YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 394 drug applications between 18 December 2024 and 24 December 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 111, covering 76 drug names.
2024/12/18 – 2024/12/24
- New acceptances this week
- 394
- Drugs with new generic filings (by drug name, de-duplicated)
- 76
- Accepted this week, now under review
- 3
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
394filings, 111 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 178 |
| Generic | 111 |
| New drug | 66 |
| Import | 21 |
| Unspecified | 12 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 269 |
| TCM | 71 |
| Therapeutic biologic | 49 |
| Biologic | 4 |
| Prophylactic biologic | 1 |
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
76 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Safinamide Methansulfonate Tablets | 6 | 3 | 20 |
| 2 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 3 | Tadalafil Tablets | 3 | 1 | 23 |
| 4 | Lidocaine and Prilocaine Cream | 3 | 1 | 24 |
| 5 | Sildenafil Citrate Tablets | 3 | 1 | 12 |
| 6 | Alfacalcidol Soft Capsules | 3 | 1 | 9 |
| 7 | 阿贝西利片 · No verified English name | 3 | 1 | 2 |
| 8 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 9 | Bumetanide Injection | 2 | 2 | 13 |
| 10 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 2 | 2 | 9 |
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
238 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Qidu Pharmaceutical Co., Ltd. | 9 | 3 | 0 |
| 2 | Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized | 5 | 5 | 0 |
| 3 | AstraZeneca AB | 5 | 3 | 0 |
| 4 | Pfizer Inc. | 5 | 3 | 0 |
| 5 | Novartis Pharma AG | 5 | 2 | 0 |
| 6 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. | 5 | 2 | 1 |
| 7 | Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | 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
122 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/12/24Import · Class 1 | Tiragolumab注射液 · No verified English nameJXSL2400246 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2024/12/24Generic · Class 3 | Bumetanide InjectionCYHS2404492 | Henan Qun Yi Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized |
| 2024/12/24Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2404487 | Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Shandong Yu Xin Pharma Co., Ltd. romanized |
| 2024/12/24Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2404486 | Hubei Guang Ji Pharma Co., Ltd. romanized; Lang Tian Pharma (Hubei) Co., Ltd. romanized |
| 2024/12/24Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2404473 | Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized |
| 2024/12/24Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2404472 | Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized |
| 2024/12/24Generic · Class 3 | Minoxidil LinimentCYHS2404470 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized; Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized |
| 2024/12/24Generic · Class 3 | Minoxidil LinimentCYHS2404469 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized; Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized |
| 2024/12/24Generic · Class 3 | Hydrotalcite SuspensionCYHS2404466 | Hunan Pu Dao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2024/12/24Generic · Class 3 | Ceftaroline Fosamil for InjectionCYHL2400268 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2024/12/24Generic · Class 3 | Ceftaroline Fosamil for InjectionCYHL2400267 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2024/12/24New drug · Class 1.1 | 连参更年颗粒 · No verified English nameCXZL2400095 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized; Shanghai Tu Feng Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Zhong Pharmaceuticals University romanized |
| 2024/12/24New drug · Class 1 | 注射用YB-01 · No verified English nameCXSL2400895 | Yuan Ben (Zhuhai Heng Qin) Bio Technology Co., Ltd. romanized |
| 2024/12/24New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSL2400894 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2024/12/24New drug · Class 1 | HS-20117注射液 · No verified English nameCXSL2400893 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2024/12/24New drug · Class 1 | SENL103自体T细胞注射液 · No verified English nameCXSL2400892 | Hebei Sen Lang Bio Technology Co., Ltd. romanized |
| 2024/12/24New drug · Class 1 | 培来加南喷雾剂 · No verified English nameCXHS2400130 | Pu Lai Pharmaceuticals (Jiangsu) Co., Ltd. romanized |
| 2024/12/24New drug · Class 2.2 | LD111118 · No verified English nameCXHL2401439 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2024/12/24New drug · Class 1 | 注射用iSAP-0909 · No verified English nameCXHL2401438 | Ai Sai Pu (Beijing) Bio Technology Co., Ltd. romanized |
| 2024/12/24New drug · Class 1 | HS-10370片 · No verified English nameCXHL2401437 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/24New drug · Class 2.2; 2.4 | GRK-007 鼻喷雾剂 · No verified English nameCXHL2401436 | Hui An Kai (Xiamen) Pharmaceuticals Technology Co., Ltd. romanized; Suzhou Ge Lan Ke Pharmaceuticals Technology Co., Ltd. romanized; Quan Zhou Hai Chuang Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/24New drug · Class 2.2; 2.4 | GRK-007 鼻喷雾剂 · No verified English nameCXHL2401435 | Hui An Kai (Xiamen) Pharmaceuticals Technology Co., Ltd. romanized; Suzhou Ge Lan Ke Pharmaceuticals Technology Co., Ltd. romanized; Quan Zhou Hai Chuang Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/12/24New drug · Class 1 | WS-0101溶液 · No verified English nameCXHL2401434 | Name not romanized |
| 2024/12/24New drug · Class 1 | SWA1211片 · No verified English nameCXHL2401433 | Beijing Wang Shi Zhi Hui Technology Co., Ltd. romanized |
| 2024/12/24New drug · Class 1 | SWA1211片 · No verified English nameCXHL2401432 | Beijing Wang Shi Zhi Hui Technology Co., Ltd. romanized |
| 2024/12/24New drug · Class 1 | ZD526鼻喷雾剂 · No verified English nameCXHL2401431 | Hangzhou Zhi He Dan Gu Biopharmaceuticals Co., Ltd. romanized |
| 2024/12/24New drug · Class 1 | HL-1186片 · No verified English nameCXHL2401430 | Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2024/12/23Generic · Class 3 | Metaraminol Tartrate InjectionCYHS2404463 | Henan Qun Yi Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Xin He Yuan Sheng Pharmaceutical Co., Ltd. romanized |
| 2024/12/23Generic · Class 3 | Pregabalin Oral SolutionCYHS2404462 | Yue Yang Xin Hua Da Pharmaceutical Co., Ltd. romanized |
| 2024/12/23New drug · Class 1 | IBR854细胞注射液 · No verified English nameCXSL2400891 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
92 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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