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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 345 drug applications between 13 September 2025 and 19 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 87, covering 69 drug names.

2025/09/13 – 2025/09/19

Period
2025/09/13 to 2025/09/19, 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
345
Drugs with new generic filings (by drug name, de-duplicated)
69
Accepted this week, now under review
112

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

345filings, 87 of them generic

By application type

Application typeFilings
Supplement170
Generic87
New drug49
Import27
Unspecified6
Import re-registration6

By drug type

Drug typeFilings
Chemical drug173
Therapeutic biologic83
TCM75
Prophylactic biologic8
Biologic5
In vitro diagnostic reagent1

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
1Buspirone Hydrochloride Tablets315
2Lidocaine and Tetracaine Cream222
3利伐沙班颗粒 · No verified English name212
4Montelukast Sodium Chewable Tablets214
5Levocarnitine Injection214
6Brexpiprazole Orally Disintegrating Tablets2110
7Brexpiprazole Tablets2131
8Flomoxef Sodium for Injection219
9Loxoprofen Sodium Patches2130
10环硅酸锆钠散 · No verified English name2112

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

203 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Si Huan Biopharmaceutical Co., Ltd. romanized1010
2Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized830
3Jilin Fei Nuo Pharmaceutical Co., Ltd. romanized770
4Gansu Fu Zheng Pharma Technology Co., Ltd. romanized760
5AstraZeneca AB750
6Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized720
7Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized630
8Shenyang San Sheng Pharmaceutical Co., Ltd. romanized620
9Yunnan Yong Zi Tang Pharmaceutical Co., Ltd. romanized550
10Novartis Pharma AG520

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

102 this week

AcceptedDrugApplicants
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
2025/09/19New drug · Class 1 HLX37注射液 · No verified English nameCXSL2500802 Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2025/09/19New drug · Class 1 TQF3250胶囊 · No verified English nameCXHL2501018 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2025/09/19New drug · Class 1 TQF3250胶囊 · No verified English nameCXHL2501017 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2025/09/19New drug · Class 1 TQF3250胶囊 · No verified English nameCXHL2501016 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2025/09/18Import · Class 1 CVM-1118胶囊 · No verified English nameJXHL2500294 TaiRx Inc.; TaiRx Pharmaceutical (Kunshan). Ltd.
2025/09/18Import · Class 2.2; 2.4 双醋瑞因软膏 · No verified English nameJXHL2500293 TWi Biotechnology Inc.; Hangzhou Tigermed Consulting Co. Ltd.
2025/09/18Generic · Class 3 Nefopam Hydrochloride InjectionCYHS2503457 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2025/09/18Generic · Class 3 Diphenhydramine Hydrochloride InjectionCYHS2503453 Sichuan Tian Xing Hui Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized
2025/09/18Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2503451 Yan Tai Ju Xian Pharma Co., Ltd. romanized
2025/09/18Generic · Class 3 Brexpiprazole Orally Disintegrating TabletsCYHS2503450 Yan Tai Ju Xian Pharma Co., Ltd. romanized
2025/09/18Generic · Class 3 Trihexyphenidyl Hydrochloride TabletsCYHS2503445 Yun Peng Pharmaceuticals Group Co., Ltd. romanized
2025/09/18Generic · Class 3 Sodium Nitroprusside InjectionCYHS2503444 Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized
2025/09/18Generic · Class 3 盐酸羟甲唑啉滴眼液 · No verified English nameCYHL2500170 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2025/09/18Generic · Class 3 酮洛芬凝胶贴膏 · No verified English nameCYHL2500169 Fu Yuan Pharma Co., Ltd. romanized
2025/09/18New drug · Class 3.1 半夏白术天麻颗粒 · No verified English nameCXZS2500040 Hainan Si Da Pharmaceutical Co., Ltd. romanized; Anhui Hong Xin Pharma Development Co., Ltd. romanized
2025/09/18New drug · Class 3.1 芍药甘草颗粒 · No verified English nameCXZS2500039 Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized
2025/09/18New drug · Class 2 人细小病毒B19核酸检测试剂盒(PCR-荧光法) · No verified English nameCXSS2500095 Beijing Wan Tai Bio Pharma Co., Ltd. romanized

72 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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