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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 352 drug applications between 16 September 2025 and 22 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 92, covering 69 drug names.

2025/09/16 – 2025/09/22

Period
2025/09/16 to 2025/09/22, 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
352
Drugs with new generic filings (by drug name, de-duplicated)
69
Accepted this week, now under review
110

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

352filings, 92 of them generic

By application type

Application typeFilings
Supplement176
Generic92
New drug47
Import28
Import re-registration7
Unspecified2

By drug type

Drug typeFilings
Chemical drug182
TCM81
Therapeutic biologic80
Prophylactic biologic7
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

69 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Loxoprofen Sodium Patches4230
2Palbociclib Capsules310
3注射用泼尼松龙琥珀酸钠 · No verified English name313
4Buspirone Hydrochloride Tablets315
5Lidocaine and Tetracaine Cream222
6Glucosamine Sulfate Capsules2251
7Montelukast Sodium Chewable Tablets214
8Levocarnitine Oral Solution219
9Brexpiprazole Orally Disintegrating Tablets2110
10Brexpiprazole Tablets2131

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

218 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Si Huan Biopharmaceutical Co., Ltd. romanized1010
2AstraZeneca AB850
3Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized770
4Gansu Fu Zheng Pharma Technology Co., Ltd. romanized760
5Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized720
6Shenyang San Sheng Pharmaceutical Co., Ltd. romanized620
7Novartis Pharma AG520
8Shanghai Joint Sai Er Bio Gong Cheng Co., Ltd. romanized520
9Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized520
10Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized525

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

99 this week

AcceptedDrugApplicants
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
2025/09/19Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2503469 Guangzhou Ju Li Pharmaceuticals Kai Fa Co., Ltd. romanized; Guangdong Zhong Sheng Pharma Co., Ltd. romanized
2025/09/19Generic · Class 3 Doxycycline Hyclate for InjectionCYHS2503467 Hubei Mei Lin Pharma Co., Ltd. romanized
2025/09/19Generic · Class 3 Lidocaine and Tetracaine CreamCYHS2503466 Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanized
2025/09/19Generic · Class 3 Vitamin K1 InjectionCYHS2503464 Jiangsu Jiu Xu Pharma Co., Ltd. romanized
2025/09/19New drug · Class 1.1 参苏止咳颗粒 · No verified English nameCXZL2500083 Yu Sen (Jiangxi) Xin Yao Research and Development Co., Ltd. romanized
2025/09/19New drug · Class 3.3 阿柏西普眼内注射溶液 · No verified English nameCXSS2500098 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized; Jiangsu Tai Kang Biopharmaceuticals Co., Ltd. romanized
2025/09/19New drug · Class 1 泰卡西单抗注射液 · No verified English nameCXSS2500097 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized; Xin Li Tai (Suzhou) Pharma Co., Ltd. romanized
2025/09/19New drug · Class 1 泰卡西单抗注射液 · No verified English nameCXSS2500096 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized; Xin Li Tai (Suzhou) Pharma Co., Ltd. romanized
2025/09/19New drug · Class 1 注射用SSGJ-709 · No verified English nameCXSL2500806 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/09/19New drug · Class 1.2 冻干带状疱疹病毒mRNA疫苗 · No verified English nameCXSL2500805 Beijing Wo Sen Innovation Bio Technology Co., Ltd. romanized; Yunnan Yi Miao Laboratory Co., Ltd. romanized; Fu Dan University romanized; Shanghai Lan Que Biopharmaceuticals Co., Ltd. romanized; Yu Xi Wo Sen Bio Technology Co., Ltd. romanized
2025/09/19New drug · Class 1.2 冻干带状疱疹病毒mRNA疫苗 · No verified English nameCXSL2500804 Beijing Wo Sen Innovation Bio Technology Co., Ltd. romanized; Yunnan Yi Miao Laboratory Co., Ltd. romanized; Fu Dan University romanized; Shanghai Lan Que Biopharmaceuticals Co., Ltd. romanized; Yu Xi Wo Sen Bio Technology Co., Ltd. romanized
2025/09/19New drug · Class 2.2 注射用苏维西塔单抗 · No verified English nameCXSL2500803 Jiangsu Xian Sheng Biopharmaceutical Co., Ltd. romanized

69 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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