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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 423 drug applications between 1 September 2026 and 7 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 53 drug names.

2026/09/01 – 2026/09/07

Period
2026/09/01 to 2026/09/07, 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
423
Drugs with new generic filings (by drug name, de-duplicated)
53
Accepted this week, now under review
334

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

423filings, 68 of them generic

By application type

Application typeFilings
Supplement230
New drug79
Generic68
Import32
Import re-registration10
Unspecified4

By drug type

Drug typeFilings
Chemical drug205
TCM139
Therapeutic biologic75
Prophylactic biologic4

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

53 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

257 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AbbVie Inc.810
2Gan Li Pharma Shandong Co., Ltd. romanized810
3AstraZeneca AB730
4Novartis Pharma AG640
5Beijing Kang Di Ni Pharma Co., Ltd. romanized550
6Qinghai Qi Ying Han Cang Biopharmaceutical Co., Ltd. romanized550
7Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized540
8Pfizer Inc.530
9Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized510
10Changchun Jin Sai Pharma Co., Ltd. romanized510

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

131 this week

AcceptedDrugApplicants
2026/09/07Import · Class 1 DKB903注射用浓溶液 · No verified English nameJXSL2600240 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/09/07Generic · Class 3 复方葡萄糖/电解质颅脑手术冲洗液 · No verified English nameCYHS2602231 Wu Hu Dao Run Pharma Co., Ltd. romanized
2026/09/07Generic · Class 3 Entecavir oral solutionCYHS2602228 Anhui Kang Rong Pharma Co., Ltd. romanized
2026/09/07Generic · Class 3 盐酸精氨酸注射液 · No verified English nameCYHS2602227 Jiangsu Chang Jiang Pharma Co., Ltd. romanized
2026/09/07Generic · Class 3 Pimavanserin Tartrate CapsulesCYHS2602224 Tianjin Tian Shi Li Sheng Te Pharmaceutical Co., Ltd. romanized
2026/09/07Generic · Class 3 Fexofenadine Hydrochloride TabletsCYHS2602222 Hefei He Yuan Pharma Co., Ltd. romanized
2026/09/07Generic · Class 3 Dexketoprofen Trometamol InjectionCYHS2602215 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2026/09/07Generic · Class 3 酒石酸匹莫范色林片 · No verified English nameCYHS2602212 Tianjin Tian Shi Li Sheng Te Pharmaceutical Co., Ltd. romanized
2026/09/07Generic · Class 3 黄体酮注射液(Ⅱ) · No verified English nameCYHS2602210 Wuhan Jiu Long Pharmaceuticals Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2026/09/07New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600147 Chongqing Chen An Biopharmaceutical Co., Ltd. romanized
2026/09/07New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600146 Chongqing Chen An Biopharmaceutical Co., Ltd. romanized
2026/09/07New drug · Class 1 JH035注射液 · No verified English nameCXSL2600966 Bai Tai Bio Pharma Co., Ltd. romanized; An Bo Tai Ke Pharma Co., Ltd. romanized
2026/09/07New drug · Class 2.2 吸附无细胞百(五组分)白破联合疫苗 · No verified English nameCXSL2600965 Kang Xi Nuo Bio Shareholding Company romanized
2026/09/07New drug · Class 2.2 恩朗苏拜单抗注射液 · No verified English nameCXSL2600964 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/09/07New drug · Class 1 SYS6085注射液 · No verified English nameCXSL2600963 Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized
2026/09/07New drug · Class 1 奥莱泊肽注射液 · No verified English nameCXHS2600126 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Name not romanized
2026/09/07New drug · Class 2.2 司美格鲁肽微针贴片 · No verified English nameCXHL2601084 Zhuhai Ke Rui Wei Pharmaceuticals Technology Co., Ltd. romanized
2026/09/07New drug · Class 2.2 司美格鲁肽微针贴片 · No verified English nameCXHL2601083 Zhuhai Ke Rui Wei Pharmaceuticals Technology Co., Ltd. romanized
2026/09/07New drug · Class 2.2 司美格鲁肽微针贴片 · No verified English nameCXHL2601082 Zhuhai Ke Rui Wei Pharmaceuticals Technology Co., Ltd. romanized
2026/09/07New drug · Class 1 HRS-4518舌下片 · No verified English nameCXHL2601081 Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/09/07New drug · Class 1 HRS-4518舌下片 · No verified English nameCXHL2601080 Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/09/04Import · Class 1 JNJ-79635322 · No verified English nameJXSL2600239 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/09/04Import · Class 1 JNJ-79635322 · No verified English nameJXSL2600238 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/09/04Import · Class 1 FUB523注射液 · No verified English nameJXSL2600237 Novartis Pharma AG
2026/09/04Import · Class 1 Giredestrant胶囊 · No verified English nameJXHL2600397 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/09/04Import · Class 2.4 Zavegepant鼻喷雾剂 · No verified English nameJXHL2600396 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/09/04Import · Class 1 MK-1084片 · No verified English nameJXHL2600395 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/09/04Import · Class 1 MK-1084片 · No verified English nameJXHL2600394 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/09/04Generic · Class 3 Simethicone Chewable TabletsCYHS2602208 Jilin Sheng Bo Cai Zhong Ke Biopharmaceuticals Co., Ltd. romanized; Jilin Sheng Bo Da Wei Ye Pharmaceutical Co., Ltd. romanized
2026/09/04Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2602206 Hebei Hua Chen Pharma Group Co., Ltd. romanized

101 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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