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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 297 drug applications between 13 November 2022 and 19 November 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 38 drug names.

2022/11/13 – 2022/11/19

Period
2022/11/13 to 2022/11/19, 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
297
Drugs with new generic filings (by drug name, de-duplicated)
38
Accepted this week, now under review
0

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

297filings, 51 of them generic

By application type

Application typeFilings
Supplement179
Generic51
New drug38
Import14
Unspecified8
Import re-registration7

By drug type

Drug typeFilings
Chemical drug221
TCM48
Therapeutic biologic28

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

38 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Palbociclib Capsules310
2Lidocaine Hydrochloride Injection316
3Sitagliptin Phosphate Tablets312
4Tadalafil Tablets2123
5Lamotrigine Tablets210
6Sildenafil Citrate Tablets2112
7Esomeprazole Sodium for Injection211
8Procaterol Hydrochloride Oral Solution2112
9Escitalopram Oxalate Tablets216
10Dapagliflozin Tablets2184

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

157 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng Shang Cheng Pharma Co., Ltd. romanized17130
2Henan Shuang He Hua Li Pharma Co., Ltd. romanized1230
3Jiangxi Ren Ke Pharmaceuticals Technology Co., Ltd. romanized990
4Hefei Hua Fang Pharmaceuticals Technology Co., Ltd. romanized770
5GE Healthcare AS710
6Boehringer Ingelheim International GmbH610
7Shenzhen Xin Li Tai Pharma Co., Ltd. romanized610
8Hua Run San Jiu (Chen Zhou) Pharmaceutical Co., Ltd. romanized550
9Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized540
10UCB Pharma SA520

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

61 this week

AcceptedDrugApplicants
2022/11/19Import · Class 1 BAY 2433334片 · No verified English nameJXHL2200339 Bayer AG; Bayer Healthcare Company Ltd.
2022/11/19Generic · Class 3 注射用泮托拉唑钠(Ⅰ) · No verified English nameCYHS2202017 Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Guangdong Long Fu Pharma Co., Ltd. romanized
2022/11/19New drug · Class 1 SAL0119片 · No verified English nameCXHL2200915 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/11/19New drug · Class 1 SAL0119片 · No verified English nameCXHL2200914 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/11/19New drug · Class 1 SAL0119片 · No verified English nameCXHL2200913 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/11/19New drug · Class 1 SAL0119片 · No verified English nameCXHL2200912 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/11/19New drug · Class 1 SAL0119片 · No verified English nameCXHL2200911 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/11/19New drug · Class 1 SAL0119片 · No verified English nameCXHL2200910 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2022/11/19New drug · Class 1 BR1733片 · No verified English nameCXHL2200909 Shanghai Qing Yu Pharmaceuticals Technology Co., Ltd. romanized
2022/11/19New drug · Class 1 BR1733片 · No verified English nameCXHL2200908 Shanghai Qing Yu Pharmaceuticals Technology Co., Ltd. romanized
2022/11/19New drug · Class 1 KF-0210片 · No verified English nameCXHL2200907 Kai Fu (Suzhou) Biopharmaceuticals Co., Ltd. romanized
2022/11/19New drug · Class 1 KF-0210片 · No verified English nameCXHL2200906 Kai Fu (Suzhou) Biopharmaceuticals Co., Ltd. romanized
2022/11/18Generic · Class 3 Naloxone Hydrochloride InjectionCYHS2202015 Chongqing Lai Mei Pharma Co., Ltd. romanized
2022/11/18Generic · Class 3 头孢克肟颗粒 · No verified English nameCYHS2201935 Hefei En Rui Te Pharma Co., Ltd. romanized; Anhui An Ke Heng Yi Pharma Co., Ltd. romanized
2022/11/18New drug · Class 3.4 人凝血酶原复合物 · No verified English nameCXSS2200091 Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized
2022/11/18New drug · Class 1 注射用IMM0306 · No verified English nameCXSL2200583 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2022/11/18New drug · Class 1 注射用PRO1184 · No verified English nameCXSL2200582 Pu Fang Biopharmaceutical (Suzhou) Co., Ltd. romanized
2022/11/18New drug · Class 1 ELPIS人脐带间充质干细胞注射液 · No verified English nameCXSL2200581 Hua Xia Yuan (Shanghai) Bio Technology Co., Ltd. romanized
2022/11/17Generic · Class 3 Digoxin InjectionCYHS2202003 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2022/11/17Generic · Class 3 Formoterol Fumarate Inhalation SolutionCYHS2202000 Shanghai Ao Ke Da Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2022/11/17New drug · Class 1.1 金连消风颗粒 · No verified English nameCXZL2200052 Ying Ke Rui (Tianjin) Innovation Pharmaceuticals Research Co., Ltd. romanized
2022/11/17New drug · Class 1 注射用BB-1709 · No verified English nameCXSL2200580 Bai Li Si Kang Biopharmaceuticals (Hangzhou) Co., Ltd. romanized
2022/11/17New drug · Class 2.2 普特利单抗注射液 · No verified English nameCXSL2200578 Le Pu Bio Technology Co., Ltd. romanized
2022/11/17New drug · Class 1 GC012F注射液 · No verified English nameCXSL2200577 Suzhou Gen Xi Bio Technology Co., Ltd. romanized; Gen Xi Bio Technology (Shanghai) Co., Ltd. romanized
2022/11/17New drug · Class 2.2 马来酸噻吗洛尔乳膏 · No verified English nameCXHL2200905 Shanghai Fu Dan Zhang Jiang Biopharmaceuticals Co., Ltd. romanized
2022/11/17New drug · Class 1 BEBT-503胶囊 · No verified English nameCXHL2200904 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized
2022/11/17New drug · Class 1 BEBT-503胶囊 · No verified English nameCXHL2200903 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized
2022/11/17New drug · Class 1 WS012干混悬剂 · No verified English nameCXHL2200902 Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized
2022/11/16Import · Class 3.1 司库奇尤单抗注射液 · No verified English nameJXSS2200036 Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd.
2022/11/16Import · Class 3.1 司库奇尤单抗注射液 · No verified English nameJXSS2200035 Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd.

31 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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