YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 148 drug applications between 22 December 2022 and 28 December 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 27, covering 18 drug names.
2022/12/22 – 2022/12/28
- New acceptances this week
- 148
- Drugs with new generic filings (by drug name, de-duplicated)
- 18
- 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
148filings, 27 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 69 |
| Generic | 27 |
| Import | 21 |
| New drug | 20 |
| Unspecified | 6 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 98 |
| Therapeutic biologic | 26 |
| TCM | 18 |
| 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
18 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 | Voriconazole Tablets | 2 | 1 | 1 |
| 4 | Nalbuphine Hydrochloride Injection | 2 | 1 | 11 |
| 5 | Carbocisteine Oral Solution | 2 | 1 | 6 |
| 6 | Propofol Medium And Long Chain Fat Emulsion Injection | 1 | 1 | 3 |
| 7 | Palbociclib Tablets | 1 | 1 | 2 |
| 8 | Desonide Cream | 1 | 1 | 0 |
| 9 | Olmesartan Medoxomil Orally Disintegrating Tablets | 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
96 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Qilu Pharmaceutical Co., Ltd. | 5 | 3 | 1 |
| 2 | Lv Ye Jia Ao Pharmaceutical Shijiazhuang Co., Ltd. romanized | 5 | 1 | 5 |
| 3 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 4 | 4 | 2 |
| 4 | Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized | 4 | 2 | 4 |
| 5 | Idience Co. Ltd. | 4 | 1 | 0 |
| 6 | Xian Tang Chen Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 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
48 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/12/28Import · Class 2.4 | Selumetinib胶囊 · No verified English nameJXHL2200353 | ASTRAZENECA UK LIMITED; AstraZeneca Investment (China) Co. Limited |
| 2022/12/28Import · Class 2.4 | Selumetinib胶囊 · No verified English nameJXHL2200352 | ASTRAZENECA UK LIMITED; AstraZeneca Investment (China) Co. Limited |
| 2022/12/28Generic · Class 3 | Nalbuphine Hydrochloride InjectionCYHS2202118 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/12/28Generic · Class 3 | Nalbuphine Hydrochloride InjectionCYHS2202117 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2022/12/28Generic · Class 3 | 氟[18F]化钠注射液 · No verified English nameCYHS2202115 | Yuan Zi Gao Ke Co., Ltd. romanized |
| 2022/12/28Generic · Class 3 | Carbocisteine Oral SolutionCYHS2202114 | Beijing Kang Cheng Bai Chun Bio Technology Co., Ltd. romanized; Beijing Hua Run Gao Ke Tian Ran Drug Co., Ltd. romanized |
| 2022/12/28Generic · Class 3 | Carbocisteine Oral SolutionCYHS2202113 | Beijing Kang Cheng Bai Chun Bio Technology Co., Ltd. romanized; Beijing Hua Run Gao Ke Tian Ran Drug Co., Ltd. romanized |
| 2022/12/28Generic · Class 3 | Olmesartan Medoxomil Orally Disintegrating TabletsCYHS2202112 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2022/12/28Generic · Class 3 | 琥珀酸地文拉法辛缓释片 · No verified English nameCYHS2202106 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2022/12/28New drug · Class 1 | LP002注射液 · No verified English nameCXSL2200620 | Tai Zhou Hou De Ao Ke Technology Co., Ltd. romanized |
| 2022/12/28New drug · Class 1 | 迪诺仑赛注射液 · No verified English nameCXSL2200619 | Beijing Yong Tai Rui Ke Bio Technology Co., Ltd. romanized |
| 2022/12/28New drug · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2200955 | Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized |
| 2022/12/28New drug · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2200954 | Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized |
| 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 |
18 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.