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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 476 drug applications between 13 August 2026 and 19 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 56 drug names.

2026/08/13 – 2026/08/19

Period
2026/08/13 to 2026/08/19, 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
476
Drugs with new generic filings (by drug name, de-duplicated)
56
Accepted this week, now under review
238

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

476filings, 74 of them generic

By application type

Application typeFilings
Supplement286
Generic74
New drug64
Import42
Import re-registration6
Unspecified4

By drug type

Drug typeFilings
Chemical drug229
TCM173
Therapeutic biologic66
Prophylactic biologic7
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

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

272 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanghai Min Wei Bio Technology Co., Ltd. romanized1410
2Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized1030
3Jilin Gao Miao Pharma Co., Ltd. romanized990
4Eli Lilly and Company820
5Novo Nordisk A/S820
6Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized771
7Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized760
8Yi Chang Ren Fu Pharma Co., Ltd. romanized733
9F. Hoffmann-La Roche Ltd720
10Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized720

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

122 this week

AcceptedDrugApplicants
2026/08/19Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600075 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2026/08/19Import · Class 3.1 帕博利珠单抗注射液(皮下注射) · No verified English nameJXSS2600074 Merck Sharp & Dohme B.V.; BSP Pharmaceuticals S.p.A.; MSD R&D (China) Co. Ltd
2026/08/19Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600216 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/08/19Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600215 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/08/19Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600214 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/08/19Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600213 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/08/19Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600212 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/08/19Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600211 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/08/19Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600210 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/08/19Import · Class 1 BMS-986368胶囊 · No verified English nameJXHL2600357 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/08/19Import · Class 1 BMS-986368胶囊 · No verified English nameJXHL2600356 Celgene Corporation; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/08/19Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2600355 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2026/08/19Import · Class 2.4 Osimertinib Mesylate TabletsJXHL2600354 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd
2026/08/19Generic · Class 3 Thioctic Acid TabletsCYHS2602051 Guangdong Jian Xin Pharmaceutical Co., Ltd. romanized
2026/08/19Generic · Class 3 Metronidazole SuppositoriesCYHL2600088 Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized
2026/08/19New drug · Class 2.2 四价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSS2600129 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized
2026/08/19New drug · Class 2.2 四价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSS2600128 Wuhan Bio Zhi Pin Research Institute Co., Ltd. romanized
2026/08/19New drug · Class 1 注射用LM-350 · No verified English nameCXSL2600880 Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/08/19New drug · Class 1 IBI343 · No verified English nameCXSL2600879 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/08/19New drug · Class 1 CPD705注射液 · No verified English nameCXHL2601021 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2026/08/19New drug · Class 1 CPD705注射液 · No verified English nameCXHL2601020 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2026/08/19New drug · Class 1 BW-41012注射液 · No verified English nameCXHL2601019 Shanghai Bo Wang Pharmaceutical Co., Ltd. romanized
2026/08/19New drug · Class 1 BW-41012注射液 · No verified English nameCXHL2601018 Shanghai Bo Wang Pharmaceutical Co., Ltd. romanized
2026/08/19New drug · Class 1 QLS1510片 · No verified English nameCXHL2601017 Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized
2026/08/19New drug · Class 1 QLS1510片 · No verified English nameCXHL2601016 Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized
2026/08/19New drug · Class 1 PSTA100胶囊 · No verified English nameCXHL2601015 Pu Luo Si Te (Nanjing) Bio Technology Co., Ltd. romanized
2026/08/19New drug · Class 1 PSTA100胶囊 · No verified English nameCXHL2601014 Pu Luo Si Te (Nanjing) Bio Technology Co., Ltd. romanized
2026/08/19New drug · Class 1 LY4064809片 · No verified English nameCXHL2601013 Li Lai Suzhou Pharmaceutical Co., Ltd. romanized
2026/08/19New drug · Class 1 LY4064809片 · No verified English nameCXHL2601012 Li Lai Suzhou Pharmaceutical Co., Ltd. romanized
2026/08/19New drug · Class 1 LY4064809片 · No verified English nameCXHL2601011 Li Lai Suzhou Pharmaceutical Co., Ltd. romanized

92 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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