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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 254 drug applications between 14 March 2024 and 20 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 56, covering 42 drug names.

2024/03/14 – 2024/03/20

Period
2024/03/14 to 2024/03/20, 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
254
Drugs with new generic filings (by drug name, de-duplicated)
42
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

254filings, 56 of them generic

By application type

Application typeFilings
Supplement122
Generic56
New drug46
Import re-registration11
Unspecified10
Import9

By drug type

Drug typeFilings
Chemical drug162
TCM51
Therapeutic biologic33
Biologic6
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

42 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
6Cefditoren Pivoxil Granules2118
7Montelukast Sodium Chewable Tablets214
8小儿复方氨基酸注射液(19AA-I) · No verified English name212
9Esmolol Hydrochloride and Sodium Chloride Injection210
10Amlodipine Besylate Tablets218

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

139 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guo Da (Jilin) Pharmaceutical Group Co., Ltd. romanized26260
2Henan Shuang He Hua Li Pharma Co., Ltd. romanized1430
3Hui Rui Pharma (Hubei) Co., Ltd. romanized760
4Shijiazhuang No.4 Pharmaceutical Co., Ltd.643
5Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized410
6Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized410
7Hainan Ling Kang Pharmaceutical Co., Ltd. romanized410
8Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized410
9Boehringer Ingelheim International GmbH330
10SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED320

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

72 this week

AcceptedDrugApplicants
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
2024/03/19New drug · Class 1 GB08注射液 · No verified English nameCXSL2400190 Shenzhen Ke Xing Pharma Co., Ltd. romanized
2024/03/19New drug · Class 1 177Lu-LNC1010注射液 · No verified English nameCXHL2400286 Yan Tai Lan Na Cheng Bio Technology Co., Ltd. romanized
2024/03/18Generic · Class 3 氯化钙注射液 · No verified English nameCYHS2400865 Guangzhou Ai Ge Bio Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2024/03/18Generic · Class 3 Salbutamol Sulfate injectionCYHS2400862 Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized
2024/03/18Generic · Class 3 Propranolol Hydrochloride TabletsCYHS2400861 Hefei Guo Yao Nuo He Pharma Co., Ltd. romanized; Hua Yi Pharma Technology (Anhui) Co., Ltd. romanized
2024/03/16Import · Class 1 注射用Datopotamab Deruxtecan · No verified English nameJXSS2400026 Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO (CHINA) HOLDINGS CO. LTD.
2024/03/16Import · Class 1 ABBV-400注射用粉末 · No verified English nameJXSL2400060 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.

42 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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