YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 352 drug applications between 6 October 2024 and 12 October 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 71 drug names.
2024/10/06 – 2024/10/12
- New acceptances this week
- 352
- Drugs with new generic filings (by drug name, de-duplicated)
- 71
- Accepted this week, now under review
- 2
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
352filings, 95 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 155 |
| Generic | 95 |
| New drug | 53 |
| Import | 26 |
| Unspecified | 13 |
| Import re-registration | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 237 |
| TCM | 58 |
| Therapeutic biologic | 51 |
| Biologic | 4 |
| Prophylactic biologic | 2 |
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
71 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Fusidic Acid Cream | 4 | 2 | 15 |
| 2 | Magnesium Sulfate, Sodium Sulfate and Potassium Sulfate Concentrate Oral Solution | 3 | 3 | 8 |
| 3 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 4 | Bupivacaine Hydrochloride Injection | 3 | 1 | 4 |
| 5 | Iguratimod Tablets | 2 | 2 | 23 |
| 6 | ω-3 Fish Oil Fat Emulsion Injection | 2 | 1 | 6 |
| 7 | Piracetam Injection | 2 | 1 | 9 |
| 8 | Brexpiprazole Orally Disintegrating Tablets | 2 | 1 | 10 |
| 9 | Empagliflozin Tablets | 2 | 1 | 18 |
| 10 | Topiramate Tablets | 2 | 1 | 0 |
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
219 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Janssen-Cilag International NV | 7 | 5 | 0 |
| 2 | Bristol-Myers Squibb Pharma EEIG | 7 | 2 | 0 |
| 3 | Bard Pharmaceuticals Limited | 6 | 6 | 0 |
| 4 | Jiangsu Shen Hua Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | AstraZeneca AB | 5 | 4 | 0 |
| 6 | Merck Sharp & Dohme B.V. | 5 | 3 | 0 |
| 7 | Eli Lilly and Company | 5 | 2 | 0 |
| 8 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 9 | Guizhou Ke Lun Pharma Co., Ltd. romanized | 5 | 2 | 1 |
| 10 | CISEN PHARMACEUTICAL CO., LTD. | 4 | 3 | 4 |
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
107 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/10/12Import · Class 3.1 | 布西珠单抗注射液 · No verified English nameJXSS2400089 | Novartis Pharma Schweiz AG; Novartis Pharma Stein AG; Beijing Novartis Pharma Co. Ltd. |
| 2024/10/12Import · Class 3.1 | 布西珠单抗注射液 · No verified English nameJXSS2400088 | Novartis Pharma Schweiz AG; Alcon-Couvreur N.V.; Beijing Novartis Pharma Co. Ltd. |
| 2024/10/12Import · Class 1 | Mezagitamab注射剂 · No verified English nameJXSL2400193 | Takeda Development Center Americas Inc.; Takeda APAC Biopharmaceutical Research and Development Company Limited |
| 2024/10/12Import · Class 1 | HCB301注射液 · No verified English nameJXSL2400192 | FBD Biologics Limited; Shanghai Hanchor Biotech Inc. |
| 2024/10/12Import · Class 2.4 | Lenvatinib Mesilate CapsulesJXHS2400083 | Eisai Europe Limited; Eisai Co. Ltd. |
| 2024/10/12Import · Class 2.4 | Lenvatinib Mesilate CapsulesJXHS2400082 | Eisai Europe Limited; Eisai Co. Ltd. |
| 2024/10/12Generic · Class 3 | Ampicillin Sodium For InjectionCYHS2403423 | Hunan Bai Qi He Drug Research and Development Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2024/10/12Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2403421 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2024/10/12Generic · Class 3 | Cimetidine InjectionCYHS2403418 | Da Li Pharma Co., Ltd. romanized |
| 2024/10/12Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2403414 | Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2024/10/12Generic · Class 3 | Brexpiprazole Orally Disintegrating TabletsCYHS2403412 | Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2024/10/12Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2403411 | Jiangsu Qian Ren Bio Technology Co., Ltd. romanized |
| 2024/10/12Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2403408 | Jiangsu Qian Ren Bio Technology Co., Ltd. romanized |
| 2024/10/12Generic · Class 3 | Epalrestat TabletsCYHS2403407 | Zhejiang Dong Ya Pharma Co., Ltd. romanized |
| 2024/10/12Generic · Class 3 | 比拉斯汀口崩片 · No verified English nameCYHS2403406 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
| 2024/10/12Generic · Class 3 | Metoprolol Tartrate InjectionCYHS2403405 | Shenzhen Ge Lai En Biopharmaceuticals Technology Co., Ltd. romanized; Zhongshan Wanhan Pharmaceuticals Co., Ltd. |
| 2024/10/12Generic · Class 3 | Cytarabine InjectionCYHS2403404 | Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized |
| 2024/10/12Generic · Class 3 | Cytarabine InjectionCYHS2403402 | Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized |
| 2024/10/12Generic · Class 3 | Phloroglucinol Orally Disintegrating TabletsCYHS2403400 | Nanjing Ai De Kai Teng Biopharmaceuticals Co., Ltd. romanized; Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized |
| 2024/10/12Generic · Class 3 | Dobutamine Hydrochloride InjectionCYHS2403394 | Shanghai Zhao Hui Pharma Co., Ltd. romanized |
| 2024/10/12Generic · Class 3 | Sodium Thiosulfate InjectionCYHS2403392 | Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized |
| 2024/10/12Generic · Class 3 | Potassium Chloride InjectionCYHS2403391 | Heilongjiang Sheng Zhi Run Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2024/10/12New drug · Class 1.1 | 参黛直肠栓 · No verified English nameCXZL2400066 | Beijing Ying Ke Rui Innovation Drug Research Co., Ltd. romanized |
| 2024/10/12New drug · Class 3.3 | 德谷胰岛素注射液 · No verified English nameCXSS2400110 | Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized |
| 2024/10/12New drug · Class 3.3 | 德谷胰岛素注射液 · No verified English nameCXSS2400109 | Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized |
| 2024/10/12New drug · Class 1 | 注射用ILB-3101 · No verified English nameCXSL2400691 | Ying Nuo Hu Pharmaceuticals (Hangzhou) Co., Ltd. romanized |
| 2024/10/12New drug · Class 1 | 注射用SHR-A1811 · No verified English nameCXSL2400690 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/10/12New drug · Class 1 | 注射用SHR-9839 · No verified English nameCXSL2400689 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/10/12New drug · Class 1 | 注射用ZW25 · No verified English nameCXSL2400688 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2024/10/12New drug · Class 1 | 注射用SHR-9839 (sc) · No verified English nameCXSL2400687 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
77 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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