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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 341 drug applications between 4 March 2026 and 10 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 30, covering 22 drug names.

2026/03/04 – 2026/03/10

Period
2026/03/04 to 2026/03/10, 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
341
Drugs with new generic filings (by drug name, de-duplicated)
22
Accepted this week, now under review
93

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

341filings, 30 of them generic

By application type

Application typeFilings
Supplement222
New drug60
Generic30
Import19
Unspecified6
Import re-registration4

By drug type

Drug typeFilings
Chemical drug164
TCM105
Therapeutic biologic64
Prophylactic biologic6
Biologic2

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

22 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Cetitizine Hydrochloride Oral Solution316
2Polyvinyl Alcohol Eye Drops2224
3Sacubitril Valsartan Sodium Tablets2170
4磷苯妥英钠注射用浓溶液 · No verified English name216
5Acetate And Glucose Electrolytes Injection214
6Gadoteridol Injection213
7Finerenone Tablets2169
8Acetylcysteine Injection1153
9Acetylcysteine Tablets118
10Sodium Lactate Ringer's Irrigation Solution115

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

181 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hong Ji Tang Pharmaceutical (Lai Wu Qu) Co., Ltd. romanized17140
2Bayer Vital GmbH1610
3Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized1210
4Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized920
5Eli Lilly and Company730
6Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized640
7Janssen Research & Development LLC630
8Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized550
9Shanxi Huang He Zhong Yao Co., Ltd. romanized550
10Qilu Pharmaceutical Co., Ltd.540

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

92 this week

AcceptedDrugApplicants
2026/03/10Import · Class 1 JNJ-87189401 注射液 (皮下注射) · No verified English nameJXSL2600075 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/03/10Import · Class 1 JNJ-87189401 注射液 (皮下注射) · No verified English nameJXSL2600074 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/03/10Generic · Class 3 Sodium Lactate Ringer's Irrigation SolutionCYHS2600637 Shandong Hua Mao Pharma Co., Ltd. romanized
2026/03/10Generic · Class 3 Dexketoprofen Trometamol InjectionCYHL2600033 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2026/03/10New drug · Class 1.2 绣球总苷片 · No verified English nameCXZL2600028 Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized; Zhongguo Yi Xue Ke College Drug Research Institute romanized
2026/03/10New drug · Class 1.2 绣球总苷提取物 · No verified English nameCXZL2600027 Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized; Zhongguo Yi Xue Ke College Drug Research Institute romanized
2026/03/10New drug · Class 2.1 特瑞普利单抗注射液(皮下注射) · No verified English nameCXSS2600047 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2026/03/10New drug · Class 2.1 特瑞普利单抗注射液(皮下注射) · No verified English nameCXSS2600046 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2026/03/10New drug · Class 2.1 特瑞普利单抗注射液(皮下注射) · No verified English nameCXSS2600045 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2026/03/10New drug · Class 2.1 特瑞普利单抗注射液(皮下注射) · No verified English nameCXSS2600044 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2026/03/10New drug · Class 2.1 特瑞普利单抗注射液(皮下注射) · No verified English nameCXSS2600043 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2026/03/10New drug · Class 2.1 特瑞普利单抗注射液(皮下注射) · No verified English nameCXSS2600042 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2026/03/10New drug · Class 2.1 特瑞普利单抗注射液(皮下注射) · No verified English nameCXSS2600041 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2026/03/10New drug · Class 2.1 特瑞普利单抗注射液(皮下注射) · No verified English nameCXSS2600040 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai Jun Shi Bio Gong Cheng Co., Ltd. romanized
2026/03/10New drug · Class 1 鲁塞奇塔单抗注射液 · No verified English nameCXSS2600039 Jiangsu Sai Fu Shi Bio Technology Co., Ltd. romanized
2026/03/10New drug · Class 1 CLIO-8221 · No verified English nameCXSL2600316 Nuo Wei Tai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/03/10New drug · Class 2.3 培哚普利左氨氯地平片 · No verified English nameCXHL2600284 Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2026/03/10New drug · Class 2.2 HW-0001颗粒 · No verified English nameCXHL2600283 Anhui Yi Ke University Di Er Fu Shu Hospital romanized; Beijing Rui Yue Biopharmaceuticals Technology Co., Ltd. romanized
2026/03/10New drug · Class 2.2 HW-0001颗粒 · No verified English nameCXHL2600282 Anhui Yi Ke University Di Er Fu Shu Hospital romanized; Beijing Rui Yue Biopharmaceuticals Technology Co., Ltd. romanized
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

62 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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