YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 145 drug applications between 21 December 2022 and 27 December 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 20, covering 16 drug names.
2022/12/21 – 2022/12/27
- New acceptances this week
- 145
- Drugs with new generic filings (by drug name, de-duplicated)
- 16
- 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
145filings, 20 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 71 |
| Import | 21 |
| Generic | 20 |
| New drug | 18 |
| Unspecified | 11 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 98 |
| Therapeutic biologic | 36 |
| TCM | 8 |
| 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
16 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sitagliptin and Metformin Hydrochloride Extended-release Tablets | 3 | 1 | 12 |
| 2 | Voriconazole Tablets | 2 | 1 | 1 |
| 3 | Iopromide Injection | 2 | 1 | 27 |
| 4 | Propofol Medium And Long Chain Fat Emulsion Injection | 1 | 1 | 3 |
| 5 | Tadalafil Tablets | 1 | 1 | 23 |
| 6 | Allopurinol Tablets | 1 | 1 | 4 |
| 7 | Salbutamol Sulfate Inhalation Solution | 1 | 1 | 2 |
| 8 | Palbociclib Tablets | 1 | 1 | 2 |
| 9 | Desonide Cream | 1 | 1 | 0 |
| 10 | Formoterol Fumarate Inhalation Solution | 1 | 1 | 5 |
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
88 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hangzhou Jiu Yuan Ji Yin Gong Cheng Co., Ltd. romanized | 10 | 1 | 0 |
| 2 | Shandong Wei Gao Shu Xue Technology Zhuang Bei Co., Ltd. romanized | 9 | 3 | 0 |
| 3 | An Qing Hui Yin Bi Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 4 | Idience Co. Ltd. | 4 | 1 | 0 |
| 5 | Microlabs | 3 | 3 | 0 |
| 6 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 3 | 3 | 1 |
| 7 | Amgen Inc. | 3 | 1 | 0 |
| 8 | Otsuka Pharmaceutical Co.,Ltd. | 3 | 1 | 0 |
| 9 | Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized | 3 | 1 | 0 |
| 10 | Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized | 3 | 1 | 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
38 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/12/27Import · Class 3.3 | 甘精胰岛素注射液 · No verified English nameJXSS2200043 | Eli Lilly Nederland B.V.; Lilly France S.A.S.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/12/27Import · Class 3.3 | 甘精胰岛素注射液 · No verified English nameJXSS2200042 | Eli Lilly Nederland B.V.; Lilly France S.A.S.; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/12/27Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2202105 | Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized |
| 2022/12/27Generic · Class 3 | Desonide CreamCYHS2202104 | Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized |
| 2022/12/27Generic · Class 3 | Formoterol Fumarate Inhalation SolutionCYHS2202102 | Li Sheng Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2022/12/27Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2202101 | Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2022/12/27Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2202100 | Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2022/12/27Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2202099 | Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2022/12/27New drug · Class 1 | 注射用SMET12 · No verified English nameCXSL2200618 | Zhejiang Shi Mai Pharma Co., Ltd. romanized |
| 2022/12/27New drug · Class 1 | HB0025注射液 · No verified English nameCXSL2200617 | Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized; Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized |
| 2022/12/27New drug · Class 1 | 注射用重组人白介素22-Fc融合蛋白 · No verified English nameCXSL2200616 | Yi Yi Biopharmaceuticals Kai Fa (Shanghai) Co., Ltd. romanized |
| 2022/12/27New drug · Class 1 | LP-003 注射液 · No verified English nameCXSL2200615 | Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2022/12/27New drug · Class 1 | YZJ-5053片 · No verified English nameCXHL2200953 | Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/27New drug · Class 1 | YZJ-5053片 · No verified English nameCXHL2200952 | Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/27New drug · Class 1 | YZJ-5053片 · No verified English nameCXHL2200951 | Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/26New drug · Class 1.1 | 苏合颗粒 · No verified English nameCXZL2200055 | Chongqing Ju Qi Nuo Mei Pharmaceutical Co., Ltd. romanized; Beijing Zhong Pharmaceuticals University romanized |
| 2022/12/26New drug · Class 2.3 | 痹克片 · No verified English nameCXZL2200054 | Hefei Jin Yue Pharmaceutical Co., Ltd. romanized |
| 2022/12/26New drug · Class 1 | YH008注射用冻干粉 · No verified English nameCXSL2200614 | Name not romanized |
| 2022/12/26New drug · Class 2.2 | BCM347口溶膜 · No verified English nameCXHL2200950 | Shanghai Bo Zhi Yan Xin Drug Technology Co., Ltd. romanized |
| 2022/12/26New drug · Class 1 | HRS-5965片 · No verified English nameCXHL2200949 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/12/26New drug · Class 1 | HRS-5965片 · No verified English nameCXHL2200948 | Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/12/24Import · Class 3.1 | 依库珠单抗注射液 · No verified English nameJXSS2200041 | Alexion Europe SAS; Alexion Athlone Manufacturing Facility (AAMF); AstraZeneca Investment (China) Co. Ltd |
| 2022/12/24Import · Class 1 | LY3473329片 · No verified English nameJXHL2200351 | Eli Lilly and Company |
| 2022/12/24Import · Class 1 | LY3473329片 · No verified English nameJXHL2200350 | Eli Lilly and Company |
| 2022/12/23Import · Class 1 | AMG 451 · No verified English nameJXSL2200211 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2022/12/23Import · Class 1 | AMG 451 · No verified English nameJXSL2200210 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2022/12/23Import · Class 1 | AMG 451 · No verified English nameJXSL2200209 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2022/12/23Import · Class 1 | Cetrelimab 注射液 · No verified English nameJXSL2200208 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/12/23Import · Class 1 | Cetrelimab 注射液(皮下注射) · No verified English nameJXSL2200207 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/12/23Import · Class 1 | MEDI5752 · No verified English nameJXSL2200206 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
8 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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