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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 293 drug applications between 17 September 2025 and 23 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 74, covering 57 drug names.

2025/09/17 – 2025/09/23

Period
2025/09/17 to 2025/09/23, 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
293
Drugs with new generic filings (by drug name, de-duplicated)
57
Accepted this week, now under review
81

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

293filings, 74 of them generic

By application type

Application typeFilings
Supplement140
Generic74
New drug47
Import24
Import re-registration6
Unspecified2

By drug type

Drug typeFilings
Chemical drug161
TCM71
Therapeutic biologic53
Prophylactic biologic6
In vitro diagnostic reagent1
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

57 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Palbociclib Capsules310
2注射用泼尼松龙琥珀酸钠 · No verified English name313
3Lidocaine and Tetracaine Cream222
4Menatetrenone Soft Capsules224
5Glucosamine Sulfate Capsules2251
6Montelukast Sodium Chewable Tablets214
7Levocarnitine Oral Solution219
8Brexpiprazole Orally Disintegrating Tablets2110
9Brexpiprazole Tablets2131
10Flomoxef Sodium for Injection219

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

199 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized770
2Gansu Fu Zheng Pharma Technology Co., Ltd. romanized760
3AstraZeneca AB640
4Novartis Pharma AG520
5Shanghai Joint Sai Er Bio Gong Cheng Co., Ltd. romanized520
6Zhong Jing Wan Xi Pharmaceutical Co., Ltd. romanized330
7Eli Lilly and Company320
8Sichuan Kelun Pharmaceutical Co., Ltd.320
9Guangzhou Nuo Jin Pharmaceutical Co., Ltd. romanized320
10Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized322

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

91 this week

AcceptedDrugApplicants
2025/09/23Import · Class 2.2 艾可瑞妥单抗注射液 · No verified English nameJXSS2500128 AbbVie Deutschland GmbH & Co. KG; Vetter Pharma-Fertigung GmbH & Co. KG; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/09/23Import · Class 2.2 艾可瑞妥单抗注射液 · No verified English nameJXSS2500127 AbbVie Deutschland GmbH & Co. KG; Vetter Pharma-Fertigung GmbH & Co. KG; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2025/09/23Generic · Class 3 布美他尼片 · No verified English nameCYHS2503490 Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized; Sichuan Sai Zhuo Pharma Co., Ltd. romanized
2025/09/23Generic · Class 3 Lidocaine Hydrochloride GelCYHS2503489 Sichuan Sheng Yu Xin Pharma Co., Ltd. romanized; Tong Fang Pharma (Beijing) Co., Ltd. romanized
2025/09/23New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSS2500099 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized; Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/09/23New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2500814 You Sai Sheng Ming Ke Xue Development Co., Ltd. romanized
2025/09/23New drug · Class 1 注射用ATG-022 ADC · No verified English nameCXSL2500813 De Qi (Hangzhou) Bio Co., Ltd. romanized
2025/09/23New drug · Class 1 SHR7280片 · No verified English nameCXHS2500118 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2025/09/23New drug · Class 1 RSS0343片 · No verified English nameCXHL2501023 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2025/09/23New drug · Class 1 RSS0343片 · No verified English nameCXHL2501022 Rui Shi Biopharmaceuticals Co., Ltd. romanized
2025/09/23New drug · Class 1 XRF-1021片 · No verified English nameCXHL2501021 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/09/23New drug · Class 1 XRF-1021片 · No verified English nameCXHL2501020 Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized
2025/09/22Import · Class 2.4 Osimertinib Mesylate TabletsJXHS2500108 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/09/22Import · Class 2.4 Osimertinib Mesylate TabletsJXHS2500107 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/09/22Import · Class 1 LY3537021注射液 · No verified English nameJXHL2500295 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd
2025/09/22New drug · Class 3.3 QL2110注射液 · No verified English nameCXSL2500812 Qilu Pharmaceutical Co., Ltd.
2025/09/22New drug · Class 3.3 QL2110注射液 · No verified English nameCXSL2500811 Qilu Pharmaceutical Co., Ltd.
2025/09/22New drug · Class 1 富马酸仑博替尼胶囊 · No verified English nameCXHS2500120 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/09/22New drug · Class 1 富马酸仑博替尼胶囊 · No verified English nameCXHS2500119 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2025/09/22New drug · Class 1 注射用GMDTC · No verified English nameCXHL2501019 Guangzhou Jian Er Sheng Pharmaceuticals Technology Co., Ltd. romanized
2025/09/20Generic · Class 3 Minoxidil LinimentCYHS2503477 Hainan Jun Hua Medical Technology Co., Ltd. romanized; Beijing Jing Feng Pharmaceutical (Hebei) Co., Ltd. romanized
2025/09/20Generic · Class 3 注射用泼尼松龙琥珀酸钠 · No verified English nameCYHL2500173 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized
2025/09/20Generic · Class 3 注射用泼尼松龙琥珀酸钠 · No verified English nameCYHL2500172 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized
2025/09/20Generic · Class 3 注射用泼尼松龙琥珀酸钠 · No verified English nameCYHL2500171 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized
2025/09/20New drug · Class 1.1 柴芍解郁颗粒 · No verified English nameCXZL2500084 Heilongjiang Sheng Ji Ren Pharma Co., Ltd. romanized
2025/09/20New drug · Class 1 靶向CD19基因修饰的异体嵌合抗原受体T细胞注射液 · No verified English nameCXSL2500810 Shanghai Bang Yao Bio Technology Co., Ltd. romanized
2025/09/20New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSL2500809 Chengdu Jing Ze Biopharmaceutical Co., Ltd. romanized
2025/09/20New drug · Class 3.3 重组人促卵泡激素注射液 · No verified English nameCXSL2500808 Chengdu Jing Ze Biopharmaceutical Co., Ltd. romanized
2025/09/20New drug · Class 2.2 WGP03 · No verified English nameCXSL2500807 Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized; Shenzhen Rui Jian Sheng Ming Ke Xue Research Institute Co., Ltd. romanized
2025/09/19Import · Class 1 注射用AZD0292 · No verified English nameJXSL2500182 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd

61 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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