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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 247 drug applications between 13 March 2024 and 19 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 63, covering 45 drug names.

2024/03/13 – 2024/03/19

Period
2024/03/13 to 2024/03/19, 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
247
Drugs with new generic filings (by drug name, de-duplicated)
45
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

247filings, 63 of them generic

By application type

Application typeFilings
Supplement109
Generic63
New drug38
Import re-registration15
Unspecified11
Import11

By drug type

Drug typeFilings
Chemical drug166
TCM43
Therapeutic biologic28
Biologic6
Prophylactic biologic4

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

45 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Amlodipine Besylate Tablets428
2Methotrexate Injection3211
3Tadalafil Tablets3123
4Famotidine Injection228
5Ethyl Iosapentate Capsules2127
6Carbidopa and Levodopa Sustained-release Tablets212
7Perampanel Tablets212
8Bromhexine Hydrochloride Solution For Inhalation211
9Cefditoren Pivoxil Granules2118
10Montelukast Sodium Chewable Tablets214

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

138 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Guo Da (Jilin) Pharmaceutical Group Co., Ltd. romanized16160
2Henan Shuang He Hua Li Pharma Co., Ltd. romanized1430
3Hui Rui Pharma (Hubei) Co., Ltd. romanized760
4Shijiazhuang No.4 Pharmaceutical Co., Ltd.753
5Dr. Falk Pharma GmbH410
6Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized410
7Hainan Ling Kang Pharmaceutical Co., Ltd. romanized410
8Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized410
9Boehringer Ingelheim International GmbH330
10Novartis Pharma Schweiz AG320

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

68 this week

AcceptedDrugApplicants
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.
2024/03/16New drug · Class 2.2 聚乙二醇干扰素α-2b注射液 · No verified English nameCXSS2400026 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2024/03/16New drug · Class 2.2 聚乙二醇干扰素α-2b注射液 · No verified English nameCXSS2400025 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2024/03/16New drug · Class 2.2 聚乙二醇干扰素α-2b注射液 · No verified English nameCXSS2400024 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2024/03/16New drug · Class 2.2 聚乙二醇干扰素α-2b注射液 · No verified English nameCXSS2400023 Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized
2024/03/16New drug · Class 1 注射用苏维西塔单抗 · No verified English nameCXSS2400022 Jiangsu Xian Sheng Biopharmaceutical Co., Ltd. romanized
2024/03/16New drug · Class 1 BAT6005注射液 · No verified English nameCXSL2400189 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2024/03/16New drug · Class 1 BAT1308注射液 · No verified English nameCXSL2400188 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2024/03/16New drug · Class 1.2 呼吸道合胞病毒IN006二价mRNA疫苗 · No verified English nameCXSL2400187 Shenzhen Shen Xin Bio Technology Co., Ltd. romanized
2024/03/16New drug · Class 1 ABP1618片 · No verified English nameCXHL2400285 Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized
2024/03/16New drug · Class 1 ABP1618片 · No verified English nameCXHL2400284 Shanghai Ai Bo Pharmaceuticals Technology Co., Ltd. romanized
2024/03/15Import · Class 2.2; 2.4 TAR-210 · No verified English nameJXHL2400065 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2024/03/15Import · Class 1 Balcinrenone达格列净胶囊 · No verified English nameJXHL2400064 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/03/15Import · Class 1 Balcinrenone达格列净胶囊 · No verified English nameJXHL2400063 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2024/03/15Generic · Class 3 Atropine Sulfate InjectionCYHS2400853 Jiangsu Kai Yuan Pharma Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized

38 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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