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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 496 drug applications between 1 February 2024 and 7 February 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 157, covering 121 drug names.

2024/02/01 – 2024/02/07

Period
2024/02/01 to 2024/02/07, 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
496
Drugs with new generic filings (by drug name, de-duplicated)
121
Accepted this week, now under review
8

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

496filings, 157 of them generic

By application type

Application typeFilings
Supplement197
Generic157
New drug83
Import31
Unspecified14
Import re-registration14

By drug type

Drug typeFilings
Chemical drug359
Therapeutic biologic72
TCM54
Prophylactic biologic6
Biologic5

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

121 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets4323
2Diprophylline Injection337
3Sacubitril Valsartan Sodium Tablets3170
4LevomilnacipranHydrochloride Extended-release Capsules316
5Lidocaine and Prilocaine Cream2224
6Gatifloxacin Eye Drops223
7Fusidic Acid Cream2215
8Dronedarone Hydrochloride Tablets224
9盐酸左沙丁胺醇雾化吸入溶液 · No verified English name222
10Metoclopramide Hydrochloride Injection226

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

306 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shijiazhuang No.4 Pharmaceutical Co., Ltd.775
2Sichuan Yi Ke Cao Pharma Co., Ltd. romanized660
3Hui Yin Bi Group Jiangxi Dong Ya Pharmaceutical Co., Ltd. romanized650
4Shandong Xin Shi Dai Pharma Co., Ltd. romanized655
5Jiangsu En Hua Pharma Co., Ltd. romanized634
6AbbVie Inc.620
7Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized610
8Bayer AG540
9Pfizer Europe MA EEIG530
10Sichuan Kelun Pharmaceutical Co., Ltd.533

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

176 this week

AcceptedDrugApplicants
2024/02/07Import · Class 2.2 Lebrikizumab注射液 · No verified English nameJXSL2400042 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/02/07Generic · Class 3 Potassium Chloride InjectionCYHS2400563 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/02/07Generic · Class 3 Nicorandil for InjectionCYHS2400559 Shenyang Xin Ma Pharma Co., Ltd. romanized
2024/02/07Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2400557 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2024/02/07Generic · Class 3 Propafenone Hydrochloride InjectionCYHS2400556 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2024/02/07Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2400555 Sichuan Shang Shan Liu Jing Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2024/02/07Generic · Class 3 Magnesium Sulfate InjectionCYHS2400554 Hebei Yi Pin Pharmaceutical Co., Ltd. romanized
2024/02/07Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2400548 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2024/02/07Generic · Class 3 Potassium Chloride Extended Release TabletsCYHS2400544 YaoPharma Co., Ltd.
2024/02/07Generic · Class 3 盐酸丙卡特罗片 · No verified English nameCYHS2400542 Nanjing Ji Cui Ji Ding Pharmaceuticals Co., Ltd. romanized
2024/02/07Generic · Class 3 水溶性黄体酮注射液 · No verified English nameCYHS2400541 Shijiazhuang No.4 Pharmaceutical Co., Ltd.; Henan Ke Lun Pharma Co., Ltd. romanized
2024/02/07New drug · Class 1 SHR-1905注射液 · No verified English nameCXSL2400109 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2024/02/07New drug · Class 1 注射用QLF31907 · No verified English nameCXSL2400108 Qilu Pharmaceutical Co., Ltd.
2024/02/07New drug · Class 1 LNF2008单克隆抗体注射液 · No verified English nameCXSL2400107 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2024/02/07New drug · Class 1 AK129注射液 · No verified English nameCXSL2400106 Kang Fang Hui Ke (Shanghai) Bio Co., Ltd. romanized
2024/02/07New drug · Class 3.3 德谷胰岛素利拉鲁肽注射液 · No verified English nameCXSL2400105 Tong Hua Dong Bao Pharma Co., Ltd. romanized
2024/02/07New drug · Class 1 玛仕度肽注射液 · No verified English nameCXHS2400010 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/02/07New drug · Class 1 玛仕度肽注射液 · No verified English nameCXHS2400009 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/02/07New drug · Class 1 玛仕度肽注射液 · No verified English nameCXHS2400008 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/02/07New drug · Class 1 TQB3117片 · No verified English nameCXHL2400172 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/02/07New drug · Class 1 TQB3117片 · No verified English nameCXHL2400171 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/02/07New drug · Class 1 SIM0506胶囊 · No verified English nameCXHL2400170 Shanghai Xian Xiang Pharmaceuticals Technology Co., Ltd. romanized
2024/02/07New drug · Class 1 SIM0506胶囊 · No verified English nameCXHL2400169 Shanghai Xian Xiang Pharmaceuticals Technology Co., Ltd. romanized
2024/02/06Import · Class 3.1 美泊利珠单抗注射液 · No verified English nameJXSS2400010 GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited
2024/02/06Import · Class 3.1 美泊利珠单抗注射液 · No verified English nameJXSS2400009 GlaxoSmithKline Trading Services Limited; Glaxo Operations UK Ltd.; GlaxoSmithKline (China) Investment Company Limited
2024/02/06Import · Class 3.1 注射用戈沙妥珠单抗 · No verified English nameJXSS2400008 Gilead Sciences Inc.; BSP Pharmaceuticals S.p.A.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2024/02/06Import · Class 2.2 Lebrikizumab注射液 · No verified English nameJXSL2400041 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2024/02/06Import · Class 2.2 Risankizumab注射液 · No verified English nameJXSL2400040 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/02/06Import · Class 2.2 Risankizumab注射液 · No verified English nameJXSL2400039 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2024/02/06Import · Class 2.2 Risankizumab注射液 · No verified English nameJXSL2400038 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.

146 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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