YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 307 drug applications between 13 April 2023 and 19 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 47 drug names.
2023/04/13 – 2023/04/19
- New acceptances this week
- 307
- Drugs with new generic filings (by drug name, de-duplicated)
- 47
- 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
307filings, 60 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 158 |
| Generic | 60 |
| New drug | 52 |
| Import | 17 |
| Import re-registration | 11 |
| Unspecified | 8 |
| Drug-device combination product | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 207 |
| TCM | 61 |
| Therapeutic biologic | 34 |
| Biologic | 2 |
| Prophylactic biologic | 2 |
| Drug-device combination | 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
47 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Diprophylline Injection | 4 | 4 | 7 |
| 2 | Lactulose Oral Solution | 3 | 2 | 34 |
| 3 | Pregabalin Oral Solution | 2 | 2 | 5 |
| 4 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 2 | 2 | 23 |
| 5 | Irbesartan and Amlodipine Tablets | 2 | 1 | 1 |
| 6 | Lacosamide Injection | 2 | 1 | 0 |
| 7 | 注射用头孢唑肟钠 · No verified English name | 2 | 1 | 4 |
| 8 | Lurasidone Hydrochloride Tablets | 2 | 1 | 2 |
| 9 | Azilsartan Medoxomil Potassium Tablets | 2 | 1 | 35 |
| 10 | Choline Fenofibrate Sustained-release Capsules | 2 | 1 | 1 |
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
176 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized | 23 | 23 | 0 |
| 2 | Changsha Ai Bei Gao Pharma Co., Ltd. romanized | 15 | 15 | 0 |
| 3 | McNeil Sweden AB | 6 | 1 | 0 |
| 4 | Eli Lilly and Company | 5 | 1 | 0 |
| 5 | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Henan Lan Tian Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Sichuan Kelun Pharmaceutical Co., Ltd. | 4 | 3 | 2 |
| 9 | Da Lian Tian Shan Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 4 | 3 | 0 |
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
97 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/04/19Import · Class 1 | Tiragolumab注射液 · No verified English nameJXSL2300069 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd |
| 2023/04/19Generic · Class 3 | Betamethasone Sodium Phosphate InjectionCYHS2301092 | Hubei Min Kang Pharma Group Co., Ltd. romanized; Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized |
| 2023/04/19Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2301089 | Hunan Xian Shi Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/04/19Generic · Class 3 | Diprophylline InjectionCYHS2301086 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2023/04/19Generic · Class 3 | Ketotifen Fumarate Nasal SprayCYHS2301084 | Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2023/04/19Generic · Class 3 | Pregabalin Oral SolutionCYHS2301083 | Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized |
| 2023/04/19Generic · Class 3 | Pregabalin Oral SolutionCYHS2301082 | Zhong Huan Pharmaceuticals Co., Ltd. romanized; Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized |
| 2023/04/19Generic · Class 3 | Progesterone InjectionCYHS2301078 | Beijing Bu Lin Bio Technology Co., Ltd. romanized; Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/04/19Generic · Class 3 | 盐酸羟甲唑啉滴眼液 · No verified English nameCYHL2300059 | Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/04/19Generic · Class 3 | 镓[68Ga]伊索曲肽注射液制备用药盒 · No verified English nameCYHL2300058 | Tianjin Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/04/19Generic · Class 3 | 镓[68Ga]伊索曲肽注射液 · No verified English nameCYHL2300057 | Tianjin Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/04/19Generic · Class 3 | Arformoterol Tartrate Inhalation SolutionCYHL2300056 | Zhang Feng Pharma Co., Ltd. romanized |
| 2023/04/19New drug · Class 3.4 | 人干扰素α2b注射液 · No verified English nameCXSS2300019 | Changchun Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2023/04/19New drug · Class 2.2 | 重组人5型腺病毒注射液 · No verified English nameCXSL2300273 | Shanghai San Wei Bio Technology Co., Ltd. romanized |
| 2023/04/19New drug · Class 1 | IASO-782 注射液 · No verified English nameCXSL2300272 | Shanghai Xun Lu Bio Technology Co., Ltd. romanized |
| 2023/04/19New drug · Class 1 | 抗人CD70 T细胞注射液 · No verified English nameCXSL2300271 | Shanghai Heng Run Da Sheng Bio Technology Co., Ltd. romanized |
| 2023/04/19New drug · Class 1 | FD-001胶囊 · No verified English nameCXHL2300391 | Chengdu Fen Di Pharma Co., Ltd. romanized |
| 2023/04/19New drug · Class 1 | FD-001胶囊 · No verified English nameCXHL2300390 | Chengdu Fen Di Pharma Co., Ltd. romanized |
| 2023/04/18Import · Class 2.3 | 尼拉帕利醋酸阿比特龙片 · No verified English nameJXHS2300035 | Janssen-Cilag International NV; PATHEON FRANCE; Xian Janssen Pharmaceutical Ltd. |
| 2023/04/18Import · Class 2.3 | 尼拉帕利醋酸阿比特龙片 · No verified English nameJXHS2300034 | Janssen-Cilag International NV; PATHEON FRANCE; Xian Janssen Pharmaceutical Ltd. |
| 2023/04/18Import · Class 1 | BAY 1747846 注射液 · No verified English nameJXHL2300087 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2023/04/18Import · Class 1 | BAY 1747846 注射液 · No verified English nameJXHL2300086 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2023/04/18Import · Class 1 | BAY 1747846 注射液 · No verified English nameJXHL2300085 | Bayer AG; Bayer Healthcare Company Ltd. |
| 2023/04/18Generic · Class 3 | Mepivacaine Hydrochloride InjectionCYHS2301073 | Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2023/04/18Generic · Class 3 | Baclofen Oral SolutionCYHS2301070 | Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2023/04/18Generic · Class 3 | Diquafosol Sodium Eye DropsCYHL2300055 | Can Tian Pharmaceutical (Zhongguo) Co., Ltd. romanized |
| 2023/04/18New drug · Class 1.1 | 养阴舒肝颗粒 · No verified English nameCXZL2300027 | Guangzhou Pharmaceuticals Research Zong Yuan Co., Ltd. romanized |
| 2023/04/18New drug · Class 1 | CF04滴眼液 · No verified English nameCXSL2300270 | Shanghai Pu You Biopharmaceuticals Co., Ltd. romanized |
| 2023/04/18New drug · Class 1 | CF04滴眼液 · No verified English nameCXSL2300269 | Shanghai Pu You Biopharmaceuticals Co., Ltd. romanized |
| 2023/04/18New drug · Class 1 | CF04滴眼液 · No verified English nameCXSL2300268 | Shanghai Pu You Biopharmaceuticals Co., Ltd. romanized |
67 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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