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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 337 drug applications between 3 March 2026 and 9 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 23, covering 17 drug names.

2026/03/03 – 2026/03/09

Period
2026/03/03 to 2026/03/09, 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
337
Drugs with new generic filings (by drug name, de-duplicated)
17
Accepted this week, now under review
75

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

337filings, 23 of them generic

By application type

Application typeFilings
Supplement224
New drug56
Generic23
Import23
Import re-registration7
Unspecified4

By drug type

Drug typeFilings
Chemical drug152
TCM110
Therapeutic biologic68
Prophylactic biologic6
Biologic1

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

17 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Cetitizine Hydrochloride Oral Solution316
2磷苯妥英钠注射用浓溶液 · No verified English name216
3Acetate And Glucose Electrolytes Injection214
4Gadoteridol Injection213
5Finerenone Tablets2169
6Acetylcysteine Injection1153
7Acetylcysteine Tablets118
8二甲双胍恩格列净片(I) · No verified English name112
9二甲双胍恩格列净片(VI) · No verified English name112
10二甲双胍恩格列净片(V) · No verified English name111

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

178 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hong Ji Tang Pharmaceutical (Lai Wu Qu) Co., Ltd. romanized17140
2Bayer Vital GmbH1610
3Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized920
4Eli Lilly and Company840
5Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized660
6Tianjin Hong Ren Tang Pharma Co., Ltd. romanized660
7Amgen Inc.610
8Shanxi Huang He Zhong Yao Co., Ltd. romanized550
9Shaanxi Pan Long Pharma Group Co., Ltd. romanized550
10Novo Nordisk A/S510

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

90 this week

AcceptedDrugApplicants
2026/03/09Generic · Class 3 Gemcitabine Hydrochloride InjectionCYHS2600632 Hefei Li Cheng Pharma Co., Ltd. romanized
2026/03/09New drug · Class 2.1 特瑞普利单抗注射液(皮下注射) · No verified English nameCXSS2600038 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2026/03/09New drug · Class 2.1 特瑞普利单抗注射液(皮下注射) · No verified English nameCXSS2600037 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2026/03/09New drug · Class 2.1 特瑞普利单抗注射液(皮下注射) · No verified English nameCXSS2600036 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2026/03/09New drug · Class 2.1 特瑞普利单抗注射液(皮下注射) · No verified English nameCXSS2600035 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2026/03/09New drug · Class 1 熊去氧胆小檗碱胶囊 · No verified English nameCXHS2600040 Shenzhen Jun Sheng Tai Bio Technology Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2026/03/07Generic · Class 3 磷苯妥英钠注射用浓溶液 · No verified English nameCYHS2600629 Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized
2026/03/07Generic · Class 3 磷苯妥英钠注射用浓溶液 · No verified English nameCYHS2600628 Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized
2026/03/07New drug · Class 2.2 冻干口服轮状减毒活疫苗(Vero细胞) · No verified English nameCXSL2600315 Chengdu Mai Ke Kang Bio Technology Co., Ltd. romanized; Chengdu Hua Ren Kang Bio Technology Co., Ltd. romanized; Shanghai Mai Ke Kang Bio Technology Co., Ltd. romanized
2026/03/07New drug · Class 1 注射用MK-1045 · No verified English nameCXSL2600314 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2026/03/07New drug · Class 1 GR1803注射液(皮下注射) · No verified English nameCXSL2600313 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2026/03/07New drug · Class 1 注射用MK-1045 · No verified English nameCXSL2600312 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2026/03/07New drug · Class 1.2 重组呼吸道合胞病毒疫苗(CHO细胞) · No verified English nameCXSL2600311 Yi Kang Bio (Suzhou) Co., Ltd. romanized
2026/03/07New drug · Class 1 RLX-2505注射液 · No verified English nameCXSL2600310 Suzhou Tuo Jie Pharmaceuticals Co., Ltd. romanized
2026/03/07New drug · Class 1.2 重组呼吸道合胞病毒疫苗(CHO细胞)(佐剂) · No verified English nameCXSL2600309 Yi Kang Bio (Suzhou) Co., Ltd. romanized
2026/03/07New drug · Class 1 SYH2095片 · No verified English nameCXHL2600281 Hangzhou Ying Chuang Pharmaceuticals Technology Co., Ltd. romanized; Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2026/03/07New drug · Class 1 SYH2095片 · No verified English nameCXHL2600280 Hangzhou Ying Chuang Pharmaceuticals Technology Co., Ltd. romanized; Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2026/03/07New drug · Class 1 HS-10541片 · No verified English nameCXHL2600279 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/03/07New drug · Class 1 HS-10541片 · No verified English nameCXHL2600278 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/03/07New drug · Class 2.2 BCM993 · No verified English nameCXHL2600277 Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized
2026/03/07New drug · Class 1 D3S-003片 · No verified English nameCXHL2600276 Name not romanized
2026/03/06Import · Class 2.2 帕博利珠单抗注射液 · No verified English nameJXSS2600020 MSD International Business GmbH; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd
2026/03/06Import · Class 2.4 贝组替凡片 · No verified English nameJXHS2600030 MERCK SHARP & DOHME (UK) LIMITED; MSD INTERNATIONAL GMBH; MSD R&D (China) Co. Ltd
2026/03/06Generic · Class 3 Acetylcysteine TabletsCYHS2600621 Hebei Rui Sen Pharma Co., Ltd. romanized
2026/03/06Generic · Class 3 Cetitizine Hydrochloride Oral SolutionCYHS2600618 Beijing Han Mei Bio Technology Co., Ltd. romanized; Beijing Han Mei Medicines Co., Ltd. romanized
2026/03/06Generic · Class 3 Cetitizine Hydrochloride Oral SolutionCYHS2600617 Beijing Han Mei Bio Technology Co., Ltd. romanized; Beijing Han Mei Medicines Co., Ltd. romanized
2026/03/06Generic · Class 3 Cetitizine Hydrochloride Oral SolutionCYHS2600616 Beijing Han Mei Bio Technology Co., Ltd. romanized; Beijing Han Mei Medicines Co., Ltd. romanized
2026/03/06Generic · Class 3 Acetate And Glucose Electrolytes InjectionCYHS2600615 Chengdu Sai Nuo Lian Chuang Bio Technology Co., Ltd. romanized; Sichuan Tai Ping Yang Pharma Co., Ltd. romanized
2026/03/06Generic · Class 3 Acetate And Glucose Electrolytes InjectionCYHS2600614 Chengdu Sai Nuo Lian Chuang Bio Technology Co., Ltd. romanized; Sichuan Tai Ping Yang Pharma Co., Ltd. romanized
2026/03/06New drug · Class 1.1 小儿健脾消食颗粒 · No verified English nameCXZL2600026 Shandong Han Fang Pharmaceutical Co., Ltd. romanized

60 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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