YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 205 drug applications between 23 December 2022 and 29 December 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 46, covering 32 drug names.
2022/12/23 – 2022/12/29
- New acceptances this week
- 205
- Drugs with new generic filings (by drug name, de-duplicated)
- 32
- 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
205filings, 46 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 92 |
| Generic | 46 |
| New drug | 36 |
| Import | 21 |
| Unspecified | 5 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 149 |
| Therapeutic biologic | 28 |
| TCM | 22 |
| Biologic | 3 |
| Prophylactic biologic | 3 |
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
32 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Paliperidone Palmitate Injection | 5 | 1 | 8 |
| 2 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 3 | 1 | 12 |
| 3 | Esmolol Hydrochloride Injection | 2 | 2 | 3 |
| 4 | Voriconazole Tablets | 2 | 1 | 1 |
| 5 | Topiramate Extended-release Capsules | 2 | 1 | 0 |
| 6 | 水合氯醛灌肠剂 · No verified English name | 2 | 1 | 1 |
| 7 | Nalbuphine Hydrochloride Injection | 2 | 1 | 11 |
| 8 | Sucralfate Oral Suspension | 2 | 1 | 4 |
| 9 | Carbocisteine Oral Solution | 2 | 1 | 6 |
| 10 | Sugammadex Sodium Injection | 2 | 1 | 6 |
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
127 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Xian Tang Chen Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 2 | Qilu Pharmaceutical Co., Ltd. | 5 | 3 | 1 |
| 3 | Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized | 5 | 1 | 5 |
| 4 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 4 | 4 | 2 |
| 5 | Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 4 | 2 | 3 |
| 7 | Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized | 4 | 2 | 4 |
| 8 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Idience Co. Ltd. | 4 | 1 | 0 |
| 10 | Yuan Zi Gao Ke Co., Ltd. romanized | 3 | 3 | 1 |
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
74 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/12/29Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2202136 | Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2022/12/29Generic · Class 3 | Esmolol Hydrochloride InjectionCYHS2202135 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2022/12/29Generic · Class 3 | Sucralfate Oral SuspensionCYHS2202134 | Guangdong Zhong Sheng Pharma Co., Ltd. romanized; Guangdong Hua Nan Pharma Group Co., Ltd. romanized |
| 2022/12/29Generic · Class 3 | Sucralfate Oral SuspensionCYHS2202133 | Guangdong Zhong Sheng Pharma Co., Ltd. romanized; Guangdong Hua Nan Pharma Group Co., Ltd. romanized |
| 2022/12/29Generic · Class 3 | Nicorandil for InjectionCYHS2202132 | Tian Da Pharma (Yunnan) Co., Ltd. romanized |
| 2022/12/29Generic · Class 3 | Ambroxol Hydrochloride DropsCYHS2202127 | Hefei En Rui Te Pharma Co., Ltd. romanized |
| 2022/12/29Generic · Class 3 | Metaraminol Tartrate InjectionCYHS2202126 | Hainan Tian Sheng Bao He Bio Technology Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2022/12/29Generic · Class 3 | Esketamine Hydrochloride InjectionCYHS2202125 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/12/29Generic · Class 3 | Topiramate Extended-release CapsulesCYHS2202124 | Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized; Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized |
| 2022/12/29Generic · Class 3 | Topiramate Extended-release CapsulesCYHS2202123 | Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized; Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized |
| 2022/12/29Generic · Class 3 | 水合氯醛灌肠剂 · No verified English nameCYHS2202122 | Hainan Tian Sheng Bao He Bio Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2022/12/29Generic · Class 3 | 水合氯醛灌肠剂 · No verified English nameCYHS2202121 | Hainan Tian Sheng Bao He Bio Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2022/12/29New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2200624 | Shenzhen Shi Yin Guan Bio Technology Co., Ltd. romanized |
| 2022/12/29New drug · Class 1 | 注射用ATG-022 ADC · No verified English nameCXSL2200623 | De Qi (Hangzhou) Bio Co., Ltd. romanized |
| 2022/12/29New drug · Class 1 | BPB-101双抗注射液 · No verified English nameCXSL2200622 | Bei Da Pharma Co., Ltd. romanized |
| 2022/12/29New drug · Class 1 | CC312冻干粉针剂 · No verified English nameCXSL2200621 | Hui He Bio Technology (Shanghai) Co., Ltd. romanized |
| 2022/12/29New drug · Class 1 | AZD4547片 · No verified English nameCXHL2200968 | Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/29New drug · Class 1 | AZD4547片 · No verified English nameCXHL2200967 | Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/29New drug · Class 1 | 氟[18F]贝他嗪注射液 · No verified English nameCXHL2200966 | Yuan Zi Gao Ke Co., Ltd. romanized |
| 2022/12/29New drug · Class 1 | 氟[18F]司他明注射液 · No verified English nameCXHL2200965 | Yuan Zi Gao Ke Co., Ltd. romanized |
| 2022/12/29New drug · Class 2.4 | 海曲泊帕乙醇胺片 · No verified English nameCXHL2200964 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/12/29New drug · Class 1 | BPI-472372片 · No verified English nameCXHL2200963 | Bei Da Pharma Co., Ltd. romanized |
| 2022/12/29New drug · Class 1 | BPI-472372片 · No verified English nameCXHL2200962 | Bei Da Pharma Co., Ltd. romanized |
| 2022/12/29New drug · Class 1 | TQ05105片 · No verified English nameCXHL2200961 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2022/12/29New drug · Class 1 | RAY1225注射液 · No verified English nameCXHL2200960 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized |
| 2022/12/29New drug · Class 1 | RAY1225注射液 · No verified English nameCXHL2200959 | Guangdong Zhong Sheng Rui Chuang Bio Technology Co., Ltd. romanized |
| 2022/12/29New drug · Class 1 | BGB-21447片 · No verified English nameCXHL2200958 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2022/12/29New drug · Class 1 | BGB-21447片 · No verified English nameCXHL2200957 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2022/12/29New drug · Class 1 | 伊匹乌肽滴眼液 · No verified English nameCXHL2200956 | Yi Cheng Kang Tai (Xiamen) Bio Technology Co., Ltd. romanized |
| 2022/12/28Import · Class 2.4 | Selumetinib胶囊 · No verified English nameJXHL2200353 | ASTRAZENECA UK LIMITED; AstraZeneca Investment (China) Co. Limited |
44 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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