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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 347 drug applications between 5 April 2026 and 11 April 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 51 drug names.

2026/04/05 – 2026/04/11

Period
2026/04/05 to 2026/04/11, 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
347
Drugs with new generic filings (by drug name, de-duplicated)
51
Accepted this week, now under review
104

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

347filings, 68 of them generic

By application type

Application typeFilings
Supplement186
Generic68
New drug52
Import25
Import re-registration10
Unspecified6

By drug type

Drug typeFilings
Chemical drug186
TCM97
Therapeutic biologic57
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

51 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ibuprofen Suspension3214
2Diclofenac Diethylamine Emulgel3120
3Topiramate Extended-release Capsules310
4Edaravone and Dexborneol Concentrated Solution for Injection2234
5Bromhexine Hydrochloride Solution For Inhalation211
6Vonoprazan Fumarate Tablets2160
7Levetiracetam in Sodium Chloride Injection212
8Erythromycin Lactobionate for Injection2113
9Dexmethylphenidate Hydrochloride Exended-release Capsules212
10Ambroxol Hydrochloride Oral Solution2146

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

193 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hebei Wan Sui Pharma Co., Ltd. romanized11100
2Novo Nordisk A/S1030
3Ha Yao Group Bio Gong Cheng Co., Ltd. romanized860
4Merck Sharp & Dohme B.V.620
5Li Lai Suzhou Pharmaceutical Co., Ltd. romanized620
6Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized610
7Jiangxi Ke Rui Pharma Co., Ltd. romanized530
8Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized520
9Boehringer Ingelheim International GmbH510
10Guangxi Yu Lin Pharmaceutical Group Co., Ltd. romanized440

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

100 this week

AcceptedDrugApplicants
2026/04/11Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600097 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/04/11Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600096 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/04/11Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600095 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/04/11Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600094 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/04/11Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600093 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/04/11Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600092 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/04/11Generic · Class 3 艾地骨化醇片 · No verified English nameCYHS2600842 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2026/04/11Generic · Class 3 艾地骨化醇片 · No verified English nameCYHS2600841 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2026/04/11Generic · Class 3 Acetylcysteine GranulesCYHS2600840 Chongqing Ke Rui Pharmaceutical (Group) Co., Ltd. romanized
2026/04/11Generic · Class 3 Diphenhydramine Hydrochloride InjectionCYHS2600837 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2026/04/11Generic · Class 3 Diphenhydramine Hydrochloride InjectionCYHS2600836 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2026/04/11Generic · Class 3 Levetiracetam in Sodium Chloride InjectionCYHS2600834 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2026/04/11Generic · Class 3 Levetiracetam in Sodium Chloride InjectionCYHS2600833 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2026/04/11Generic · Class 3 东莨菪碱透皮贴片 · No verified English nameCYHL2600045 Ya Bao Pharma Group Co., Ltd. romanized
2026/04/11New drug · Class 1 HLX3902注射液 · No verified English nameCXSL2600400 Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2026/04/11New drug · Class 1 注射用LY4175408 · No verified English nameCXSL2600399 Li Lai Suzhou Pharmaceutical Co., Ltd. romanized
2026/04/11New drug · Class 2.2 注射用SIM0692 · No verified English nameCXSL2600398 Shandong Xian Sheng Zai Ming Biopharmaceutical Co., Ltd. romanized
2026/04/11New drug · Class 1 注射用KR25102 · No verified English nameCXHL2600430 Jiangxi Ke Rui Pharma Co., Ltd. romanized
2026/04/10Import · Class 3.1 奥妥珠单抗注射液 · No verified English nameJXSS2600034 Roche Pharma (Schweiz) AG; Roche Diagnostics GmbH; Roche (China) Holding Ltd.
2026/04/10Import · Class 2.3 古塞奇尤单抗/戈利木单抗(JNJ-78934804)注射液 · No verified English nameJXSL2600098 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/04/10Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2600830 Henan Pu Rui Pharma Co., Ltd. romanized
2026/04/10Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2600829 Guizhou Qian Yao Group Pharmaceutical Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2026/04/10Generic · Class 3 Bromhexine Hydrochloride Solution For InhalationCYHL2600044 Shandong Hui Cheng Pharma Co., Ltd. romanized
2026/04/10Generic · Class 3 Bromhexine Hydrochloride Solution For InhalationCYHL2600043 Shandong Hui Cheng Pharma Co., Ltd. romanized
2026/04/10New drug · Class 1 SGT003注射液 · No verified English nameCXSL2600397 Beijing Shun Jing Biopharmaceuticals Technology Co., Ltd. romanized
2026/04/10New drug · Class 1 YB1-X7注射液(静脉输注) · No verified English nameCXSL2600396 Shao Xing Shan Wei Te Bio Technology Co., Ltd. romanized
2026/04/10New drug · Class 2.2 依苏帕格鲁肽α注射液 · No verified English nameCXSL2600395 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized
2026/04/10New drug · Class 2.2 依苏帕格鲁肽α注射液 · No verified English nameCXSL2600394 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized
2026/04/10New drug · Class 2.2 依苏帕格鲁肽α注射液 · No verified English nameCXSL2600393 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized
2026/04/10New drug · Class 2.2 依苏帕格鲁肽α注射液 · No verified English nameCXSL2600392 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized

70 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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