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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 233 drug applications between 15 March 2024 and 21 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 53, covering 41 drug names.

2024/03/15 – 2024/03/21

Period
2024/03/15 to 2024/03/21, 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
233
Drugs with new generic filings (by drug name, de-duplicated)
41
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

233filings, 53 of them generic

By application type

Application typeFilings
Supplement123
Generic53
New drug34
Unspecified10
Import8
Import re-registration5

By drug type

Drug typeFilings
Chemical drug139
TCM55
Therapeutic biologic32
Biologic5
Prophylactic biologic2

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

41 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets6223
2Ethyl Iosapentate Capsules2127
3Carbidopa and Levodopa Sustained-release Tablets212
4Perampanel Tablets212
5Bromhexine Hydrochloride Solution For Inhalation211
6Montelukast Sodium Chewable Tablets214
7Esmolol Hydrochloride and Sodium Chloride Injection210
8Amlodipine Besylate Tablets218
9Lactulose Oral Solution1134
10Morinidazole and Sodium Chloride Injection119

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

131 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guo Da (Jilin) Pharmaceutical Group Co., Ltd. romanized31310
2Henan Shuang He Hua Li Pharma Co., Ltd. romanized1430
3Bai Ao Tai Biopharmaceutical Co., Ltd. romanized440
4Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized410
5Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized410
6Hainan Ling Kang Pharmaceutical Co., Ltd. romanized410
7Shenyang Hong Qi Pharmaceutical Co., Ltd. romanized321
8Hui Rui Pharmaceutical Technology Co., Ltd. romanized320
9IPSEN PHARMA310
10CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD310

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

57 this week

AcceptedDrugApplicants
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.
2024/03/19Generic · Class 3 Famotidine InjectionCYHS2400866 Jiangsu Lianhuan Pharmaceutical Co.,Ltd.
2024/03/19Generic · Class 3 Bromhexine Hydrochloride Solution For InhalationCYHL2400062 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2024/03/19Generic · Class 3 Bromhexine Hydrochloride Solution For InhalationCYHL2400061 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2024/03/19Generic · Class 3 Pimavanserin Tartrate CapsulesCYHL2400060 Jiangsu Ai Li Kang Pharmaceuticals Technology Co., Ltd. romanized
2024/03/19New drug · Class 1 QL1706注射液 · No verified English nameCXSL2400193 Qilu Pharmaceutical Co., Ltd.
2024/03/19New drug · Class 1 注射用QLS31905 · No verified English nameCXSL2400192 Qilu Pharmaceutical Co., Ltd.
2024/03/19New drug · Class 1 注射用YL211 · No verified English nameCXSL2400191 Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized

27 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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