YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 283 drug applications between 2 May 2026 and 8 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 33, covering 26 drug names.

2026/05/02 – 2026/05/08

Period
2026/05/02 to 2026/05/08, 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
283
Drugs with new generic filings (by drug name, de-duplicated)
26
Accepted this week, now under review
68

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

283filings, 33 of them generic

By application type

Application typeFilings
Supplement169
New drug39
Generic33
Import30
Unspecified11
Import re-registration1

By drug type

Drug typeFilings
Chemical drug119
TCM115
Therapeutic biologic43
Biologic6

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

26 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Piracetam Injection219
2Dotinurad Tablets2155
3Nafamostat Mesilate for Injection2138
4Trazodone Hydrochloride Sustained-release Tablets2120
5Mirogabalin Besilate Tablets2161
6Dapagliflozin Tablets2184
7Atosiban Acetate Injection212
8Fluticasone Propionate Nebuliser Suspension118
9Pemafibrate Tablets1123
10噻托溴铵吸入粉雾剂 · No verified English name112

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

174 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB1610
2Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized1280
3Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized980
4Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized550
5Pfizer Inc.540
6Jilin Sheng Zhong Yan Pharma Co., Ltd. romanized540
7Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized430
8Hui Sheng Biopharmaceutical Co., Ltd. romanized420
9Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized410
10Zhejiang Dao Er Bio Technology Co., Ltd. romanized410

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

68 this week

AcceptedDrugApplicants
2026/05/08Import · Class 3.1 注射用Belantamab mafodotin · No verified English nameJXSL2600111 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Company Limited
2026/05/08Import · Class 2.2 注射用Belantamab mafodotin · No verified English nameJXSL2600110 GlaxoSmithKline Trading Services Limited; GlaxoSmithKline (China) Investment Company Limited
2026/05/08Import · Class 1 注射用BMS-986525 · No verified English nameJXSL2600109 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/05/08Import · Class 1 Elecoglipron薄膜包衣片 · No verified English nameJXHL2600157 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/08Import · Class 1 Elecoglipron薄膜包衣片 · No verified English nameJXHL2600156 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/08Import · Class 1 Elecoglipron薄膜包衣片 · No verified English nameJXHL2600155 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/08Import · Class 1 Elecoglipron薄膜包衣片 · No verified English nameJXHL2600154 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/08Import · Class 1 Elecoglipron薄膜包衣片 · No verified English nameJXHL2600153 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/08Import · Class 1 Elecoglipron薄膜包衣片 · No verified English nameJXHL2600152 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/08Import · Class 1 Elecoglipron薄膜包衣片 · No verified English nameJXHL2600151 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/08Import · Class 1 Elecoglipron薄膜包衣片 · No verified English nameJXHL2600150 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/08Import · Class 1 LY4337713注射液 · No verified English nameJXHL2600149 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/05/08Import · Class 1 Elecoglipron薄膜包衣片 · No verified English nameJXHL2600148 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/08Import · Class 1 Elecoglipron薄膜包衣片 · No verified English nameJXHL2600147 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/08Import · Class 1 Elecoglipron薄膜包衣片 · No verified English nameJXHL2600146 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/08Import · Class 1 Elecoglipron薄膜包衣片 · No verified English nameJXHL2600145 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/08Import · Class 1 Elecoglipron薄膜包衣片 · No verified English nameJXHL2600144 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/08Import · Class 1 Elecoglipron薄膜包衣片 · No verified English nameJXHL2600143 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/08Import · Class 1 Elecoglipron薄膜包衣片 · No verified English nameJXHL2600142 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/08Import · Class 1 Elecoglipron薄膜包衣片 · No verified English nameJXHL2600141 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/08Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2601057 CSPC OUYI PHARMACEUTICAL CO., LTD.
2026/05/08Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2601054 Hebei Guang Xiang Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2026/05/08Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601042 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2026/05/08Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601040 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2026/05/08Generic · Class 3 Piracetam InjectionCYHS2601035 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/05/08Generic · Class 3 Piracetam InjectionCYHS2601034 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/05/08New drug · Class 1 SYS6067注射液 · No verified English nameCXSL2600483 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/05/08New drug · Class 1 SQ-23101注射液 · No verified English nameCXSL2600482 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2026/05/08New drug · Class 1 注射用3SC001 · No verified English nameCXSL2600481 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2026/05/08New drug · Class 1 OTOV-102预混注射液 · No verified English nameCXSL2600479 Xing Ao Tuo Wei (Nanjing) Bio Technology Co., Ltd. romanized

38 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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