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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 182 drug applications between 16 March 2024 and 22 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 43, covering 35 drug names.

2024/03/16 – 2024/03/22

Period
2024/03/16 to 2024/03/22, 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
182
Drugs with new generic filings (by drug name, de-duplicated)
35
Accepted this week, now under review
1

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

182filings, 43 of them generic

By application type

Application typeFilings
Supplement88
Generic43
New drug35
Import8
Unspecified7
Import re-registration1

By drug type

Drug typeFilings
Chemical drug102
TCM51
Therapeutic biologic26
Prophylactic biologic2
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

35 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets3123
2Morinidazole and Sodium Chloride Injection229
3Perampanel Tablets212
4Bromhexine Hydrochloride Solution For Inhalation211
5Montelukast Sodium Chewable Tablets214
6Esmolol Hydrochloride and Sodium Chloride Injection210
7Sugammadex Sodium Injection216
8噻托溴铵吸入喷雾剂 · No verified English name111
9Potassium Phosphates Injection112
10Tropicamide Phenylephrine Eye Drops118

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

111 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guo Da (Jilin) Pharmaceutical Group Co., Ltd. romanized31310
2Bai Ao Tai Biopharmaceutical Co., Ltd. romanized440
3Albireo AB410
4Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized410
5Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized410
6Shenyang Hong Qi Pharmaceutical Co., Ltd. romanized321
7Hui Rui Pharmaceutical Technology Co., Ltd. romanized320
8CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD310
9Jiangsu Run Bang Pharma Co., Ltd. romanized313
10Haerbin Jun An Tang Pharmaceuticals Co., Ltd. romanized220

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

54 this week

AcceptedDrugApplicants
2024/03/22Generic · Class 3 Dopamine Hydrochloride InjectionCYHS2400892 Shanghai Xian Dai Ha Sen (Shang Qiu) Pharma Co., Ltd. romanized
2024/03/22Generic · Class 3 盐酸肾上腺素注射液 · No verified English nameCYHS2400890 Nanjing Chen Gong Pharmaceutical Co., Ltd. romanized; Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized
2024/03/22Generic · Class 3 Nicorandil for InjectionCYHS2400889 Fuzhou Hua Wei Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2024/03/22New drug · Class 3.3 四价流感病毒裂解疫苗 · No verified English nameCXSS2400027 Jiangsu Kang Run Bio Technology Co., Ltd. romanized
2024/03/22New drug · Class 1 盐酸杰克替尼片 · No verified English nameCXHL2400298 Name not romanized
2024/03/22New drug · Class 1 盐酸杰克替尼片 · No verified English nameCXHL2400297 Name not romanized
2024/03/22New drug · Class 1 YK-051 · No verified English nameCXHL2400296 Nanjing You Ke Pharmaceutical Co., Ltd. romanized
2024/03/21Generic · Class 3 Potassium Phosphates InjectionCYHS2400885 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2024/03/21Generic · Class 3 Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2400884 Beijing Foyou Pharma CO.,LTD
2024/03/21Generic · Class 3 Raltitrexed for InjectionCYHS2400880 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
2024/03/21Generic · Class 3 Isoprenaline Hydrochloride InjectionCYHS2400879 Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized
2024/03/21New drug · Class 1 GCB-001 · No verified English nameCXSL2400199 Shanghai Jin Ke Bo Bio Technology Co., Ltd. romanized
2024/03/21New drug · Class 1 BAT7104注射液 · No verified English nameCXSL2400198 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2024/03/21New drug · Class 1 注射用BAT8008 · No verified English nameCXSL2400197 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2024/03/20Import · Class 1 LY3819469注射液 · No verified English nameJXHL2400066 Eli Lilly and Company
2024/03/20New drug · Class 1.1 柴桂解感颗粒 · No verified English nameCXZL2400016 Shandong Zhong Pharmaceuticals University romanized; Shandong Gu Jin Zhong Pharmaceuticals Technology Co., Ltd. romanized
2024/03/20New drug · Class 1 注射用DB-1305 · No verified English nameCXSL2400196 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2024/03/20New drug · Class 1 DP303c注射液 · No verified English nameCXSL2400195 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2024/03/20New drug · Class 1 DP303c注射液 · No verified English nameCXSL2400194 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2024/03/20New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2400295 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/03/20New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2400294 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/03/20New drug · Class 2.4 Anlotinib Hydrochloride CapsulesCXHL2400293 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2024/03/20New drug · Class 1 HLX99片 · No verified English nameCXHL2400292 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized
2024/03/20New drug · Class 1 HLX99片 · No verified English nameCXHL2400291 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized
2024/03/20New drug · Class 1 HLX99片 · No verified English nameCXHL2400290 Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized; Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2024/03/20New drug · Class 1 盐酸希美替尼片 · No verified English nameCXHL2400289 Zhongguo Ke College Shanghai Drug Research Institute romanized; Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/03/20New drug · Class 1 盐酸希美替尼片 · No verified English nameCXHL2400288 Zhongguo Ke College Shanghai Drug Research Institute romanized; Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized
2024/03/20New drug · Class 1 D-1553片 · No verified English nameCXHL2400287 Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized
2024/03/19Generic · Class 3 Isoniazid InjectionCYHS2400870 Shenyang Hong Qi Pharmaceutical Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized
2024/03/19Generic · Class 3 Calcium Gluconate InjectionCYHS2400869 Shijiazhuang No.4 Pharmaceutical Co., Ltd.

24 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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