanized
2026/07/09Generic · Class 3 Bilastine Oral SolutionCYHS2601648 Hefei Hua Wei Pharma Co., Ltd. romanized
2026/07/09Generic · Class 3 Tobramycin Sulfate InjectionCYHS2601644 Shu Mei Qi Chengdu Bio Technology Co., Ltd. romanized; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized
2026/07/09Generic · Class 3 艾地骨化醇片 · No verified English nameCYHS2601641 Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized
2026/07/09Generic · Class 3 多种微量元素注射液(Ι) · No verified English nameCYHS2601639 Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized
2026/07/09New drug · Class 1 注射用HS-20197 · No verified English nameCXSL2600723 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/07/09New drug · Class 1 IBR822细胞注射液 · No verified English nameCXSL2600722 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2026/07/09New drug · Class 1 IBR822细胞注射液 · No verified English nameCXSL2600721 Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized
2026/07/09New drug · Class 1 MSTA注射液 · No verified English nameCXSL2600720 Yin Nuo Wei (Beijing) Bio Medical Technology Co., Ltd. romanized
2026/07/09New drug · Class 1 MSTA注射液 · No verified English nameCXSL2600719 Yin Nuo Wei (Beijing) Bio Medical Technology Co., Ltd. romanized
2026/07/09New drug · Class 1 DBC-664注射液 · No verified English nameCXSL2600718 Shuo Lei Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2026/07/09New drug · Class 1 DBC-664注射液 · No verified English nameCXSL2600717 Shuo Lei Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2026/07/09New drug · Class 1 SAR448851 · No verified English nameCXHL2600834 Sai Nuo Fei (Zhongguo) Investment Co., Ltd. romanized
2026/07/09New drug · Class 1 SAR448851 · No verified English nameCXHL2600833 Sai Nuo Fei (Zhongguo) Investment Co., Ltd. romanized
2026/07/09New drug · Class 1 ANS05片 · No verified English nameCXHL2600832 Beijing An Shi Bio Technology Co., Ltd. romanized
2026/07/09New drug · Class 1 ANS05片 · No verified English nameCXHL2600831 Beijing An Shi Bio Technology Co., Ltd. romanized
2026/07/09New drug · Class 1 BPR-30901649注射液 · No verified English nameCXHL2600830 Chengdu Bei Te Rui Ma Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/08Import · Class 1 Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600155 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd
2026/07/08Import · Class 1 Telisotuzumab Adizutecan 注射用粉末 · No verified English nameJXSL2600154 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd
2026/07/08Import · Class 1 DS-1103a · No verified English nameJXSL2600153 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2026/07/08Import · Class 1 DS-3939a · No verified English nameJXSL2600152 Daiichi Sankyo Inc.; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2026/07/08Import · Class 2.2 L606 (曲前列尼尔脂质体吸入混悬液) · No verified English nameJXHL2600265 Liquidia Technologies Inc.; Shanghai Harvest Medical Technology Co. Ltd.
2026/07/08Import · Class 2.2 L606 (曲前列尼尔脂质体吸入混悬液) · No verified English nameJXHL2600264 Liquidia Technologies Inc.; Shanghai Harvest Medical Technology Co. Ltd.
2026/07/08Import · Class 2.2 L606 (曲前列尼尔脂质体吸入混悬液) · No verified English nameJXHL2600263 Liquidia Technologies Inc.; Shanghai Harvest Medical Technology Co. Ltd.

123 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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