YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 346 drug applications between 20 September 2023 and 26 September 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 65 drug names.

2023/09/20 – 2023/09/26

Period
2023/09/20 to 2023/09/26, 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
346
Drugs with new generic filings (by drug name, de-duplicated)
65
Accepted this week, now under review
4

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

346filings, 83 of them generic

By application type

Application typeFilings
Supplement181
Generic83
New drug58
Import16
Unspecified5
Import re-registration3

By drug type

Drug typeFilings
Chemical drug248
TCM60
Therapeutic biologic34
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

65 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
5醋酸钠林格葡萄糖注射液 · No verified English name222
6Digoxin Injection213
7Oxcarbazepine Tablets214
8Bisoprolol Fumarate Tablets216
9生理氯化钠溶液 · No verified English name2117
10Neostigmine Methylsulfate Injection214

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

206 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized1040
2Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized760
3Shen Wei Pharma Group Co., Ltd. romanized740
4Boehringer Ingelheim International GmbH610
5Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized616
6Shanxi Huang He Zhong Yao Co., Ltd. romanized540
7Novartis Europharm Limited530
8HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.520
9Jiangxi Shimei Pharmaceutical Co., Ltd442
10Hainan Ying Da Run Ze Pharma Co., Ltd. romanized430

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

106 this week

AcceptedDrugApplicants
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
2023/09/26New drug · Class 1 SHR-2002注射液 · No verified English nameCXSL2300655 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/09/26New drug · Class 1 注射用AMT-253 · No verified English nameCXSL2300654 Pu Zhong Fa Xian Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2023/09/26New drug · Class 1 MG-K10人源化单抗注射液 · No verified English nameCXSL2300653 Shanghai Mai Ji Bio Technology Co., Ltd. romanized
2023/09/26New drug · Class 1 自体肿瘤浸润淋巴细胞注射液 · No verified English nameCXSL2300652 Wuhan Yi Shou Technology Co., Ltd. romanized; Hainan Yi Shou Technology Co., Ltd. romanized
2023/09/26New drug · Class 1 维派那肽注射液 · No verified English nameCXHS2300088 Pai Ge Biopharmaceuticals (Hangzhou) Co., Ltd. romanized; Hangzhou Ao Ya Bio Technology Co., Ltd. romanized
2023/09/26New drug · Class 1 KH629片 · No verified English nameCXHL2301036 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2023/09/26New drug · Class 1 KH629片 · No verified English nameCXHL2301035 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2023/09/26New drug · Class 1 KH629片 · No verified English nameCXHL2301034 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2023/09/26New drug · Class 2.3 SMF-204 · No verified English nameCXHL2301033 Jiangxi Shimei Pharmaceutical Co., Ltd
2023/09/25Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2302585 Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized
2023/09/25Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2302584 Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized
2023/09/25New drug · Class 1.1 五味益心颗粒 · No verified English nameCXZL2300064 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2023/09/25New drug · Class 1 重组抗 Claudin18.2 全人源单克隆抗体注射液 · No verified English nameCXSL2300651 Hua Lan Ji Yin Gong Cheng (Henan) Co., Ltd. romanized
2023/09/25New drug · Class 1 SCT650C注射液 · No verified English nameCXSL2300650 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2023/09/25New drug · Class 1 HS-10516胶囊 · No verified English nameCXHL2301032 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/09/25New drug · Class 1 HS-10516胶囊 · No verified English nameCXHL2301031 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized

76 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.