YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 485 drug applications between 5 July 2026 and 11 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 56 drug names.

2026/07/05 – 2026/07/11

Period
2026/07/05 to 2026/07/11, 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
485
Drugs with new generic filings (by drug name, de-duplicated)
56
Accepted this week, now under review
142

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

485filings, 73 of them generic

By application type

Application typeFilings
Supplement285
New drug80
Generic73
Import22
Unspecified15
Import re-registration10

By drug type

Drug typeFilings
Chemical drug229
TCM168
Therapeutic biologic76
Biologic6
Prophylactic biologic6

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

56 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

292 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized990
2Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized980
3Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized810
4Novo Nordisk A/S720
5Shanxi Ao Er Pharma Co., Ltd. romanized660
6Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized650
7Liquidia Technologies Inc.610
8Hubei Tai Zi Pharma Co., Ltd. romanized550
9Gui Lin San Jin Pharma Co., Ltd. romanized540
10Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized520

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

136 this week

AcceptedDrugApplicants
2026/07/10Import · Class 1 注射用BMS-986517 · No verified English nameJXSL2600156 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/07/10Import · Class 2.4 AZD9833片 · No verified English nameJXHL2600268 AstraZeneca AB; AstraZeneca Investment (China) Co. Limited
2026/07/10Generic · Class 3 Cetylpyridinium Chloride Buccal TabletsCYHS2601658 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2026/07/10Generic · Class 3 盐酸利多卡因胶浆 · No verified English nameCYHS2601657 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2026/07/10Generic · Class 3 Galanthamine Hydrobromide Oral SolutionCYHS2601656 Da Lian Bai Li Tian Hua Pharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2026/07/10Generic · Class 3 盐酸苯达莫司汀注射用浓溶液 · No verified English nameCYHS2601654 Hebei Tian Cheng Pharma Co., Ltd. romanized; Hebei Dao En Pharma Co., Ltd. romanized
2026/07/10Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2601653 Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized
2026/07/10Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2601652 Chongqing Shi Yi Li Pharmaceuticals Technology Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized
2026/07/10Generic · Class 3 Metronidazole SuppositoriesCYHL2600078 Haerbin Tian Mei Pharma Co., Ltd. romanized
2026/07/10New drug · Class 1.4 二价肠道病毒灭活疫苗(Vero细胞) · No verified English nameCXSS2600104 Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized
2026/07/10New drug · Class 1 注射用VBC108 · No verified English nameCXSL2600730 Shanghai Cheng Fan Pharmaceuticals Co., Ltd. romanized
2026/07/10New drug · Class 1 RG002注射液 · No verified English nameCXSL2600729 Ren Jing (Suzhou) Bio Technology Co., Ltd. romanized
2026/07/10New drug · Class 1 TQF6422 注射液 · No verified English nameCXSL2600728 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2026/07/10New drug · Class 2.2 特瑞普利单抗注射液 · No verified English nameCXSL2600727 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/10New drug · Class 1 Pumitamig注射液 · No verified English nameCXSL2600726 Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/07/10New drug · Class 1 SQ-25012注射液 · No verified English nameCXSL2600725 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2026/07/10New drug · Class 1 WGc-043注射液 · No verified English nameCXSL2600724 Chengdu Wei Si Jin Biopharmaceuticals Technology Co., Ltd. romanized
2026/07/10New drug · Class 2.2 玛硒洛沙韦干混悬剂 · No verified English nameCXHS2600101 Zheng Xiang Pharmaceuticals (Nanjing) Group Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized
2026/07/10New drug · Class 1 TQB3454片 · No verified English nameCXHS2600100 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2026/07/10New drug · Class 1 CC10166片 · No verified English nameCXHL2600836 Beijing Chen Yan Qi Yao Bio Technology Co., Ltd. romanized
2026/07/10New drug · Class 1 CC10166片 · No verified English nameCXHL2600835 Beijing Chen Yan Qi Yao Bio Technology Co., Ltd. romanized
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

106 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.