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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 319 drug applications between 21 September 2023 and 27 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 58 drug names.

2023/09/21 – 2023/09/27

Period
2023/09/21 to 2023/09/27, 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
319
Drugs with new generic filings (by drug name, de-duplicated)
58
Accepted this week, now under review
3

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

319filings, 76 of them generic

By application type

Application typeFilings
Supplement162
Generic76
New drug59
Import14
Unspecified5
Import re-registration3

By drug type

Drug typeFilings
Chemical drug225
TCM52
Therapeutic biologic38
Biologic2
In vitro diagnostic reagent1
Prophylactic 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

58 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Minoxidil Liniment6152
2Sodium Hyaluronate Eye Drops3230
3Tapentadol Hydrochloride Tablets310
4Methocarbamol Injection223
5Digoxin Injection213
6Oxcarbazepine Tablets214
7Vonoprazan Fumarate Tablets2160
8Bisoprolol Fumarate Tablets216
9Pregabalin Capsules2112
10生理氯化钠溶液 · No verified English name2117

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

185 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized1040
2Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized810
3Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized760
4Shen Wei Pharma Group Co., Ltd. romanized740
5Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized630
6Boehringer Ingelheim International GmbH610
7Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized616
8Novartis Europharm Limited530
9HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.520
10Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized440

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
2023/09/27Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2302613 Jiangsu Jia You Pharma Group Co., Ltd. romanized; Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized
2023/09/27New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSS2300085 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized
2023/09/27New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSS2300084 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized
2023/09/27New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSS2300083 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized
2023/09/27New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSS2300082 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized
2023/09/27New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSS2300081 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized
2023/09/27New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSS2300080 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized
2023/09/27New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSS2300079 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized
2023/09/27New drug · Class 1 苏帕鲁肽注射液 · No verified English nameCXSS2300078 Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized
2023/09/27New drug · Class 1 RJMty19注射液 · No verified English nameCXSL2300661 Zhejiang Rui Jia Mei Bio Technology Co., Ltd. romanized
2023/09/27New drug · Class 1 GC012F注射液 · No verified English nameCXSL2300660 Suzhou Gen Xi Bio Technology Co., Ltd. romanized; Gen Xi Bio Technology (Shanghai) Co., Ltd. romanized
2023/09/27New drug · Class 1 HGI-001注射液 · No verified English nameCXSL2300659 Shenzhen Shi He Mu Ji Yin Bio Technology Co., Ltd. romanized
2023/09/27New drug · Class 2.4 注射用重组A型肉毒毒素 · No verified English nameCXSL2300658 Jun He Meng Biopharmaceutical (Tong Hua) Co., Ltd. romanized
2023/09/27New drug · Class 2.4 脯氨酸恒格列净片 · No verified English nameCXHS2300090 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/09/27New drug · Class 2.4 脯氨酸恒格列净片 · No verified English nameCXHS2300089 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/09/27New drug · Class 1 注射用JMKX003801 · No verified English nameCXHL2301037 Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized
2023/09/26Generic · Class 3 Minoxidil LinimentCYHS2302604 Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd.
2023/09/26Generic · Class 3 Minoxidil LinimentCYHS2302602 Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd.
2023/09/26Generic · Class 3 Minoxidil LinimentCYHS2302601 Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd.
2023/09/26Generic · Class 3 Minoxidil LinimentCYHS2302600 Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd.
2023/09/26Generic · Class 3 Minoxidil LinimentCYHS2302599 Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd.
2023/09/26Generic · Class 3 Minoxidil LinimentCYHS2302598 Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd.
2023/09/26Generic · Class 3 醋酸钠林格葡萄糖注射液 · No verified English nameCYHS2302597 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/09/26Generic · Class 3 Diprophylline InjectionCYHS2302596 Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized
2023/09/26Generic · Class 3 萘普生钠软胶囊 · No verified English nameCYHS2302595 Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized; Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized
2023/09/26Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2302594 Beijing Hai Yi Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2023/09/26Generic · Class 3 Doxofylline TabletsCYHS2302593 Shanghai Kai Bao Xin Yi (Xin Xiang) Pharma Co., Ltd. romanized
2023/09/26Generic · Class 3 Pregabalin Oral SolutionCYHS2302592 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED
2023/09/26New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2300657 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/09/26New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2300656 Shenzhen Shi Yin Guan Bio Technology 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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